dijous, 31 d’agost del 2017

Charges filed by US in Medrobotics trade secret case after CEO spots suspect in secured office

Medrobotics

An individual has been arrested and charged with entering robotic medtech firm Medrobotics‘ headquarters in an attempt to steal trade secrets, according to court documents from the US District Court for the District of Massachusetts filed this week.

Court documents identify the suspect as 44-year old Dong Liu, who “appears to be a dual citizen of both Canada and China.” Upon arrest, Liu was reported to have current passports from both countries.

According to court documents, Liu entered the US through the Canadian border on Aug. 27th, and proceeded to enter the Medrobotics Raynham, Mass.-based headquarters the next day.

Medrobotics CEO Samuel Straface spotted Liu with 3 laptop computers in a secured company conference room at around 7:30 p.m. on the 28th, according to court documents.

Straface approached Liu to find out his identity and was met with a muffled response, court documents report. Liu later identified himself as the company’s sales director for its European division, who Straface responded had been out of the country for 3 weeks.

Liu claimed he was in the offices to to meet with the company’s head of intellectual property, which Straface rebutted was not true, as the IP head had no such meetings scheduled. Liu then named the CEO of the company and stated he had a scheduled meeting with him, which Straface also rebutted as he was the CEO and had no such plans, court documents report.

Straface said he saw Liu begin to power down 2 or 3 of his computers after this exchange, according to court documents.

Later, Liu claimed that he was doing patent work for a Chinese law firm and showed CEO Straface his online law-firm biography, which “stated that he is a senior partner and a patent attorney at Boss & Young Patent and Trademark Law Office in Beijing, China,” according to court documents. Liu’s LinkedIn profile claims he “lead[s] the firm’s Intellectual Property (IP) practice in medical device, bio-tech, clean-tech, and other emerging high-tech areas.”

Straface proceeded to notify the Raynham police, who later arrested Liu after saying that “it appeared odd that Liu was talking to the company’s CEO but didn’t recognize him and had been sitting in a conference room for a long time and had not tried to get anybody’s attention while inside the building,” according to court records.

Upon questioning, Liu said he had entered the building before 5:00 p.m., and had been let into the secured room by a man – though he later changed his story to say that he had been let in by a woman, “whom he could not remember.”

The FBI confiscated a number of electronic equipment, including 2 laptops, 2 smartphones and a number of SIM cards, an ipad, 2 digital camcorders and a wealth of digital storage equipment including flash drives and external hard drives, court documents report.

The Bureau said the equipment “could be used to acquire, store, and/or transmit computer and/or audiovisual data about and belonging to Medrobotics,” according to court documents.

Medrobotics CEO Straface said that “people or companies from mainland China have been trying to develop a business relationship with Medrobotics for about 10 years,” and that he had been approached approximately 6 times. Straface said he normally arranged meetings in Boston and had never met any such individuals at the company’s Raynham headquarters, court documents report.

“Although it is too early to tell whether Liu succeeded in obtaining any trade secrets or other corporate information or whether he installed any malware on Medrobotics’ computer network in order to do so, or whether Liu could even have been successful in doing so, all of the above facts and inferences give probable cause to believe that he took substantial steps to do so and therefore attempted to do so,” an FBI special agent wrote in an affidavit.

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Apollo Endosurgery wins CE Mark for 12-month Orbera weight loss balloon

Apollo Endosurgery

Apollo Endosurgery said today it won an expanded CE Mark approval for its Orbera weight loss system, extending the indwell period of the gastric balloon from 6 months to a 12 month treatment period.

The balloon device is designed to be inserted non-surgically in obese patients with body mass indexes of 30 to 40, the Austin, Texas-based company said. After insertion, the balloon is inflated to fill space in the stomach.

“I’ve been using Orbera since 1999 and have helped thousands of patients lose weight with my Orbera program. Now with Orbera365 patients will have the possibility of getting better weight loss results because in my experience the longer the treatment the more weight patients tend to lose. Actually, using Orbera365 our patients will now have twice as long to change their eating behaviors and ensure long lasting results,” Alfredo Genco of Rome’s Sapienza University said in a prepared statement.

Apollo Endosurgery said it expects to begin commercialization of the Orbera365 device in the 4th quarter of 2017.

“The CE Mark approval of Orbera365 has been a significant accomplishment for Apollo and involved a comprehensive review of clinical and non-clinical data by a regulatory body in a market with deep understanding and experience with intragastric balloon therapy. Obtaining CE Mark approval now for Orbera365 is a strong testimony of the relevance and significance of more than a decade of the Orbera system’s safety and efficacy data as supported by more than 277,000 distributed implants and 230 published peer-reviewed papers,” Apollo CEO Todd Newton said in a press release.

In July, Apollo Endosurgery said it closed its recently announced public offering, raising $36 million.

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MassDevice.com +5 | The top 5 medtech stories for August 31, 2017

plus5-node

Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.

Get this in your inbox everyday by subscribing to our newsletters.

 

5. This exoskeleton could eliminate crouch gait

MassDevice.com news

The National Institutes of Health has created what it claims is the first robotic exoskeleton that is designed to treat crouch gait in children who have cerebral palsy.

Crouch gait occurs when there is excessive bending of the knees while walking. It is a common condition in children with cerebral palsy. The NIH reports that even with conventional treatments, crouch gait can develop into the degeneration of walking function and eventually the loss of walking ability in about half of adults with the disorder. Read more


4. Abbott’s FreeStyle Libre wins reimbursement in Japan

MassDevice.com news

Abbott said today that the Ministry of Health Labor and Welfare in Japan has granted national reimbursement for the company’s FreeStyle Libre glucose monitoring system.

The FreeStyle Libre system uses a small sensor worn on the back of the upper arm to measure glucose every minute in interstitial fluid through a filament inserted under the skin. Abbott said its system can produce a glucose reading painlessly in less than 1 second by scanning a reader over the sensor. Read more


3. HeartFlow wins positive policy decisions from 3 BCBS providers

MassDevice.com news

HeartFlow said today it won positive medical policies for its HeartFlow FFRct fractional flow reserve analysis system from 3 separate Blue Cross Blue Shield providers.

The Redwood City, Calif.-based company said that Anthem Blue Cross Blue Shield, Blue Shield of California and Blue Cross and Blue Shield of Alabama issued positive medical policies supporting the use of the FFRct technology following coronary computed tomography angiograms for members with stable chest pain. Read more


2. BrainScope raises $16m for TBI assessment device

MassDevice.com news

BrainScope said yesterday that it closed a $16 million funding round for the eponymous traumatic brain injury assessment device it developed.

Bethesda, Md.-based BrainScope said new backer DBL Partners joined existing investors Revolution LLC, ZG Ventures, Maryland Venture Fund participated in the round, along with unnamed existing and new investors in the round. Read more


1. Philips subsidiary Spectranetics recalls Bridge occlusion balloon

MassDevice.com news

Royal Philips subsidiary Spectranetics recalled its Bridge occlusion balloon after receiving reports of blocked guidewire lumens.

The Bridge device is used to temporarily block the superior vena cava for emergency control of hemorrhage. Spectranetics said the August 25 recall was prompted by nine reports of blocked guidewire lumens, although no deaths or serious injuries were reported. Read more

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Investors sue Teva over $41B Actavis deal

Teva PharmaceuticalTeva Pharmaceuticals (NYSE:TEVA) and a handful of current and former executives were hit with a lawsuit yesterday alleging that the drugmaker hid the negative fallout linked to its $40.5 billion purchase of Actavis Generics.

Barry Baker, a Teva investor, claimed that the company, former CEO Erez Vigodman, ex-CFO Eyal Desheh and interim CEO Yitzhak Peterburg issued false and misleading statements after the acquisition which caused shares in Teva to trade at artificially high levels.

Get the full story at our sister site, Drug Delivery Business News.

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CSA Medical wins another FDA expansion for TruFreeze cryotherapy

CSA Medical

Endoscopic cryo-ablation company CSA Medical said today it won expanded FDA 510(k) clearance for its TruFreeze spray cryotherapy system, now cleared for use on patients with Barrett’s esophagus with low grade dysplasia.

With the clearance, the device is now approved for both low and high grade dysplasia as well as malignancies, the Boston-based company said.

“Over the past few years, studies have underscored the potential risk for Barrett’s esophagus with low grade dysplasia to progress to esophageal adenocarcinoma. Intervening at this level of dysplasia has become common practice and is recognized in our society guidelines.  My colleagues and I have used liquid nitrogen spray cryotherapy for over a decade to treat Barrett’s esophagus with high levels of efficacy and patient tolerability.  With approval of this expanded label, the FDA has recognized spray cryotherapy’s ability to positively impact the lives of our Barrett’s patients,” Dr. Michael Smith of New York’s Mount Sinai hospitals said in a press release.

The TruFreeze system is designed as a cryosurgical tool designed for use in dermatology, gynecology, general surgery and to ablate benign and malignant lesions.

The company touts the TruFreeze device as the only ablation technology designed to ablate Barrett’s Esophagus with a high grade dysplasia or cancers as such as in the esophagus with a non-contact liquid nitrogen spray cryotherapy system.

“We are pleased to have obtained FDA clearance to expand our indications for use to include Barrett’s Esophagus with low grade dysplasia as an example of benign disease ablation as well as our present indication for Barrett’s Esophagus with high grade dysplasia and malignant disease ablation.  The data set that formed the basis of this claim came from our prospective post market registry that delineated ablation using truFreeze spray cryotherapy as specified in our instructions for use.  Achieving a CE-D rate of 95.5% in this patient cohort is in keeping with numerous previously published truFreeze reports,” CSA Medical prez & CEO Dr. Ellen Sheets said in a prepared statement.

In July, CSA Medical said it won FDA 510(k) clearance for a 3rd spray kit, the rapid AV spray kit, for its TruFreeze system.

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SteadyMed shares tumble after FDA refuses to review Trevyent NDA

SteadyMed TherapeuticsShares in SteadyMed (NSDQ:STDY) fell more than -35% today after the company announced that the FDA will not review the new drug application for its drug-device combo product, Trevyent.

The company received a refused to file letter, indicating that its NDA is incomplete and that the regulatory agency will not look it over. This is the second RTF letter issued by the FDA this week, the first to Acorda Therapeutics on Tuesday.

SteadyMed submitted its application to the FDA in June, but the federal watchdog has requested more information on certain device specifications and performance testing, as well as additional design verification and validation testing.

The company said it plans to request a meeting with the FDA to better understand what it needs to resubmit its application.

“We believe that the issues raised in the letter from FDA can be sufficiently addressed. Our next step is to work with the FDA to address the open issues and identify a path to a successful resubmission and acceptance of our application,” president & CEO Jonathan Rigby said in prepared remarks. “We believe that Trevyent holds the potential to significantly improve the lives of patients suffering from PAH compared to the current standard of care, and remain committed to bringing the product to patients in need.”

The company’s product combines United Therapeutics‘ (NSDQ:UTHR) drug, Remodulin, with SteadyMed’s PatchPump infusion system for patients with pulmonary arterial hypertension.

See the best minds in medtech live at DeviceTalks Boston on Oct. 2. 

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dimecres, 30 d’agost del 2017

iCad wins Chinese approval for Xoft Axxent balloon applicators

iCad

iCad (NSDQ:ICAD) said today its Xoft Axxent balloon applicators have been cleared by the China Food & Drug Administration for treating early-stage breast cancer.

The Nashua, N.H.-based company’s Xoft Axxent balloon applicators are part of its Xoft Axxent electronic brachytherapy system designed to perform intraoperative radiation therapy in early-stage breast cancer patients who meet specific selection criteria.

The balloon applicator is used to deliver a single dose of radiation to the lumpectomy cavity to target cancer cells directly and limit exposure to health surrounding tissue, iCad said.

“The Xoft Axxent balloon applicators offer an attractive option for physicians and patients who desire improved flexibility, precision and personalization in the targeted treatment of early-stage breast cancer. We are pleased to continue working with iCAD in offering our customers access to the most advanced cancer treatments, including the complete portfolio of Xoft System products, in the years ahead,” iCad Chinese distributor Chindex Medical Limited COO Liu Yu said in a prepared statement.

With the clearance, iCad said that its complete suite of Xoft System products are cleared and available in China.

“A growing number of countries recognize the unique benefits the Xoft System offers to both patients and clinicians in treating a range of cancers. In 2015, more than 268,000 women in China were diagnosed with breast cancer, more than 69,000 women died of the disease, and the incidence has been rising rapidly in recent years.  Regulatory approval of Xoft Axxent balloon applicators in China represents a significant milestone in our continued efforts to bring this innovative, safe and clinically-proven treatment option to women worldwide with early-stage breast cancer,” CEO Ken Ferry said in a press release.

In February, iCad said it closed its sale of its VersaVue software and DynaCAD breast and prostate imaging devices to Royal Philips‘ (NYSE:PHG) Invivo unit for $3.2 million.

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Ethicon touts progress on multi-year bariatric surgery evidence initiative

Ethicon

Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon said today it has made major progress in its “Project Game Changer” initiative which looks to close evidence gaps and reduce clinical and economic barriers for access to surgical treatments for treating obesity and related diseases.

With the Game Changer Initiative, the company said it is focusing its research and evidence generation efforts on the safety and effectiveness of bariatric surgery on reducing obesity and obesity-related diseases, including type 2 diabetes, heart diseases and orthopedic conditions.

“A wide range of evidence guides innovation, adoption of procedures and everyday treatment decisions. We are committed to working with the bariatric community to advance the specialty and expand access for the benefit of patients everywhere. Significant progress has been made, but much work is left to do,” J&J innovation metabolic therapeutic area lead Dr. Elliott Fegelman said in a press release.

Ethicon said that several studies so far have been published as part of the initiative, with more underway.

“Groundbreaking clinical and economic studies, major treatment guidelines and real world evidence have contributed to the transformation of bariatric surgery from what was once considered by some to be either cosmetic or high risk to an effective lifesaving operation whose benefits go far beyond weight loss,” Ethicon company group chair Michael del Prado said in a prepared statement.

Earlier this month, Ethicon said it launched the ProxiSure laparoscopic suturing device.

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Vascular access device maker Stent Tek closes Series A

Stent Tek

Medical device firm Stent Tek said today it closed an undisclosed Series A financing round to support the development of its ePath AVF minimally invasive catheter technology.

The ePath AVF device is designed for vascular access as an alternative to surgical fistulas for hemodialysis patients.

Money in the round came from institutional investors Julz and Deepbridge Capital, the London-based company said.

Stent Tek has previously received $1.6 million (GBP £1.2 million) in grant funding from the National Institute of Health Research, Innovate UK and the Royal Academy of Engineering Enterprise Hub.

“I was thoroughly impressed of the discipline shown by the team and its proactive handling of issues that startups invariably face in developing medical devices that require high regulatory compliance. We are delighted to follow our initial seed investment and look forward to working with the Stent Tek team,” Deepbridge Capital’s Savvas Neophytou said in a prepared statement.

The company said it has validated the device’s core functionality in in-vivo models, and hopes to complete pre-clinical trials of the system by the 4th quarter of this year.

“We are delighted with the investment from Deepbridge Capital and Julz. They bring valuable knowledge, well-respected global networks and synergy to Stent Tek’s efforts to be the leading provider of a minimally invasive alternative to surgical fistulas for vascular access. With our combined experience and the investors’ valuable inputs into our strategic developmental efforts, Stent Tek will gain momentum in translating clinical advancements to market readiness,” co-founder and CEO Sorin Popa said in a press release.

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OR Software dev Explorer Surgical raises $3m

Explorer Surgical

Healthcare software dev Explorer Surgical said yesterday it closed an oversubscribed $3 million Series A financing round to support its intraoperative surgical and interventional procedure workflow management platform.

The round was led by Aphelion Capital and joined by Elliott Management, the University of Chicago, M25 Group and the Harvard Business School Angels of Chicago. As part of the financing round, Ned Scheetz, Anne Sissel, Immanuel Thangaraj and Kurt Azarbarzin will be joining the company’s board.

“Explorer Surgical has a successful track record since its formation at the University, and we are proud to support the team on behalf of the institution where it all began,” UChicago Startup Investment Program private equity investments head Joana Rupp said in prepared remarks.

“I’ve seen the traditional solutions for managing the OR fall short for years. The proliferation of new devices and tools adds additional layers of difficulty for surgical teams. As clinical protocols become more complex, it is critical to coordinate teams around best practices. Explorer has developed an elegant, tech-enabled platform with broad applicability. We are pleased to support their mission to improve quality and efficiency of the OR and interventional suites,” Aphelion Capital managing partner Ned Scheetz said in a prepared statement.

“Key stakeholders, including hospitals and medical device companies, are facing increasing pressures to reduce cost and improve the quality of care.  Explorer provides the leading platform and analytics solution to address these challenges and improve the efficiency, management and workflow of the OR,” Baxter ventures VP Anne Sissel said in a press release.

Explorer is developing a software-as-a-service tool which allows user to manage, track and analyze intra-operative activity and information for the operating room and interventional suites.

“For decades, the critical processes of surgery have been mapped out and managed on paper, and we are ready to change the game with our digital, real-time platform and analytics solution. The investor syndicate and board of directors have an impressive track record in building medical technology companies that will be instrumental to our growth strategy. We are thrilled to have continued support from those who have successfully innovated in the surgical space for decades,” CEO Jennifer Fried said in a prepared release.

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Medrobotics touts 1st colorectal procedure with Flex robotic system

Medrobotics

Medrobotics said today that its Flex robotic system was used in its 1st colorectal surgery, touting it as a global 1st for the system.

The surgery was performed at George Washington University Hospital by Dr. Vincent Obias, the company said, to remove a suspected cancerous lesion from the rectum of an adult male. The procedure required no incisions through the skin, the Raynham Mass.-based company said.

“The Flex Robotic System is the first robotic platform that allows surgeons to visualize and access lesions in the rectum with a steerable and shapeable robotic scope and flexible instruments. This offers some patients the opportunity to be treated with fewer incisions and may result in reduced complications and faster recoveries,” Dr. Obias said in a press release.

“Until now, robotic-assisted colorectal surgery required multiple incisions through the abdomen because straight, rigid robotic tools were not designed to navigate the twists and turns of the human gastrointestinal system. These procedures can result in complications, pain and scarring. The Flex robotic system was designed to enable Scarfree robotic-assisted access to cancer and other lesions in the rectum and distal colon, following a path directly through the anus,” prez & CEO Samuel Straface

In May, Medrobotics won indications for colorectal procedures with the Flex system from the FDA, and won similar expanded CE Mark approval in the European Union last October.

The system won 510(k) clearance from the FDA for transoral procedures in July 2015 (that indication won CE Mark approval back in March 2014). Medrobotics bills itself as the 1st robotics firm to offer minimally invasive and steerable robotic products for colorectal applications.

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Abbott launches Amplatzer newborn congenital heart defect trial

Abbott logo

Abbott (NYSE:ABT) said today it launched a US pivotal trial looking to explore the safety and effectiveness of a modified version of its Amplatzer device designed to correct patent ductus arteriosus, a congenital heart defect in pre-term infants.

“Patent ductus arteriosus is one of the most common heart defects, accounting for 5% to 10% of all congenital heart disease. Surgery has many risks in this delicate population and a minimally invasive approach is desperately needed,” principal investigator Dr. Evan Zahn of Los Angeles’ Cedars-Sinai Heart Institute said in a prepared statement.

Patent ductus arteriosus is a life-threatening vascular pathway or duct in the heart that remains open due to a failure in the fetal duct to close after birth, Abbott said. The duct serves as a bridge between blood vessels and is located between the main 2 arteries existing the heart, and normally seals itself after birth. In particular cases, the PDA fails to close and can result in serious difficulty breathing and inability to feed.

Abbott said it is developing a version of the Amplatzer device, which has already been approved in Europe, to provide a nonsurgical treatment option for closing PDA defects in newborns and pre-term infants. The device is a wire mesh placed non-surgically through a catheter, inserted through the leg and guided through the vessels to the heart, to seal the duct.

“This modified Amplatzer device has been designed with our youngest and tiniest patients in mind. These smaller sizes may offer physicians greater flexibility to hopefully help these infants live healthy, normal lives,” Abbott structural heart biz VP Michael Dale said in a press release.

The study is slated to enroll approximately 50 patients at 10 centers in the US, with the 1st 7 patients already enrolled at Memphis, Tenn.’s Le Bonheur Children’s Hospital, treated by Dr. Shyam Sathanandam, Abbott said.

The company said it is hopeful that trial results will support an eventual FDA submission for approval.

Yesterday, Abbott said it is upgrading the implantable pacemakers and defibrillators it acquired when it paid $25 billion for St. Jude Medical earlier this year, seeking to move beyond battery and cybersecurity issues that haver plagued it for a year.

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MassDevice.com +5 | The top 5 medtech stories for August 30, 2017

plus5-node

Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.

Get this in your inbox everyday by subscribing to our newsletters.

 

5. CSP Technologies expands Alabama facility

MassDevice.com news

CSP Technologies is expanding its Auburn, Ala. manufacturing and warehousing capacity by 110,000 sq. ft. The expansion has already begun and is under construction.

The company said in a recent news release that it is expanding its facility because of the growing needs of the healthcare and food safety industries. The expansion follows a thermoforming line that was released earlier this year. Read more


4. Vascular Dynamics touts significant BP reductions in interim MobiusHD trial results

MassDevice.com news

Vascular Dynamics yesterday released interim results from the 1st-in-human trial of its MobiusHD implant designed for treating resistant hypertension, touting significant reductions in ambulatory systolic blood pressure.

Results were released at the European Society of Cardiology’s annual meeting in Barcelona. Read more


3. Most FDA user fees set to rise 33%

MassDevice.com news

The latest user fee authorization enacted last week has most of the fees medical device makers pay the FDA to review its products rising by more than 33%, with the fee for one popular protocol jumping more than 125%.

All but one of the user fees for fiscal 2018, which begins Oct. 1, are going up 32.5% compared with the fiscal 2017 fees for both small businesses making less that $100 million annually and for their larger brethren, according to the FDA’s Center for Devices & Radiological Health. Read more


2. Abbott upgrades St. Jude Medical cardiac devices

MassDevice.com news

Abbott said today that it’s upgrading the implantable pacemakers and defibrillators it acquired when it paid $25 billion for St. Jude Medical earlier this year, seeking to move beyond battery and cybersecurity issues that haver plagued it for a year.

Last October St. Jude warned of a battery issue that could disable its high-voltage cardiac rhythm management devices, saying the problem was associated with 2 deaths among the nearly 400,000 patients implanted with affected devices. The issue stemmed from the formation of lithium clusters in the lithium-based batteries used in the devices that can form during high-voltage charging. The clusters could then cause a short circuit and deplete the battery within a day to a few weeks, rendering the device incapable of delivering therapy. Read more


1. Medtronic puts another $40m into Mazor Robotics

MassDevice.com news

Mazor Robotics said today that it’s accelerating a deal with Medtronic, which is due to put another $40 million into Mazor and take on exclusive global distribution rights for the Mazor X robot-assisted surgery device.

It’s the third investment in the Israeli surgical robotics concern for Fridley, Minn.-based Medtronic, taking its total investment to $72 million and a 10.6% stake in Mazor. The deal also includes 1.21 million warrants priced at $44.23 apiece; if exercised in full Medtronic would own a 14.2% stake in Mazor, having invested some $125 million. Read more

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This exoskeleton could eliminate crouch gait

robotic exoskeletonThe National Institutes of Health has created what it claims is the first robotic exoskeleton that is designed to treat crouch gait in children who have cerebral palsy.

Crouch gait occurs when there is excessive bending of the knees while walking. It is a common condition in children with cerebral palsy. The NIH reports that even with conventional treatments, crouch gait can develop into the degeneration of walking function and eventually the loss of walking ability in about half of adults with the disorder.

NIH Clinical Center researchers tested a prototype of the exoskeleton to determine if the motors were safe and effective for reducing crouch gait and evaluate its effects on voluntary muscle activity. The exoskeleton offers powered knee extension assistance during key point while walking.

Get the full story on our sister site, Medical Design & Outsourcing.

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Globus Medical lifts Demski to CEO, former head Paul to say on as exec chair | Personnel Moves August 30, 2017

Globus Medical new CEO David Demski

Globus Medical (NYSE:GMED) said yesterday that it named David Demski as its new chief executive officer, effective immediately, replacing David Paul who is stepping down due to health issues but will stay on as executive chairman.

Demski has served as a Globus senior executive since 2003 and operated as CFO from 2003 to 2008, moving to the role of prez and COO afterwards. In 2015, Demski was promoted to president of emerging technologies, overseeing expansions into imaging, navigation, robotics and orthopedic trauma, the company said.

“No one is or could be more well suited to be CEO of Globus Medical than Dave. He has been with us since the very start of this company, has led virtually every aspect of its operations, and has been a significant contributor to the company’s success to date. During the 7 years when Dave served as president, among his many responsibilities were direct leadership of both our domestic and international sales forces. During that time, and as he took over responsibility for our emerging technologies division, Dave honed a talent for optimizing sales team performance and developing and commercializing new products. His skill set is precisely what we need to continue our focus on profitable growth. With Dave taking over day-to-day management of the company, I can focus on the things I am most passionate about and the areas in which I can bring the most value to our shareholders: strategy and technology innovation. Globus Medical was built on delivering groundbreaking solutions to surgeons and their patients, and we will not stray from our core mission.  We have built a strong company and will move forward with the same vision and passion for which we are known. I look forward to being part of the company’s continued success,” Paul said in a press release.

Paul will stay on to focus on strategic initiatives, Globus said, and will take time to recover from an unnamed health condition. He is expected to recover over the next several months, and the company said he will remain “actively involved” during his recover and thereafter.

The move, while unexpected, isn’t a net negative, according to Leerink Partner analyst Richard Newitter.

“We don’t think this CEO transition signals any risk of the company’s rev growth re-acceleration story (or sustainability of above-average profit margins),” Newitter wrote in a letter to investors.

The company reiterated its guidance for the full year, Newitter said, and coupled with the fact that Demski is a seasoned internal GMED exec, makes the move neutral to the company’s outlook.

 Abiomed CFO Tomsicek steps away

Abiomed (NSDQ:ABMD) said this week its chief financial officer Michael Tomsicek has stepped away from the company to pursue other interests.

The Danvers, Mass.-based company said it is engaging in a search for a replacement, with former CFO Robert Brown returning from retirement as a consultant until a new CFO has been recruited and hired. Brown served as Abiomed’s CFO from Dec. 2008 to July 2015.

“We wish Mike Tomsicek all the best as he explores other opportunities and thank him for maintaining high standards of financial compliance and quality. We also welcome back Bob Bowen, who has been instrumental to Abiomed’s success over nearly the last decade,” prez & CEO Michael Minogue said in a press release.

Abiomed said that VP and corporate controller Ian McLeod will serve as principal financial officer and principal accounting officer on an interim basis until a permanent replacement has been hired.

Read more

 CHF Solutions adds 6 to sales team

CHF Solutions (NSDQ: CHFS) said yesterday it added 6 sales reps to its commercial sales organization as it looks to meet customer demand.

The Eden Prairie, Minn.-based company said that the new representatives joined from “top tiered medical device organizations,” and that the newly hired individuals will focus on enhancing existing account penetraiton and new business development.

“We are excited to continue our sales team expansion with the onboarding of 6 new, deeply experienced sales representatives who will aid in the accomplishment of our growth goals. We have established a comprehensive sales training program to optimize time to productivity for our new sales representatives in support of our commercial strategy,” chair & CEO John Erb said in a prepared statement.

Read more

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FDA clears Danaher’s Leica Microsystem’s FL560 cerebrovascular fluorescence microscope filter

Leica Microsystems

Danaher‘s (NYSE:DHR) Leica Microsystems said yesterday it won FDA 510(k) clearance for its FL560 fluorescence microscope filter designed for visualizing cerebrovascular blood flow when used in conjunction with dye fluorescein.

The filter is designed to be integrated into a M530 OH6 neurosurgical microscope to provide real-time, high-contrast visualization of cerebral anatomy in native color and fluorescent blood flow, the Germany-based company said.

Leica said that the integration of the filter allows for a high-contrast image with clearly visible anatomy, with even the smallest vessels delineated.

“Leica Microsystems has been a leader in advanced surgical visualization for decades. We have achieved a number of ‘1sts’ over the years including the first FDA 510(k) clearance of a microscope for intra-operative angiography and the first company offering a surgical microscope to integrate three types of fluorescence capabilities. I am proud that our team again was able to be the innovation leader by being the first company to achieve FDA clearance for cerebrovascular fluorescence imaging with fluorescein. This demonstrates our commitment to deliver clinically relevant and validated solutions to clinicians that allow them to make crucial surgical decisions and as a result improve patient outcomes,” prez Markus Lusser said in a prepared statement.

Last September, Danaher said it would buy molecular diagnostics company Cepheid in a deal valued at $4 billion, including debt, as it looked to strengthen its diagnostics business.

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Insulet breaks ground on new manufacturing plant in Mass.

InsuletInsulet (NSDQ:PODD) reportedly broke ground on a new manufacturing facility on a site it bought earlier this year in Acton, Mass.

The $100 million, 350,000-square foot plant is being built on a 26-acre lot Billerica, Mass.-based Insulet acquired for $9.3 million in February, according to the Worcester Business Journal.

Insulet uses a quarter of contract manufacturers to make its flagship OmniPod insulin management system, but plans to transition to a more modern operation once the new plant goes on line, expected in 2019. The heavily automated Acton facility is designed to produce up to 70% more devices with up to 90% fewer employees, compared to all four of its Chinese partners, Insulet has said.

The new facility is expected to add hundreds of jobs in Massachusetts over the next 5 years, according to the company.

Last October, Leerink Partners analysts said that drug-delivery business will be a long-term growth driver for Insulet by as much as 20% per year for the next few years.

Insulet generates 86% of its revenue from its OmniPod insulin delivery device, according to Leerink. The OmniPod technology could be easily adapted to other drugs, according to the investment bank, which cited Insulet’s partnership with Amgen (NSDQ:AMGN) as a foundation for other wearable drug-delivery products.

Residents of Acton voted in April to approve zoning changes to the new site, expanding the facility from 300,000 square feet to 350,000 square feet. Insulet said it plans to break ground in June, according to the Boston Business Journal

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CSP Technologies expands Alabama facility

2017 Facility Expansion - Long viewCSP Technologies is expanding its Auburn, Ala. manufacturing and warehousing capacity by 110,000 sq. ft. The expansion has already begun and is under construction.

The company said in a recent news release that it is expanding its facility because of the growing needs of the healthcare and food safety industries. The expansion follows a thermoforming line that was released earlier this year.

CSP Technologies’s thermoforming operations will be pivotal to its new portfolio of antimicrobial products for food safety, according to the company.

Get the full story on our sister site, Medical Design & Outsourcing.

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Giving your studies a FAIR shake

imarcI was talking with a professional colleague recently, who referenced IMARC Research’s FAIR Shake™ method as a tool she uses regularly in her clinical research activities.  It prompted me to feature our whitepaper on the FAIR Shake™ training program.  Even though it is one of our older papers, it is still a useful tool for clinical research professionals.  This technique helps you bridge the gap between knowledge and application.

The goal of this white paper is to introduce you to the concept of the FAIR Shake™ in an effort to foster a pattern of thinking that will allow you to navigate through the complexity of the regulatory framework in a very simple way that is based in regulatory fact as opposed to popular opinion.

The FAIR Shake™ technique takes an otherwise complicated maze of requirements and breaks them down into four simple areas that can be applied to clinical research questions.  Using this technique will position you to raise the bar on your own study teams as you gain confidence in your ability to wage an educated debate when potential areas of non-compliance are raised.

Once you learn the FAIR Shake™ technique, you’ll become accustomed to asking yourself if it’s in the Regs…or is it?  Simply by giving your studies a FAIR Shake™!  

Let us know if you think this technique is of value.

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The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

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Exthera Medical wins FDA EAP designation for Seraph 100 blood filter

Exthera Medical

Exthera Medical said today that the FDA granted its Seraph 100 blood filter an expedited access pathway designation.

The approval comes with an initial indication for use “as an adjunctive treatment for bacteremia in addition to antibiotics for patients receiving hemodialysis when the source of the infection is heparin- or heparin sulfate-binding bacteria, including antibiotic resistant bacteria MRSA, VRE, ESBL, CRE and MRSE,” the company said.

“We submitted our EAP application in early June. FDA responded by requesting additional information and clarifications, and Seraph was granted EAP designation within the accelerated timeframe FDA set for itself. The support we received from FDA was very helpful,” COO Kathleen White said in a press release.

The company’s Seraph microbind affinity blood filter is designed to remove a range of sepsis-causing bacteria, viruses, toxins and pro-inflammatory cytokines from blood.

Exthera said that the Seraph varies from other blood filters as it removes a variety of different pathogens simultaneously by using a blood-contacting surface which does not injure blood.

“The EAP designation for Seraph gives us the opportunity to accelerate the approval process in the United States while still maintaining the high standards of safety, efficacy and scientific rigor required by the program.  It has been said that ‘Speed is life’ in the effective treatment of blood stream infections. Seraph can potentially save thousands of lives now lost to infections for which there are no available drugs. ExThera Medical is focused on developing simple devices for the rapid treatment of bloodstream infections, especially in the face of rising incidence rates and the worldwide spread of drug-resistant pathogens. Effective treatments for potentially lethal BSIs are also needed for members of our military for whom the risk of exposure is significant,” CEO & prez Dr. Robert Ward said in a prepared statement.

Last June, Exthera said it raised a $15.3 million Series B round following positive tests of its CE-Marked Seraph blood filter in animal studies.

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Siemens, ISA ink industrial, automation cybersecurity deal

Siemens, ISA

Siemens (NYSE:SI) said today it inked a global partnership deal with the International Society of Automation to improve awareness of industrial cybersecurity needs.

Through the deal, both parties will cooperate to improve industrial cybersecurity and automation security, based on IEC 62443 standards and appropriate security measures, as well as engaging in educational activities.

The ISA’s Security Compliance Institute operates 1 of the 1st standardized assessment schemes for the IEC 62443 IACS cybersecurity standards, which has been adopted by Siemens for its automation equipment and industrial security services, the companies said.

Siemens said it adheres to the IEC 62443 guidelines, and provides a comprehensive Product Computer Emergency Response Team for its solutions and equipment in addition to running several “Cyber Security Operation Centers” for production and industrial facilities.

“Cyber Security needs to be addressed by industrial companies as recent global ransomware attacks have demonstrated the possible impacts in the last weeks. Our customers need to adequately manage the associated cyber risk, arising from the vulnerabilities of IT technology combined with the increased connectedness in our digital age,” Siemens plant security services global head Henning Rudolf said in a press release.

Earlier this month, Siemens said it inked a multi-year deal with Houston Methodist Hospital to integrate its imaging technologies into the Houston Methodist’s facilities and engage in joint research & development

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Most FDA user fees set to rise 33%

FDAThe latest user fee authorization enacted last week has most of the fees medical device makers pay the FDA to review its products rising by more than 33%, with the fee for one popular protocol jumping more than 125%.

All but one of the user fees for fiscal 2018, which begins Oct. 1, are going up 32.5% compared with the fiscal 2017 fees for both small businesses making less that $100 million annually and for their larger brethren, according to the FDA’s Center for Devices & Radiological Health.

But the fee for 510(k) clearance, the safety watchdog’s most common form of medical device review, jumped 125.3% to $10,566.

The agency cut the fees by -2.9% for fiscal 2015, having raised them by 4.2% for FY2014.

Here’s how this year’s changes break down:

Application type Fee for FY18 Fee for FY17 % change Small business fee FY18 Small business fee FY17 % change
510(k) premarket notification submission $10,566 $4,690 125.3% $2,642 $2,345 32.5%
513(g) request for classification information $4,195 $3,166 32.5% $2,098 $1,583 32.5%
PMA, PDP, PMR, BLA $310,764 $234,495 32.5% $77,691 $58,624  32.5%
Panel-track supplement $233,073 $175,871 32.5% $58,268 $43,968 32.5%
180-day supplement $46,615 $35,174 32.5% $11,654 $8,794 32.5%
Real-time supplement $21,753 $16,415 32.5% $5,438 $4,104 32.5%
Annual fee for periodic Class III reporting $10,877 $8,207 32.5% $2,719 $2,052 32.5%
30-day notice $4,972 $3,752 32.5% $2,486 $1,876 32.5%

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FDA clarifies Early Feasibility Study program for innovative medical devices

Emergo GroupBy Stewart Eisenhart, Emergo Group

The US Food and Drug Administration has published new information online explaining how medical device manufacturers may apply and qualify for limited-scope clinical investigations known as Early Feasibility Studies (EFS).

Get the full story here at the Emergo Group’s blog.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

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Medtronic puts another $40m into Mazor Robotics

Mazor Robotics, MedtronicMazor Robotics (NSDQ:MZOR) said today that it’s accelerating a deal with Medtronic (NYSE:MDT), which is due to put another $40 million into Mazor and take on exclusive global distribution rights for the Mazor X robot-assisted surgery device.

It’s the third investment in the Israeli surgical robotics concern for Fridley, Minn.-based Medtronic, taking its total investment to $72 million and a 10.6% stake in Mazor. The deal also includes 1.21 million warrants priced at $44.23 apiece; if exercised in full Medtronic would own a 14.2% stake in Mazor, having invested some $125 million.

A year ago Medtronic paid $20 million for a 3.4% stake as part of a two-stage deal struck in May of that year. The first phase of the deal called for Medtronic to acquire 15 Mazor systems in 2016 and made Medtronic Mazor’s sole partner for developing and commercializing robot-assisted spine surgery devices. The second phase called for a three-step equity investment; after the second step, triggered by the launch of the Mazor X system in July 2016, Medtronic had spent $31.9 million acquiring a 7.27% stake in Mazor.

The new terms of the deal set annual minimum Mazor X purchases that could mean hundreds of the systems over a four-and-a-half-year period and place about 30 Mazor sales reps under the Medtronic umbrella “to assure continuation of the current momentum,” Mazor said, noting that it will continue to service the installed base of Mazor X platforms.

Apart from shoring up the balance sheet, the deal is expected to slash Mazor’s annual operating expenses by $13 million, or about -25%, the company said.

“Medtronic is our valued strategic partner and together we have achieved the desired outcome for Phase I well ahead of our original plan,” Mazor CEO Ori Hadomi said in prepared remarks. “I believe that the move to this next phase reinforces our significant leadership position in the growing market for surgical guidance systems for spine procedures. Our strategic partnership will allow hospitals in new markets around the world to have access to the Mazor X and gain the clinical benefits that this technology offers.

“The strategic partnership between Mazor and Medtronic has already resulted in 59 Mazor X system orders since the October 2016 launch and reflects an accelerated sales cycle due to customers’ eagerness to adopt our solutions for the spine market,” Hadomi said. “Now, as commercial responsibility for the Mazor X in the spine market shifts to Medtronic, the annual minimums for sale of Mazor X systems agreed to by the two companies are expected to drive substantial improvement in Mazor’s financial results during the next several years. Together we will be able to further advance our robust jointly-developed product pipeline for the spine market, to make a difference for patients while Mazor also pursues new opportunities to apply our innovative technologies to other medical needs.”

“Moving to the next phase of our strategic partnership demonstrates our shared passion for transforming how spine surgery is done,” added Medtronic Spine president Doug King. “Mazor Robotics’ technology and Medtronic’s navigation capabilities and implant systems provide spine surgeons with complete procedural solutions that advance the standard of care and will help surgeons maximize predictability and efficiency.”

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Vascular Dynamics touts significant BP reductions in interim MobiusHD trial results

Vascular Dynamics

Vascular Dynamics yesterday released interim results from the 1st-in-human trial of its MobiusHD implant designed for treating resistant hypertension, touting significant reductions in ambulatory systolic blood pressure.

Results were released at the European Society of Cardiology’s annual meeting in Barcelona.

The MobiusHD device is designed to help regulate blood pressure using electrodes implanted in the carotid artery to stimulate baroreceptors and increase the body’s natural response to lower blood pressure through vasodilation.

Data in the interim study came from the 1st 40 patients to reach the 6-month endpoint, indicating that 88% of the cohort had a greater than 10 mmHg drop in systolic blood pressure or 5 mmHg or more in 24-hour ambulatory systolic blood pressure. The average reduction of ambulatory systolic blood pressure was reported at 20 mmHg, the company said.

Interim results will be followed by a study which is slated to be published in The Lancet next month, Vascular Dynamics said.

“These interim data show significant promise in treating patients with resistant hypertension, that is, those who remain uncontrolled even after as many as three or more antihypertensive drugs. Our positive experience with the MobiusHD device demonstrates the need for continued investigation in a sham-controlled setting, which is currently running in the Netherlands and is starting up in the United States, United Kingdom, and Germany shortly,” trial investigator Dr. Wilko Spiering of the Netherlands’ University Medical Center Utrecht said in a press release.

Earlier this month, Vascular Dynamics said the FDA approved an investigational device exemption for a clinical trial of its MobiusHD device for treating resistant hypertension.

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Medovex shares rise on Australian nod for DenerveX system

Medovex's DenerveX

Medovex shares rose slightly today after the company announced it won regulatory approval from the Australian Therapeutic Goods Administration for its DenerveX system.

The DenerveX system uses a slowly rotating burr to remove targeted facet joint synovial membrane and radiofrequency ablation technology to destroy tissue and denude any residual nervous and synovial membrane on the joint, effectively removing sensory tissue from it, the Atlanta-based company said.

The approval is the 1st in the Asia Pacific region, Medovex said, and came ahead of its expected approval. The company said it is slated to conduct sales and product training with its Australian distributor on Sept. 17, with initial procedures anticipated for shortly after.

“We’re clearly very pleased to have received regulatory approval ahead of schedule for the marketing and sale of our DenerveX Device in Australia. This paves the way for entry into a very important area globally, Asia Pacific. Australia is a highly regarded market by many in the global medical community for the quality of care and delivery of the latest technology for the treatment of chronic disease such as facet joint pain. Since announcing receipt of CE Mark in less than just 3 months ago, we have now received orders which include countries from 3 continents, the EU, Latin America and now Asia Pacific,” prez & COO Patrick Kullmann said in a press release.

Shares in Medovex rose 1.7% today, closing at $1.17.

In July, Medovex said it sold its 1st DenerveX system, and that the device had been used in its 1st commercial procedures since winning CE Mark approval in the European Union a month prior.

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MicroPort Orthopedics launches Procotyl Prime hip system

MicroPort

MicroPort Orthopedics said today it launched its Procotyl Prime acetabular cup system.

The Arlington, Tenn.-based company won FDA 510(k) clearance for the system in late June, and said that the system is the next step in the evolution of its Dynasty acetabular cup system.

“At MicroPort Orthopedics, we embrace the constant advance in orthopedic medicine, and have a deep commitment to creating products that make patients’ lives better. The Procotyl Prime acetabular cup system, with its best-in-class features, is a great example of this commitment, as it not only strengthens our position as a leader in surgical joint replacement, but also complements our existing products and surgical approaches to help patients return to full function faster,” prez Aurelio Sahagun said in a press release.

MicroPort Orthopedics touted the Procotyl Prime as the 1st on the market with simple, versatile instrumentation to support a number of surgical approaches.

“Procotyl Prime’s design is a culmination of over 20 years of market experience coupled with intelligent design and engineering. We set out to design an implant optimized for highly-crosslinked polyethylene and modern 3D fixation surfaces, allowing us to eliminate compromises. The result is a shell that is strong and flexible, has maximized poly thickness and robust pull-out strength, all while allowing the versatility of large head options in the smallest sizes,” Dr. James Chow of the Phoenix St. Luke’s Medical Center said in a prepared statement.

“Procotyl Prime is the first acetabular component adapted for MicroPort’s novel portal-assisted acetabular instrumentation. This unique approach facilitates preservation of soft tissue, fast patient recovery, and direct acetabular visualization,” Dr. Brad Penenberg of Cedars-Sinai Hospital said in a prepared release.

In February, MicroPort released the results from a study of its Medial-Pivot knee system, touting high rates of satisfaction and survivorship at 17 years.

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Noble partners with BD to develop patient onboarding services

Noble, Becton Dickinson

Biopharma group Noble said today it inked a collaborative deal with Becton Dickinson & Co. (NYSE:BDX) to develop patient onboarding services including demonstration devices.

Through the deal, Noble said it will develop novel demonstrators based on BD’s UltraSafe technology to improve access to new services for pharma partners, supporting product launches and patient experiences.

The companies said the combination of Noble’s market research and BD’s passive needle stick safety devices will allow for fully customized drug delivery devices with access to dedicated onboarding systems in one location.

“Demonstration devices can be instrumental in helping patients overcome fear and anxiety when using an injectable drug delivery device. However, our research has shown that for onboarding to be successful, the demonstrating device must be meticulously engineered to mimic the exact look and feel of the actual drug delivery device. In a recent market survey, we found that 89% of patients reported it’s very important to have the most realistic demonstrating device possible. By having a deep understanding of complex device engineering and patient needs, we can better help our partners like BD create impactful onboarding solutions,” Noble exec VP Craig Baker said in a prepared statement.

Noble said that all demonstrators are tested to guarantee needle simulation and plunger speeds to mimic real drug delivery devices.

“This collaboration represents the latest commitment to our ongoing expansion of the BD UltraSafe Needle Guard portfolio, as BD continues to increase the capabilities of the platform within the injectable biopharmaceutical market. With the increased use of the BD UltraSafe Passive and BD UltraSafe Plus Passive Needle Guards by patients who self-inject doctor prescribed medications, there is a need to provide a solution to our pharmaceutical partners to support patient onboarding. Noble’s systems deliver a viable option that leverages strong expertise for patients and broadens BD’s overall offering in demonstration devices,” BD safety & shielding systems VP Patrick Jeukenne said in a press release.

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MassDevice.com +5 | The top 5 medtech stories for August 29, 2017

plus5-node

Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.

Get this in your inbox everyday by subscribing to our newsletters.

 

5. Why medtech should keep its lobbying expectations low in 2017

MassDevice.com news

Political chaos is lowering expectations when it comes to the medtech industry getting much done in Congress this year, says Clayton Hall, VP of government affairs for the Medical Device Manufacturers Association.

When it comes to permanent repeal of the 2.3% medical device excise tax that was part of the 2010 Affordable Care Act, there are fewer legislative opportunities, Hall said during a webinar hosted Aug. 23 by Medmarc Insurance Group. Read more


4. Report: Chinese medical device market growing faster than pharma

MassDevice.com news

The medical device industry in China is experiencing rapid growth when compared to the global medtech market, as well as its pharmaceuticals industry, according to a report from China Med Device.

Between 2005 and 2015, the medical device market in China hit an annual growth rate of greater than 20%, according to the report, with demand for medical devices “expected to increase significantly.” Read more


3. NuVasive unveils new San Diego HQ expansion

MassDevice.com news

NuVasive Inc. today unveiled the planned expansion of its San Diego headquarters to include an “innovation center of excellence,” slated to break ground in January 2018.

The 100,000-square-foot expansion will bring the facility’s total HQ spread to 250,000 square feet, NuVasive said, noting its commitment to boosting its R&D spend from 5% to 7% “over the next several years.” Read more


2. BD extends Bard tender again

MassDevice.com news

Becton Dickinson & Co. once again extended its tender offer for up to $1.1 billion in outstanding C. R. Bard notes from August 29 to Sept. 27 ahead of their $24 billion merger.

The $317-per-share deal, announced last April, is expected to close during the fourth quarter. Bard shareholders approved the transaction earlier this month. BD is offering to buy up roughly $500 million in 4.4% Bard notes due 2021, $500 million in 3% notes and $149.8 million in 6.7% notes, both due 2026. Read more


1. InVivo retools to get Inspire trial back on track, lays off 39%

MassDevice.com news

InVivo Therapeutics said yesterday that it’s laying off nearly 40% of its workforce, pausing a clinical trial and cutting two R&D programs as it tries to get its a pivotal study back on track.

The Cambridge, Mass.-based company, which is developing a scaffold implant to treat traumatic spinal cord injuries, last month suspended its 16-patient Inspire study after its most recent patient passed away suddenly following hospital discharge. Although the death was found to be unrelated to the InVivo scaffold or its implantation procedure, the company temporarily halted enrollment to discuss potential changes to Inspire’s enrollment criteria with the FDA. Read more

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Nemaura develops medical grade diabetes management app

Nemaura MedicalNemaura Medical (OTC:NMRD) said today that it has finished development of a medical grade app designed to be used with the company’s SugarBeat continuous glucose monitoring system or with glucose meters.

The mobile app, which was developed for android mobile devices, allows users to input their diet, medication and exercise information, as well as view glucose trends.

Get the full story at our sister site, Drug Delivery Business News.

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Abbott upgrades St. Jude Medical cardiac devices

Abbott logoAbbott (NYSE:ABT) said today that it’s upgrading the implantable pacemakers and defibrillators it acquired when it paid $25 billion for St. Jude Medical earlier this year, seeking to move beyond battery and cybersecurity issues that haver plagued it for a year.

Last October St. Jude warned of a battery issue that could disable its high-voltage cardiac rhythm management devices, saying the problem was associated with 2 deaths among the nearly 400,000 patients implanted with affected devices. The issue stemmed from the formation of lithium clusters in the lithium-based batteries used in the devices that can form during high-voltage charging. The clusters could then cause a short circuit and deplete the battery within a day to a few weeks, rendering the device incapable of delivering therapy.

That news followed a short-seller-fueled scandal about alleged cybersecurity vulnerabilities in the St. Jude devices. Short-selling firm Muddy Waters and a cybersecurity firm in August 2016 alleged that major flaws in the CRM devices exposed them to a cybersecurity risk, but only after taking short positions on STJ’s stock. St. Jude later sued Muddy Waters and the hacking shop behind the report, after the sides traded accusations about its accuracy (which independent researchers found had “major flaws” – but not before STJ shares lost about 5% of their value).

Today Abbott said it’s upgrading its ICDs with a battery performance alert and plans to update its pacemakers’ firmware with additional cybersecurity measures to prevent unauthorized access. Abbott stressed that there have been no reports of unauthorized access to any patient’s implanted device.

“Connected devices are having a significant positive impact for patients and their health,” medical devices executive vice president Robert Ford said in prepared remarks. “To further protect our patients, Abbott has developed new firmware with additional security measures that can be installed on our pacemakers.

“All industries need to be constantly vigilant against unauthorized access,” Ford said. “This isn’t a static process, which is why we’re working with others in the healthcare sector to ensure we’re proactively addressing common topics to further advance the security of devices and systems.”

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Acorda shares plunge -30% after FDA refuses to review NDA

Acorda TherapeuticsShares in Acorda Therapeutics (NSDQ:ACOR) dropped nearly -30% today after the FDA told the company that the new drug application for its inhaled Parkinson’s disease treatment is incomplete.

The FDA’s refusal to file letter surprised analysts. The note from the regulatory agency had to do with the date when the manufacturing site would be ready for inspection and a question about the submission of the drug master production record, Acorda said.

Get the full story at our sister site, Drug Delivery Business News.

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Boston Scientific, J&J win Pentagon award for supporting employed service members

Boston Scientific, Johnson & Johnson

Boston Scientific (NYSE:BSX) and Johnson & Johnson (NYSE:JNJ) were awarded last week with the Secretary of Defense Employer Support Freedom Award for the companies’ support of employees in the military reserves and National Guard

The award was delivered to 15 companies out of 3,064 nominations, according to the Freedom Award’s website, and marks the “highest honor given to employers for support of National Guard and Reserve employees.”

Other companies that received the award included Cargill and Comcast NBC Universal according to the site.

Marlborough, Mass.-based Boston Scientific CEO Mike Mahoney attended the ceremony, held at the Pentagon in Washington D.C., to receive the award, according to a Boston Business Journal report.

“As a global medical technology company, we value the leadership, courage and skills that our service employees develop in the military. We are extremely proud of them and applaud their service to our country, our communities and our company – they are an inspiration to us all,” CEO Mahoney said, according to the report.

Boston Scientific reported that it provides full salary to employees during their 1st 30 days of military leave, followed by a paid differential pay for the remainder – up to 5 years of cumulative deployment time, the BBJ reports.

“We really do, here in the Pentagon, do our best to take care and provide for our men and women but you and your organizations go the extra mile and you make our jobs easier. Here in the Pentagon we say leadership casts a long shadow. Your shadow is long. Your employees see it. The communities you operate in see it, and it manifests itself at this level as the will of the nation,” Deputy Defense Secretary Pat Shanahan said, according to a Department of Defense release.

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