dilluns, 30 de novembre del 2015

FDA: Class II recall for Medtronic’s InSync III pacemakers

MedtronicA battery longevity issue prompted Medtronic this month warn doctors about some 96,787 of its InSync III pacemakers, an action the FDA labeled a Class II recall, although Medtronic said only about 22,000 of the devices are still active.

The Fridley, Minn.-based medical device titan sent a letter to physicians dated November 2015, warning that a high battery impedance issue “can result in the battery’s inability to supply sufficient electrical current.” Through Oct. 27, 30 devices of 0.03% were confirmed to have experienced the issue, Medtronic said, noting that it’s impossible to predict which of the InSync II devices, which are no longer distributed, might be affected by the battery problem.

“Twelve (12) of the 30 devices had reports of unexpected loss of pacing capture. The other 18 devices experienced some form of erratic behavior, including early elective replacement indication (ERI), significant fluctuations in remaining longevity estimates, and inaccurate lead impedances. Through 27 October 2015, events associated with this issue have occurred in devices with implant durations of 53 months or more. Medtronic has received 1 report of a patient death, where it is possible, but unconfirmed, that this issue was a contributing factor,” the company said in the letter.

“Our modeling predicts an estimated failure rate between 0.16% and 0.6% for the remaining active devices,” Medtronic said.

The company recommended no action be taken for InSync III patients who are not dependent on their pacemakers.

“For pacemaker-dependent patients, physicians should carefully weigh the risks and benefits of device replacement to mitigate this issue on an individual patient basis,” Medtronic said. “The estimated per patient mortality risk of this issue (0.007% to 0.02%) is comparable to the estimated per patient mortality risk of complications associated with an incremental, early device replacement (0.005%).”

A Class II recall denotes the risk of “temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”

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MassDevice.com +3 | The top 3 medtech stories for November 30, 2015

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Say hello to MassDevice +3, a bite-sized view of the top three medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 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.

 

3. Jury hits Wright Medical with $11m verdict in Conserve hip implant bellwether

MassDevice.com news

A federal jury in Georgia handed an $11 million loss to Wright Medical in the 1st bellwether trial in the multidistrict litigation filed over its Conserve metal-on-metal hip implant.

The Atlanta jury awarded plaintiff Robyn Christiansen $1 million in compensatory damages and another $10 million in punitive damages, Christiansen’s lawyers said. The jury found Nov. 24 that the Conserve device defective and that Wright failed to adequately warn patients about its risks. Read more


2. St. Jude Medical’s Proclaim Elite debuts in Europe

MassDevice.com news

St. Jude Medical said that it’s launching its Proclaim Elite spinal cord stimulation device in the European Union after winning CE Mark approval there, including an indication for conditional MR labeling for the Proclaim Elite for head and extremity scans.

The approval also covers St. Jude’s “burst stimulation” technology, which is designed to reduce the sensation of tingling along the spinal cord associated with tonic stimulation called paresthesia, according to the Little Canada, Minn.-based company. Read more


1. FDA deems Boston Scientific’s atherectomy component recall Class I

MassDevice.com news

The FDA slapped Class I status on Boston Scientific’s recall of nearly 1,000 components used with its Rotablator atherectomy device.

Boston Scientific warned doctors of the potential problem in October, after receiving 3 reports that the catheter’s guidewire fractured during procedures to remove plaque from the coronary arteries. In 1 case, the patient died 4 days after the wire fractured and the device’s rotating burr, moving at 195,000 to 200,000 rpm, pierced the artery wall, according to the FDA’s adverse events database. Read more

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Danaher lures ex-Medtronic legal eagle Ellis for GC spot | Personnel Moves

MassDevice.com Personnel MovesDanaher (NYSE:DHR) said it lured Brian Ellis from Medtronic (NYSE:MDT) to be its new general counsel, replacing Jonathan Graham, who jumpoed ship for Amgen (NSDQ:AMGN) last May.

Ellis was general counsel for Medtronic’s restorative therapies group, after stints as GC and chief compliance officer for monitoring solutions at GE Healthcare (NYSE:GE)

“Brian brings a wealth of experience leading and developing global legal teams and supporting business growth. I am confident that Brian’s background and experience position him to be a major contributor at Danaher,” president & CEO Thomas Joyce Jr. said in prepared remarks.

 Akers Biosciences’ new CEO is BD vet Gormally
Akers Biosciences said it tapped Becton Dickinson & Co. (NYSE:BDX) veteran John Gormally to be its new CEO.
Read more

 Uluru CEO Gray bows out
Uluru (OTC:ULUR) said president & CEO Kerry Gray resigned Nov. 20 and was replaced on an interim basis by board member Helmut Kerschbaumer.
Read more

 Alphatec loses int’l SVP Bullivant
Alphatec (NSDQ:ATEC) said senior vice president of international Mark Bullivant resigned Nov. 13, with his duties to be assumed by other executives at the company.
Read more

 Tandem Diabetes commercial chief Anacone steps down
Tandem Diabetes Care (NSDQ:TNDM) said its chief commercial officer, Robert Anacone, plans to retire effective Dec. 31.
Read more

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NinePoint Medical raises $30.7m for NvisionVLE imaging system

NinePoint MedicalNinePoint Medical reported a funding round worth $30.7 million as it seeks to expand the commercial footprint for its NvisionVLE imaging system.

The equity round, which began Nov. 12, involved 3 unnamed investors, according to a regulatory filing. Bedford, Mass.-based NinePoint hopes to raise a total of $40.7 million, according to the filing.

NinePoint’s NvisionLVE system is designed to provide high-resolution endoscopic images of organs and tissues. The system can provide cross-sectional, volumetric views of organs, including tissues below the surface, according to the company.

Last year NinePoint raised a $34 million Series B round, led by Corning Inc. (NYSE:GLW), along with founding investors Third Rock Ventures and Prospect Venture Partners.

Nearly a year ago, NinePoint tapped Chris von Jako, the former CEO of NeuroTherm, to be its new CEO. Von Jako declined to comment to MassDevice.com about the funding.

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Biolitec loses Supreme Court bid to overturn $75m contempt ruling

Angiodynamics BiolitecGerman medical laser maker Biolitec (ETR:BIB) today lost its bid to have the U.S. Supreme Court review an appeals court decision upholding a $75 million contempt penalty in its longtime legal dispute with  AngioDynamics (NSDQ:ANGO).

Judge Michael Ponsor of the U.S. District Court for Massachusetts slapped Biolitec with a $75 million contempt ruling last year, after finding that it deliberately effected a so-called “downstream merger” to move its incorporation to Austria to escape jurisdiction in U.S. courts. Ponsor’s harshly-worded ruling trebled the $23.2 million awarded to AngioDynamics by a New York court in 2012, adding $3.6 million in interest and another $1.9 million in legal costs, according to court documents.

Ponsor also issued an arrest warrant for ex-Biolitec CEO Wolfgang Neuberger and imposed an injunction on sales of some of Biolitec’s vascular offerings. Ponsor also levied a hefty fine schedule against Biolitec to compel it to undo the merger, beginning with $1 million in May 2013, escalating to $2 million the next month, $4 million in July 2013, $8 million in August and $8 million a month thereafter.

Biolitec appealed Ponsor’s rulings to the U.S. Court of Appeals for the 1st Circuit. In June the appeals court affirmed the lower court judge and scorched Biolitec in dismissing the appeals, but ruled against the indefinite escalation of the penalties, which reached $160 million. Ponsor reduced the penalties to $75 million on remand from the 1st Circuit, according to court documents.

In a certiorari petition filed July 1 with the Supreme Court, Biolitec argued that the 1st Circuit decision adds to the confusion on the difference between criminal and civil contempt. The high court today declined to grant the petition without comment. That means the 1st Circuit’s decision stands, putting Biolitec on the hook for the $75 million penalty tab.

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Supreme Court denies Covidien in $177m surgical shears spat with J&J’s Ethicon

Covidien, Ethicon Endo-SurgeryThe long-running patent infringement war between Medtronic’s (NYSE:MDTCovidien subsidiary and Johnson & Johnson‘s (NYSE:JNJ) Ethicon Endo-Surgery unit over surgical shears appears to be over, after the U.S. Supreme Court today declined to review the case.

Covidien in August asked the Supremes to hear its appeal of a December 2014 decision by the U.S. Court of Appeals for the Federal Circuit, which overturned a $177 million award to Covidien in the U.S. District Court for Connecticut. There, Judge Janet Bond Arterton had ruled that Ethicon Endo-Surgery infringed surgical shears patents held by Covidien’s corporate predecessors, Tyco Healthcare and U.S. Surgical Corp.

The Federal Circuit vacated the damages award, ruling that an Ethicon prototype anticipated the Covidien devices “because Ethicon conceived of the prototype before Tyco’s January 1997 conception date and diligently reduced it to practice without abandoning, suppressing, or concealing it thereafter,” Chief Judge Sharon Prost wrote for the 3-judge appeals panel. “The district court improperly held that the Ethicon prototype could not be considered prior art … and erred in finding that the curved blade claims and dual [cam] claims would not have been obvious.”

The high court’s decision, in which Justice Samuel Alito did not take part, means the Federal Circuit decision stands.

The companies agreed earlier this month to bury most of the hatchet, agreeing to drop the case with each side bearing its own legal costs, except for the then-pending Supreme Court bid.

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Report: IPOs headed for 6-year low

Initial public offering (IPO)The market for initial public offerings is headed for a 6-year low not seen since the economy imploded in 2009, according to a report from Renaissance Capital.

There have been 168 IPOs so far this year, raising $30 billion, which is the lowest mark since 2009, according to the report. There were 275 public flotations last year and 222 in 2013, Renaissance said. There were an average of 136 IPOs per year from 2010 to 2012, the company said.

The subdued market means that the usual post-Thanksgiving IPO flurry, as banks look to price before the window closes in mid-December, isn’t likely to happen this year.

“In healthy years, December can see as many as 15-20+ IPO launches, but for 2015 investors should expect a very quiet month,” the company said.

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Titan Medical inks instruments deal with Cadence Device

Titan MedicalTitan Medical (CVE:TMD) said today that it inked a deal with Cadence Device for instruments for its Sport robot-assisted surgery platform.

The deal calls for Cadence to develop, manufacture and manage the supply chain for the instruments, Toronto-based Titan said.

“We are very excited to partner with Cadence, a leading contract manufacturer in the medical field. Their proven level of expertise will be key for the development and manufacture of innovative multi-articulating instruments, which are important for Titan’s success as we move closer to the commercialization of the Sport surgical system,” Titan chairman & CEO John Hargrove said in prepared remarks.

“We are pleased to partner with Titan to help design and build the instrumentation for the Sport surgical system. We are very impressed with what Titan is preparing to bring to the market and look forward to playing a key role in the continued advancement of this novel robotic system,” added Cadence president & CEO Alan Connor.

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Diabetes: Medtronic launches ‘Pattern Snapshot’ for iPro2 CGM

Medtronic's Pattern Snapshot for iPro2Medtronic (NYSE:MDT) said today that it launched a new “Pattern Snapshot” report for its iPro2 professional continuous glucose monitor that’s designed to give healthcare providers a 1-page overview of a patient’s glucose data trends.

The Pattern Snapshot report, part of Fridley, Minn.-based Medtronic’s CareLink iPro diabetes management software, is designed to identify the top 3 patterns in a patient’s blood glucose levels that could indicate glucose control issues and causes. The iPro2 device is designed to record glucose levels 24 hours a day for 3 days, Medtronic said.

“We developed this rule-based, simplified report to enhance the use of professional CGM as part of the overall diabetes management regimen,” non-intensive diabetes therapies general manager Laura Stoltenberg said in prepared remarks. “HCPs will now have a simplified report that will allow for faster interpretation of the most important diabetes metrics, so they can quickly uncover their patient’s most important issues.”

“The retrospective CGM technology of Medtronic’s iPro2 professional CGM presents the patient and provider with accurate information that allows personalized treatment decisions. This comprehensive yet easy-to-interpret continuous glycemic data will arm the care team with valuable and previously difficult to obtain data,” added Dr. Todd Zeiger of Cincinnati’s UH Primary Care Institute.

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Jury hits Wright Medical with $11m verdict in Conserve hip implant bellwether

metal-on-metal hip implantsA federal jury in Georgia last week handed an $11 million loss to Wright Medical (NSDQ:WMGI) in the 1st bellwether trial in the multidistrict litigation filed over its Conserve metal-on-metal hip implant.

The Atlanta jury awarded plaintiff Robyn Christiansen $1 million in compensatory damages and another $10 million in punitive damages, Christiansen’s lawyers said. The jury found Nov. 24 that the Conserve device defective and that Wright failed to adequately warn patients about its risks.

The 2-week trial was the 1st of roughly 550 product liability lawsuits filed over the Conserve implant that have been consolidated before Judge William Duffey of the U.S. District Court for Northern Georgia. The jury deliberated for 3 days, according to the lawyers.

Christiansen, a former ski instructor from Utah, alleged in 2013 that her Conserve implant came loose and caused tissue damage.

“We’re very pleased with the verdict,” attorney Michael McGlamry told the Atlanta Journal-Constitution. “We’re also especially pleased for Ms. Christiansen. She saw this not just as her case, but the 1st of all of the rest of the cases.”

“We disagree with the verdict, are considering all of our post-trial options and expect that we will appeal the decision if it is permitted to stand,” Julie Tracy, Wright Medical’s chief communications officer, told the newspaper.

Material from Reuters was used in this report.

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Siemens Healthcare wins FDA nod for robotic X-ray scanner

SiemensSiemens Healthcare (NYSE:SI) said it won 510(k) clearance from the FDA for its Multitom Rax robotic advanced X-ray scanner, which is designed to function across multiple clinical areas.

Malvern, Pa.-based Siemens Healthcare said the Multitom Rax is designed to cover examinations ranging from emergency medicine and interventional to pain management and orthopedics, using 1 room and a single X-ray system. The system is the 1st to provide #d natural weight-bearing images, the company said.

“With the Multitom Rax, Siemens is proud to introduce the world’s first twin robotic X-ray system,” X-ray products vice president Martin Silverman said in prepared remarks. “This universal X-ray system delivers unprecedented versatility for health care facilities. Now, clinicians can perform a multitude of imaging exams in one room without moving the patient. With the Multitom Rax, we’re opening a new chapter in X-ray technology.”

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UPDATE: FDA deems Boston Scientific’s atherectomy component recall Class I

Boston ScientificThe FDA last week slapped Class I status on Boston Scientific‘s (NYSE:BSX) recall of nearly 1,000 components used with its Rotablator atherectomy device.

Boston Scientific warned doctors of the potential problem in October, after receiving 3 reports that the catheter’s guidewire fractured during procedures to remove plaque from the coronary arteries. In 1 case, the patient died 4 days after the wire fractured and the device’s rotating burr, moving at 195,000 to 200,000 rpm, pierced the artery wall, according to the FDA’s adverse events database.

The federal safety watchdog’s Class I recall status denotes the risk of serious injury or death.

In the Oct. 8 letter, Marlborough, Mass.-based Boston Scientific said it was recalling 955 of the RotaWire Elite and WireClip torquer components.

“During the limited market release, Boston Scientific has received 3 complaints for wire fracture. One fracture occurred during device prep, and the other 2 fractures occurred during the procedure resulting in burr migration into the pericardium. One of these involved placement of a covered stent to address vessel perforation. That patient subsequently expired. The other required surgery for removal of the fragment,” according to the letter.

The FDA, in labeling the recall as Class I, said the cause was a component change control; in June, Boston Scientific won approval from the federal safety watchdog to change its core wire vendor and rebrand the RotaWire as the RotaWire Elite.

According to an Oct. 1 report in the FDA’s Manufacturer & User Facility Device Experience database, the RotaWire Elite fractured during a Sept. 30 procedure to ablate plaque in a heavily calcified lesion in the ostial/proximal right coronary artery, perforating the vessel.

“The burr and part of the wire was removed; however, 20-30cm of the distal wire was left inside the patient. A non-[Boston Scientific] covered stent was deployed to seal the vessel perforation. Four days later, the patient died,” according to the MAUDE report.

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St. Jude Medical’s Proclaim Elite debuts in Europe

St. Jude Medical's Proclaim Elite spinal cord stimSt. Jude Medical (NYSE:STJ) said today that it’s launching its Proclaim Elite spinal cord stimulation device in the European Union after winning CE Mark approval there, including an indication for conditional MR labeling for the Proclaim Elite for head and extremity scans.

The approval also covers St. Jude’s “burst stimulation” technology, which is designed to reduce the sensation of tingling along the spinal cord associated with tonic stimulation called paresthesia, according to the Little Canada, Minn.-based company.

The Proclaim Elite device can also be fine-tuned via Bluetooth by doctors using Apple’s (NSDQ:AAPL)mobile devices, which can also be used as the patient’s controller, St. Jude said.

Earlier this month, St. Jude won FDA approval for the Proclaim Elite, claiming it as the sole U.S.-approved upgradable and recharge-free SCS system. The company is running an investigational device exemption trial in the U.S., using its Prodigy device. St. Jude said it expects to present results from the trial at the North American Neuromodulation Society’s annual meeting in Las Vegas next month.

“We developed the Proclaim Elite SCS system to create a more patient-centric spinal cord stimulation therapy option,” neuromodulation medical director Dr. Allen Burton said in prepared remarks. “With the launch of this device we are transforming the standard of care by packaging a series of important benefits into a single SCS device. The Proclaim Elite SCS system offers patients a combination of advanced pain therapy options and the convenience of a device that doesn’t require recharging, while removing barriers for future therapy and diagnostic options.”

“With the Proclaim system, we’re seeing a shift in the SCS treatment paradigm as we move to a device that’s capable of delivering effective therapy tailored to a patient’s pain condition but that requires no device recharging,” added Dr. Frank Huygen of Holland’s Erasmus MC Hospital. “By combining burst stimulation and upgradeability in a non-rechargeable device, this innovative technology ensures physicians are more empowered to deliver therapy that can appropriately address our patients pain while keeping them on the forefront of therapy advancements as they are approved and securing access to MRI head and extremity scans if needed.”

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Diagnosing pediatric vestibular issues with an iPhone in a bucket

vector-blog-nov-30-1x1Dizziness is fairly common in children, but it can be very hard to diagnose the cause. Any number of conditions can produce dizziness, and children are a special challenge since they often can’t describe what they’re feeling.

“One of the toughest things to figure out is, is it a problem with the vestibular system, or is it part of something else, a heart problem or an eye problem?” says Jacob Brodsky, MD, director of the Balance and Vestibular Program at Boston Children’s Hospital. “Then, the next challenging part is determining whether it is an inner ear problem or a central vestibular disorder — a problem with the brain.”

A definitive answer often requires a battery of tests that few providers outside Boston Children’s can perform in children, as they require sophisticated and expensive equipment. But with an ordinary bucket, an iPhone, an $18 app and some Velcro, Brodsky can quickly get a good indication of whether a child has a vestibular problem—and specifically an inner ear problem.

Vector-green logo

A poor man’s vestibular test

In the current state-of-the-art test, called the “subjective visual vertical,” or SVV, the patient is placed in a darkened room, shown a slightly off-kilter vertical line projected on a screen and asked to adjust the line with a remote until it appears precisely vertical.

“We can then measure how many degrees this differs from the true vertical,” explains Brodsky. This helps confirm that the dizziness is coming from a peripheral vestibular problem — vestibular loss in the inner ear rather than a brain problem.

An Australian clinician, Matthew Holmes, realized you could reproduce this test much more cheaply, with an iPhone app that displays the same vertical line.

Read the full post on VectorAn iPhone and a bucket help diagnose vestibular problems in dizzy children

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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dimecres, 25 de novembre del 2015

FDA warns cosmetic device maker over lack of approval, demands halt to sales

FDA, A-1 EngineeringThe FDA this week released a warning letter it sent to cosmetic device maker A-1 Engineering over a lack of FDA clearance to market its devices, requesting the company halt sales of the devices.

The federal watchdog also referenced a number of quality control issues with the company’s manufacturing facilities in Rancho Cucamonga, Calif.

A-1 Engineering makes the Neurotris SX-Series machines and Neurotris PICO Toner microcurrent facial and body sculpting systems, which the company claims are “a non-surgical approach to improve and return a youthful appearance,” according to its site.

The FDA said the company registered the devices originally as “electric therapeutic massagers,” which are exempt from the need for premarket approval, but the company has marketed them outside that indication.

“Generic devices of this type (electric therapeutic massagers) are intended for medical purposes, such as to relieve minor muscle aches and pains. However, your firm is marketing the devices for different intended uses, including, but not limited to, wrinkle reduction, facial lifting, neck tightening, increased ATP production, increased collagen and elastin, improved circulation, skin tightening, cellulite reduction, enhancement of biological processes, hydrolysis of triglycerides, improving sun damaged skin and skin pigmentation, iontophoresis, fat reduction, and muscle building and toning,” the FDA wrote in its warning letter.

The FDA quoted the company’s brochures, which advertise the devices as being able to far exceed the purpose they were registered under, referencing a grocery list of claims outside the devices original marketed indication.

The federal watchdog requested that A-1 “immediately cease activities that result in the misbranding or adulteration of the Neurotris SX-Series Machines and PICO Toner,” including halting all commercial distribution of the devices.

In addition, the FDA knocked the company on 7 different points from its inspection of A-1’s facilities.

Included in the list were: failure to maintain device master records; failure to maintain device history records; failure to establish procedures to ensure sold devices conform to requirements; failure to evaluate potential suppliers based on evaluations; failure to maintain complaint files; failure to establish cleaning and maintenance schedules and a failure to establish quality system procedures.

A-1 was asked to submit an application for premarket approval and the FDA requested the company respond within 15 days to the notification.

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MassDevice.com +3 | The top 3 medtech stories for November 25, 2015

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Say hello to MassDevice +3, a bite-sized view of the top three medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 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.

 

3. Study: Medical device industry pumps $2.6B into Memphis economy

MassDevice.com news

A study from the Greater Memphis Medical Device Council reports that the medical device industry has brought approximately 17,000 jobs and $2.6 billion.

The study, which was funded by a grant from the Memphis-Shelby County Economic Development Growth Engine, relied on data from 50 surveyed medical device companies as well as data from the U.S. Bureau of Economic Analysis. Read more


2. Dilon inks distro deal with GE Healthcare for breast imaging system

MassDevice.com news

Dilon Diagnostics said it signed a deal with GE Healthcare to distribute its GE Discovery NM750b molecular breast imaging system in select locations.

The businesses said the agreement is an “initial step” in an ongoing exploration of ways to provide better healthcare solutions for clinicians and patients. Read more


1. Dell gets into medical imaging, inks deal with Zebra

MassDevice.com news

Dell said it jumped into the medical imaging market with its Dell medical Review 24 Monitor and signed a multi-year agreement with Zebra Medical Vision to distribute its Clinical Research and Analytics platform.

Dell’s new medical monitor will debut at the Radiological Society of North America’s annual meeting. Read more

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Moximed wins CE Mark for Atlas ‘shock absorbing’ knee

MoximedMoximed said last week it won CE Mark approval in the European Union for its Atlas ‘shock absorber’ knee joint unloader for pre-arthroplasty patients.

The Atlas system is an implantable joint unloader placed subcutaneously along the knee joint to absorb excess joint load rather than transfer it to healthy areas of the joint, the Hayward, Calif.-based company said.

Treatment with the system is reversible, Moximed said, leaving patients with future treatment options if their osteoarthritis becomes too severe.

“We are proud to have implanted the first CE Marked Atlas Systems worldwide. The Atlas System provides the same amount of joint unloading as the previous generation device, but it now offers a smaller device footprint and a surgical technique customized to the patient’s own anatomy. We anticipate the Atlas System will be used for a significant portion of our knee practice,” Dr. Claudio Zorz of Verona, Italy’s Ospedale Sacro Cuore Don Calabria said in prepared remarks.

The device was approved at least partially based on a 40-patient prospective, multi-center clinical study, in which study investigators reported “consistently rapid recovery and return to daily activities” after the therapy, the company said.

“We are pleased with the early clinical results and surgeon interest in the Atlas System. Building on our seven years of clinical experience with joint unloading, we are confident that the Atlas System will make a positive impact for osteoarthritis patients worldwide. We believe the Atlas System provides a significant segment of osteoarthritis sufferers the joint preserving option that will allow them to live the highly active lives that they expect and deserve,” Moximed CEO Kevin Sidow said in a press release.

In May, Moximed pulled in a $33 million Series B round for its KineSpring knee implant, which is designed to reduce the load on the joint while sparing its anatomy.

The Hayward, Calif.-based company said new backer Vertex Venture Holdings joined prior investors New Enterprise Assoc., Gilde Healthcare Partners, Morgenthaler Ventures and GBS Venture Partners in the round.

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Fujifilm submits 2nd PMA module for tomosynthesis breast imager

Fujifilm Medical SystemsFujifilm Holdings (TSE:4901) said yesterday it filed a 2nd pre market approval module for a digital breast tomosynthesis upgrade for its Aspire Cristalle mammography system.

The company expects to submit the remaining modules for the DBT upgrade, known as Amulet Innovality outside of the U.S., within the coming year.

“Digital breast tomosynthesis technology is making a positive difference for women and clinicians around the world. This recent submission is a significant step toward launching our innovative solution here in the U.S. We’re proud to announce this latest move forward in our goal to support better breast cancer detection and diagnosis with DBT technology that delivers high quality images at a low dose,” digital x-ray and women’s health director of marketing and product development Rob Fabrizio said in a press release.

The company’s system features hexagonal close pattern detector pixel design, intended to improve image quality, Fujifilm said.

The device is also designed to be more comfortable for mammography patients, requiring lower doses for imaging and integrating soft edges and 4-way pivoting to contour to to different body shapes.

The digital breast tomosynthesis system has been available since 2013 in Europe, Asia and Latin America, Fujifilm said.

Fujifilm submitted the 1st module in July.

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Report: Ransomware on the horizon for medical devices

Cybersecurity in medical devices

Life-saving medical devices could be held hostage by ‘ransomware’ as early as next year, according to a report from Forrester Research, Inc.

Ransomware is effectively digital extortion – malicious programs that control user devices and files until the user ponies up, usually in the digital currency Bitcoin.

This year has seen significant growth in ransomware cases, and the malicious programs are expected to expand into other fields as more and more devices pick up connectivity to enable an ‘Internet of Things.’

“Ransomware grew rapidly in 2015 thanks to the popularity of ransomware families like CTB-Locker, Teslacrypt, and CryptoWall. Motivated by the rise of virtual currencies and the number of victims who have demonstrated a willingness to pay to regain access to their data, cybercriminals are embracing cyber extortion,” Forrester Research, Inc wrote in its report.

Unlike ransomware cases involving files and devices held hostage, holding medical devices, such as connected pacemakers or drug infusion pumps, could create a much more serious issue with a risk of serious injury or death.

“Thats a bold specific prediction. I hope it doesn’t happen as they say it will, because that would shatter our confidence in these life-saving devices,” grassroots cybersecurity and public safety group I Am The Cavalry founder Joshua Corman told Vice’s Motherboard in an interview.

“People who say ‘oh but no one would ever do that’ fail to understand that on the internet, every sociopath is your next door neighbor,” Corman told Motherboard. “Assuming that no one would do this is naive, and assuming that organizations are capable of stopping it is unmerited trust.”

An increase in connected devices, data-driven patient analytics a move to electronic health records is making medical devices, and electronic health records themselves, more attractive targets for such activity.

Stolen health credentials can sell for $10 each, roughly 10 to 20 times what stolen credit card numbers go for, but that’s not much compared to the value of a full EHR on the black market.

Full electronic health records are the Cadillac of stolen data, fetching upwards of $300 for a complete file, according to the Infosec Institute. That’s more than any other piece of data from any other industry, making it a highly valuable target.

The FDA has been vigilant on warning the medical device industry about issues associated with hacked device and hospital cybersecurity issues. In August, the federal watchdog warned about a flaw in Hospira‘s (NYSE:HSP) Symbiq drug infusion pump that hackers could exploit to take over the device.

The Agency said the Symbiq pump can potentially be accessed remotely through a hospital’s network, potentially opening the door to unauthorized changes to the dosage delivered by the pump, according to the federal safety watchdog. The flaw was confirmed by Hospira and an independent researcher. Although no adverse events or unauthorized access in a healthcare setting have been reported, according to the FDA and Hospira, the agency encouraged hospitals and facilities to disconnect all Symbiq devices from their networks. Hospira began phasing Symbiq out in May after the FDA warned on cybersecurity vulnerability issues with its remotely-programmed LifeCare PCA3 and PCA5 devices.

Malicious hackers have already used unprotected medical devices to break into hospital IT systems in at least 3 instances discovered by a cybersecurity firm in July, as medical data becomes a holy grail for organized crime “medjacks.”

In October 2014, the FDA issued pre-market submission guidance advising companies to pay closer attention to cybersecurity issues during the development and design phases of their products. Areas of concern included malware, password protection, the timely issuance of software patches and updates, and potential security flaws in off-the-shelf software. The Agency also asked companies to submit cybersecurity risk assessment for their products as part of their premarket application process. Companies should also detail how they plan to provide validated software updates during the lifecycle of the product.

The industry has been gallant in responding to the threat. Last month at a seminar held by the Mass. Medical Device Industry Council (MassMEDIC), medical device executives, regulators and security experts discussed which systems and devices were most vulnerable to malicious hacking and what could be done to stop it.

MassMEDIC President Thomas Sommer said his group decided to hold the seminar in response to reports that hacking is on the rise, particularly the theft of patient data.

“It’s something that small and mid-sized companies are now focusing on. The larger companies have had robust plans in place for some time,” Sommer told MassDevice.com. “The medical device industry is now joining other tech-based industries in developing security plans for their devices.”

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Xenios wins CE Mark for I-Cor cardiac assist device

Xenios AGXenios said yesterday that it won CE Mark approval in the European Union for its I-Cor synchronized cardiac assist device, touting it as the world’s 1st “heartbeat-synchronized” cardiac assist for cardiogenic shock and high-risk interventions.

Heilbronn, Germany-based Xenios, which claimed in September to have drummed up an 8-figure funding round, said the I-Cor system is designed to provide “beat-to-beat” cardiac assistance using a miniature pump “with synchronized pulses that are superimposed over the patient’s weakened heartbeats.”

“European regulatory approval of the I-Cor synchronized cardiac assist system now makes possible a whole new era for percutaneous cardiac assist,” managing director Dr. Georg Matheis said in prepared remarks. “We are able to superimpose or overlay an artificial heartbeat over each weakened heartbeat. Previously, there has been no such direct cardiac-assist modality. … This advance not only makes possible new therapy options for patients who are suffering from cardiogenic shock, but also is designed to bridge patients across high-risk interventions in the cardiac cath lab.”

“Patients with cardiogenic shock have a very high mortality rate,” added managing director Dr. Juergen Boehm. “In fact, cardiogenic shock as the result of a heart attack is a medical emergency, resulting from an inadequate circulation of blood due to primary failure of the heart ventricles to function effectively. As this is a type of circulatory shock, there is insufficient perfusion of tissue to meet the demands for oxygen. The condition involves increasingly more pervasive cell death from oxygen starvation (hypoxia). We are pleased that interventionists will now have a powerful new treatment with which to reduce morbidity and mortality from cardiogenic shock or high-risk interventions.”

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