Avinger touts 2-year Pantheris study data

Avinger today released data from the pivotal vision study of its Pantheris system, touting high survivability and freedom from target lesion revascularization in patients treated with the system.

The 89-patient Vision study aimed to evaluate the safety and effectiveness of its Pantheris directional atherectomy system which uses real-time intravascular imaging to remove plaque from diseased lower extremity arteries.

The Redwood City, Calif.-based company said that all primary and secondary endpoints of the trial were achieved.

Results from the trial were presented at the New Cardiovascular Horizons meeting in New Orleans by Dr. Patrick Muck of Cincinnati’s Good Samaritan Hospital.

“The complete Vision 24-month data demonstrates positive longer-term sustained results for patients treated with Pantheris, and importantly, these patients have largely avoided the need for a repeat procedure in a two-year timeframe. Considering that the outcomes were generated at the hands of brand new users with a first-generation clinical trial device, such positive results represent an important step forward for Pantheris in the clinical setting,” Dr. Muck said in a prepared statement.

Data indicated an 82% freedom from TLR at 12 months and 74% freedom from TLR at 24 months, with Kaplan Meier freedom from TLR at 24 months remaining stable between 18 and 24 months, the company said. Results also indicated statistically significant improvements in ankle brachial index and Rutherford classification at 30 days, which were maintained through 2 years.

Avinger said that a majority of lesions treated in the study were treated using standalone optical coherence tomography guided atherectomy with the Pantheris catheter. Only 9.6% of patients received adjunctive drug coated balloon therapy, and only 5% received adjunctive stent therapy.

“These excellent results continue to reinforce our enthusiasm for the Pantheris System. We are gratified that Lumivascular technology is improving the lives of patients with PAD, including many facing amputation. In the meantime we continue to refine the system, with Pantheris 3.0, our next-generation atherectomy catheter, and a lower-profile Pantheris device currently in development,” founder & exec chair Dr. John Simpson said in a press release.

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Aurora Spine shops licensing deal for polyaxial implant system

Aurora Spine (TSX:ASG.V) said today it will look for licensers for its proprietary polyaxial interspinous fusion implant locking system.

The Carlsbad, Calif.-based company said that it will be looking for both industrial and medical applications for the patented tech, entitled polyaxial interspinous fusion implant and bone growth stimulation system.

“Aurora Spine is now offering its new Polyaxial ZIP Interspinous device patent for out-licensing or private label opportunities. The combination of the proven One-Step locking mechanism, with no setscrew, and the polyaxial feature could be a unique opportunity in new product development for orthopedic and other medical and industrial manufacturers,” prez & CEO Trent Northcutt said in a prepared statement.

“Aurora’s patented features offer new design directions for hardware connections that do not rely on conventional threads and screws thus preventing hardware loosening related problems,” CTO Laszlo Garamszegi said in a press release.

In January, Aurora Spine said it named Sarina Mason as its chief financial officer, effective Feb. 6., to replace Eric Fronk, who resigned from the company to pursue other opportunities.

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Saphena Medical raises $3m

Saphena Medical said raised $2.7 million in a new round of equity financing, according to an SEC filing posted today.

The company offered Series C preferred stock during the round, according to the SEC filing, with the 1st sale recorded on May 17.

A total of 38 unnamed investors have joined the round, with Saphena looking to raise an additional $800,376 before closing it, according to the SEC filing.

In February, Saphena and Dr. Albert Chin filed counterclaims against Getinge‘s (PINK:GETI B) medical subsidiary Maquet Cardiovascular in response to a suit alleging patent infringement and breaches of contract.

The counterclaim, filed on Feb. 22, is in response to an ongoing spat between the companies related to patents and intellectual property pertaining to endoscopic vessel harvesting devices, specifically Saphena’s Venapax system.

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Japan clears Augmenix’s SpaceOAR

Augmenix said yesterday it won Shonin approval from the Japanese Ministry of Health, Labor and Welfare for its SpaceOAR system.

The SpaceOar is designed to separate the prostate from the rectal wall during radiation treatment for prostate cancer, the Belford, Mass.-based company said.

The device is delivered through a small needle as a liquid, which then solidifies into a soft gel that expands the space between the prostate and rectum during radiotherapy. The substance then liquefies and is absorbed and cleared from the body in the patient’s urine, Augmenix said.

“SpaceOAR hydrogel is a major advance to significantly reduce risks of prostate cancer radiation therapy and positively impact patients’ quality of life. We are very excited to have this technology available in Japan and look forward to its use in treating our prostate cancer patients,” Dr. Keiichi Nakagawa of the University of Tokyo Hospital said in a prepared statement.

“We now have extensive clinical data showing that SpaceOAR hydrogel helps to significantly reduce the risk of rectal and urinary toxicities and loss of sexual function associated with radiation therapy for men with prostate cancer. We are very pleased that the Shonin approval will enable physicians in Japan to offer SpaceOAR hydrogel as an option for men with prostate cancer who want to reduce their risk of radiotherapy side effects including rectal toxicity, incontinence and loss of sexual function,” Augmentix CEO John Pedersen said in a press release.

With the approval, the company’s SpaceOAR has CE Mark approval in the European Union, FDA clearance and approval in Australia and is licensed in Canada, the company said.

In February, Augmenix released data from a Phase III trial evaluating its SpaceOar hydrogel in men undergoing prostate radiotherapy. The study showed that the company’s device, placed between the prostate and rectum, helps men maintain sexual function and potency following radiation therapy.

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Report: Mylan may have overcharged US by $1.3B for EpiPen

Mylan (NSDQ:MYL) shares dipped slightly in mid-afternoon trading today after Sen. Chuck Grassley’s (R-Iowa) office released a Health and Human Services estimate claiming that taxpayers overpaid by as much as $1.27 billion for Mylan’s EpiPen device from 2006 to 2016.

The charges stem from Mylan’s decision to classify the emergency allergy auto-injector as a generic, instead of a branded product under the Medicaid Drug Rebate Program. Misclassifying the device allowed the company to pay the government a 13% rebate instead of a 23% rebate. The Centers for Medicare and Medicaid Services repeatedly warned Mylan that the device was wrongly classified, but the company didn’t take action.

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

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Powered clothing dev Superflex raises $10.2m

Robotics focused developer Superflex has raised $10.2 million in a new round of equity financing, according to an SEC filing posted this week.

Superflex is a spin-off of research group SRI International which is focused on developing wearable robotics designed to enhance the human musculoskeletal system.

The company’s technology is based on the DARPA-funded “Warrior Web” program which looked to improve soldier performance while reducing injury risk and increasing carrying capacity of soldiers, the Menlo Park, Calif.-based company said.

Money in the round came from 10 unnamed investors, with the 1st sale recorded as taking place on Nov. 14, 2016. The company is looking to bring in $1 million more during the round, according to an SEC filing.

The company has not yet stated how it intends to use funds raised in the round.

Superflex’s initial development will be Powered Clothing, designed to be worn under outfits with integrated electric “muscles” that add intelligent, wearable strength for individuals including those with a wide range of physical disabilities.

The company will focus on the aging market initially, though said that the same technology could hold potential applications in sports and recreational markets.

Superflex said its initial project will be a powered suit designed for individuals experiencing mobility difficulties and working in challenging environments to support the wearer’s torso, hips and legs. The suit will be designed to react to the body’s natural movements to provide powered lift in complement of an individual’s own strength, according to a press release.

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

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. J&J’s DePuy Synthes touts 4-year Attune knee revision data

Johnson & Johnson subsidiary DePuy Synthes today touted 4-year data from a large registry study showing that its Attune knee implant had a lower revision rate than the overall rate for total knee replacement.

The study examined data from 10,605 Attune implantations in Britain’s National Joint Registry for England, Wales, Northern Ireland & the Isle of Man, finding that the revision rate for Attune was 1.3% at 4 years, compared with the registry’s 1.9% average. Just 46 of the Attune knee procedures required revision, DePuy Synthes said. Read more

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4. Medtronic launches opioid-induced respiratory depression study

Medtronic said today that it’s starting a large study on the effect of pulse oximetry and capnography in opioid-induced respiratory depression, using its Capnostream device.

The 1,650-patient Prodigy study aims to create a tool to score the risk of OIRD in patients being treated with opioids for pain, using Capnostream’s continuous pulse oximetry and capnography monitoring over 48 hours. The study is slated for a final data collection for the primary outcome in February 2018 and an estimated completion date a month later, according to ClinicalTrials.gov. Read more

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3. Researchers find 8k cyber vulnerabilities in pacemakers

Researchers from the security research firm WhiteScope identified cyber vulnerabilities in file system encryption and in the storage of unencrypted patient data across major vendors of implantable cardiac devices, according to the team’s report.

“The findings reveal consistency across all vendors, highlighting the inherent weaknesses in the ecosystem architecture,” the firm wrote. Read more

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2. AngioDynamics levels anti-trust suit against Bard over catheter tip locators

AngioDynamics said it leveled an anti-trust lawsuit against C.R. Bard, alleging that the larger company illegally ties the sales of its peripherally inserted central catheters to its tip location devices.

The lawsuit, filed today in the U.S. District Court for Northern New York, accuses Bard of maintaining its dominant position in the tip location market by only selling its proprietary offering with its own catheters. Read more

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1. Intuitive Surgical wins FDA nod for daVinci X platform

Intuitive Surgical said today it won FDA 510(k) clearance for its new da Vinci X robotic surgical system, with a planned release of the platform later this year.

The newly cleared da Vinci X system offers access to multiple robotic-assisted surgical technologies at a lower price than previous models, the Sunnyvale, Calif.-based company said. The system operates on the same vision cart and surgeon consoles used by the company’s flagship da Vinci Xi system. Read more

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Mylan board faces pressure from pension funds

Investors, including the New York City and State pension funds and the California State Teacher’s Retirement System, are urging shareholders to vote against Mylan (NSDQ:MYL) chairman Robert Coury and 5 other board members at the company’s upcoming annual meeting.

Coury was compensated with more than $97 million last year and some investors aren’t happy about it. The pensions funds are major institutional shareholders – together, they control 4.3 million shares of the EpiPen-maker.

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

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DoubleBlack Imaging buys Richardson Healthcare’s PACS imaging display biz

Richardson Electronics said last week it is selling its picture archiving and communications systems display business, including its Image Systems brand, to Double Black Imaging for an undisclosed amount.

The Image Systems portfolio includes 2MP through 6MP color and grayscale displays as well as proprietary CFS calibration software designed to simplify conformance and calibration of its displays.

Read the whole story on our sister site, Medical Design & Outsourcing

 

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Mallinckrodt mulls sale of generics biz

Mallinckrodt Pharmaceuticals (NYSE:MNK) is reportedly considering a sale of its generic drug unit in an effort to focus its portfolio on high-margin branded drugs, according to a report from Reuters.

The divestment comes only months after the company sold its nuclear imaging business to IBA Molecular for $690 million. The sale of its generics business could bring in as much as $2 billion to the pharmaceutical company.

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

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Baxter inks R&D deal with Mayo Clinic, initial focus on kidney disease

Baxter (NYSE:BAX) said today that it inked a research & development collaborative deal with the Mayo Clinic to develop new technologies and therapies designed to improve patient therapeutic care.

The pair will initially focus on kidney disease, with additional projects planned in other areas where breakthrough treatment options can be introduced and innovation can improve access to high-quality care.

“We are excited about combining Mayo’s clinical and research expertise with Baxter’s ability to apply and scale innovation. We are confident that this collaboration will help accelerate discoveries, development and application of life-changing therapies for patients,” Florida Mayo Clinic CEO Dr. Gianrico Farrugia said in a prepared statement.

The initial agreement will span 5-years, with a 5-year renewal option. Additional details of the deal were not disclosed.

“Baxter is pleased to work with Mayo Clinic, a world-renowned healthcare organization that shares Baxter’s passion for advancing patient-focused innovation. The combined power of our two organizations will help us advance new solutions to the most pressing healthcare challenges, further delivering on Baxter’s mission to save and sustain lives,” Baxter CEO & chair José Almeida said in a press release.

Earlier this month, Baxter said that after communicating with the FDA, it will pursue a regulatory pathway as a combination product for its new home peritoneal dialysis solution system.

The system is designed to produce sterile PD solutions using a small water filtration device designed to be placed in a patient’s home and integrated into its AMIA automated peritoneal dialysis system, the Deerfield, Ill.-based company said.

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Abbott’s MitraClip can be implanted through the jugular vein, too

[Image from St. Michael’s Hospital]

A Canadian cardiologist has successfully inserted Abbott Labs’s MitraClip through the jugular vein instead of the femoral vein, according to a recent report.

Dr. Neil Fam inserted the Abbott Laboratories device into an 86-year old patient with severe mitral regurgitation. Because of the patient’s age, traditional surgery to repair her mitral valve was not an option.

Mitral valve regurgitation occurs when blood leaks backward through the mitral valve when the left ventricle contracts, according to the American Heart Association. If gone untreated, leaves can cause increased blood pressure in the left atrium and can increase pressure in pulmonary veins. If severe, the pressure can result in fluid build-up in the lungs.

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

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These sensors can detect diseases using your breath

The researchers made sensors from porous thin films of organic conductive plastics with the goal of portable, disposable devices for medical and environmental monitoring. [Image from L. Brian Stauffer/University of Illinois]

Disease markers and toxins in a building’s air could soon be detected on portable and disposable sensor devices being created by University of Illinois researchers.

The device is made from small, thin, organic plastic that is in the shape of a square. The researchers have so far been able to monitor ammonia in patients’ breath, which can be an indicator of kidney failure.

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

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Chiltern acquires Integrated Development Associates

Contract research organization Chiltern announced today that it is expanding its Japanese and Asian presence through its purchase of Integrated Development Associates.

Financial terms of the deal were not disclosed.

IDA has staff in Japan, Korea and Southeast Asia – and offers opportunities to integrate the region into global drug development, according to Chiltern. IDA’s expertise includes establishing regulatory and development pathways in Japan, and implementing clinical trials across Asia.

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

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Orthopedic synthetic polymer dev Hyalex Ortho raises $16m in Series A

Orthopedic synthetic polymer developer Hyalex Orthopaedics said today it raised $16 million in a Series A round of financing, with funds slated to support its Hyalex technology platform.

The financing round was led by Canaan Partners and joined by Osage University Partners and Johnson & Johnson‘s (NYSE:JNJ) Innovation, JJDC Inc.

Boston-based Hyalex is developing a synthetic biomaterial based on technology licensed from Stanford University intended to mimic the structure and function of hyaline cartilage, which lines articulating joints at the hip, knee, shoulder and ankle.

“The technology offers the ability to maintain an extremely low wear profile even at high loads. Our vision is to leverage Hyalex’s unique mechanical, friction, and wear properties to replace arthritic cartilage while sparing healthy bone,” Hyalex co-founder & CTO Lampros Kourtis said in a prepared statement.

As part of the funding round, Mira Sahney was appointed CEO & prez of Hyalex, with Osage University Partners managing partner Bill Harrington, JJDC venture investments VP Renee Ryan and Canaan Partners GP Wende Hutton joining the board of directors.

“Backed by a body of scientific research and a leadership team with over 10 years of experience in orthopedics, Hyalex is poised to develop an innovative approach to treat osteoarthritis by replacing cartilage in joint surgery. While joint replacement surgery is a viable option for many patients experiencing joint degeneration, younger patients may encounter some limitations in mobility and face future joint revisions. A less invasive approach to treat osteoarthritis has significant potential and is needed to help these patients live full, active lives,” Canaan Partners GP and Hyalex board member Hutton said in a prepared statement.

Prior to joining Hyalex, Sahney served as senior VP and GM at Smith & Nephew (NYSE:SNN).

“The Hyalex polymer has the potential to replace damaged cartilage in joints, creating the opportunity for a less invasive, more anatomic solution in disease states such as osteoarthritis or cartilage injuries. We are seeking to use this technology to improve standard of care for the approximate three million joint replacement procedures annually worldwide, particularly for younger patients who seek long active lives following their surgeries,” CEO Mira Sahney said in a press release.

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Fitness trackers versus medical devices: What’s the difference?

[Image from Unsplash]

Recent research studies have been calling into question the accuracy of fitness trackers. So when would FDA step in and regulate them as medical devices?

It all comes down to the difference between low-risk general wellness devices and medical devices – a distinction covered in an FDA guidance document last year, said Michael Drues, a Boston-based regulatory consultant who has worked for both device companies and FDA.

“The technology of the device really matters very little. What is much more important is the labeling. … It is all about what we say about our device, not necessarily what it does or how it works,” said Drues, who is president of Vascular Sciences.

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

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Bayer wins FDA nod for connected MS auto-injector

Bayer (ETR:BAYN) said yesterday that the FDA approved a supplemental biologics license application for the BetaConnect Navigator and myBetaApp – software for its electronic BetaConnect auto-injector.

The company’s BetaConnect auto-injector administers Betaseron for patients with relapsing-remitting multiple sclerosis. The newly-approved software allows patients to connect their device with the myBetaApp on their mobile device or computer and share data with their healthcare team.

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

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Nanoparticles: An industry buzzword meets reality

Young startups backed by nanoparticle tech face a world hurdles before reaching the clinic. It’s been decades since the first innovations with nanotechnology – and experts are asking, “Where are all the drugs?”

It’s been more than 20 years since the FDA approved the first nanoparticle drug, Doxil. At the time, nanoparticles were heralded as a way to more efficiently deliver drugs that traditionally come with burdensome side effects, such as chemotherapy.

Since then, scientists have published an array of preclinical studies and academic papers evaluating various types of nanoparticles, including liposomes, antibodies and more. But some experts point out that in many instances, nanoparticle technology stalls before it can even get to the clinic.“Well, they haven’t really lived up to their promise,” said Keith Horspool, VP of pharmaceutics at Boehringer Ingelheim.

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

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J&J’s DePuy Synthes touts 4-year Attune knee revision data

Johnson & Johnson (NYSE:JNJ) subsidiary DePuy Synthes today touted 4-year data from a large registry study showing that its Attune knee implant had a lower revision rate than the overall rate for total knee replacement.

The study examined data from 10,605 Attune implantations in Britain’s National Joint Registry for England, Wales, Northern Ireland & the Isle of Man, finding that the revision rate for Attune was 1.3% at 4 years, compared with the registry’s 1.9% average. Just 46 of the Attune knee procedures required revision, DePuy Synthes said.

“This most recent analysis adds to the body of evidence on the positive performance of the Attune knee,” franchise medical director Joshua Bridgens said in prepared remarks. “The information and data in this analysis, such as reasons for revision and preliminary findings on patient-reported outcomes, continue to validate the design principles and our expectations for the clinical performance of the Attune knee.”

The results were presented at the annual meeting of the European Federation of the National Assocs. of Orthopaedics & Traumatology Congress in Vienna, DePuy Synthes said.

In March, the Warsaw, Ind.-based company touted the economic benefits of the Attune device, based on data from a variety of sources including the U.K.’s NJR.

Last month, DePuy Synthes said it acquired 3D printing technology assets from Tissue Regeneration Systems for an undisclosed amount, saying it plans to use the technology to create patient-specific, bioresorbable implants for correcting orthopedic and craniomaxillofacial deformities and injuries.

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Stago closes HemoSonics buy

Stago Group said today that it completed its acquisition of point-of-care blood diagnostics platform developer HemoSonics.

Charlottesville, Va.-based HemoSonics developed the Quanta Hemostasis Analyzer, which is designed to measure treatable aspects of hemostasis in approximately 15 minutes using its sonic estimation of elasticity via resonance (SEER) technology.

Financial details of the acquisition were not disclosed. The transaction is part of Stago’s efforts to diversity its portfolio of medical devices, according to the company.

“This significant step makes us very proud to contribute to the management of healthcare costs and to the improvement of patients outcomes worldwide,” chairman of the board, Lionel Viret, said in prepared remarks.

“Stago brings exceptional expertise in the field of thrombosis and hemostasis that will greatly advance our efforts to rapidly and effectively deliver a new standard of care for the management of bleeding in the critical care setting” HemoSonics president & CEO Timothy Fischer added.

Ferghana Partners was HemoSonics’ exclusive financial advisor for the transaction.

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Lamellar Biomedical launches dry-eye trial

Lamellar Biomedical said today that the 1st patients were enrolled in its trial evaluating Lamelleye for the treatment of moderate to severe dry-eye disease.

Lamelleye uses the Scotland-based company’s Lamellasome technology to mimic the actions of serous lamellar bodies and regulate interfaces between tissues and external environments.

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

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Researchers find 8k cyber vulnerabilities in pacemakers

Researchers from the security research firm WhiteScope identified cyber vulnerabilities in file system encryption and in the storage of unencrypted patient data across major vendors of implantable cardiac devices, according to the team’s report.

“The findings reveal consistency across all vendors, highlighting the inherent weaknesses in the ecosystem architecture,” the firm wrote.

Previous research has revealed security flaws in cardiac devices, including pacemakers. The WhiteScope researchers bought and evaluated parts of implantable cardioverter defibrillators and pacemakers from 4 major vendors.

Software sold by a company other than the cardiac device vendor is of particular concern. The 3rd party components can have vulnerabilities that go unnoticed or unpatched by the vendor.

The WhiteScope team identified a total of more than 8,000 vulnerabilities in 3rd party components across 4 manufacturers.

“Given the commonality of the findings across different vendors, identification of implementation vulnerabilities as to any one vendor may expose those same vulnerabilities in other vendors and should be considered carefully before public disclosure,” the report said.

The team noted that home monitoring devices, which receive updates using a patient support network, are at risk of receiving counterfeit firmware. Also vulnerable to hackers are hard drives used to program cardiac implants.

According to the study, vendors should assess their systems and use methods such as firmware packing and encryption to make it difficult for hackers to devise counterfeit firmware.

The report comes just weeks after a massive, international ransomware attack reportedly impacted certain medical devices within the U.S. healthcare system.

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Medtronic launches opioid-induced respiratory depression study

Medtronic (NYSE:MDT) said today that it’s starting a large study on the effect of pulse oximetry and capnography in opioid-induced respiratory depression, using its Capnostream device.

The 1,650-patient Prodigy study aims to create a tool to score the risk of OIRD in patients being treated with opioids for pain, using Capnostream’s continuous pulse oximetry and capnography monitoring over 48 hours. The study is slated for a final data collection for the primary outcome in February 2018 and an estimated completion date a month later, according to ClinicalTrials.gov.

“The Prodigy study allows us to deepen our understanding of the development of respiratory compromise, including OIRD, and determine strategies for earlier detection and prevention,” co-lead investigator Dr. Frank Overdyk, of the Roper St. Francis Health System in Charleston, S.C., said in prepared remarks.

The other lead investigators are Dr. Wolfgang Buhre of Holland’s Maastricht University Medical Centre and Dr. Ashish Khanna of Cleveland Clinic’s Lerner College of Medicine of the Case Western Reserve University, Medtronic said.

“The Prodigy study is indicative of our commitment to bring attention to respiratory compromise – an under-recognized, serious health condition that’s preventable,” added SVP Vafa Jamali. “Information is powerful and the ability to identify patients at risk for respiratory compromise who could benefit from continuous capnography and oximetry monitoring may improve patient safety throughout the hospital.”

Medtronic acquired Capnostream in the $50 billion buyout of Covidien, which itself acquired the technology with its $300 million acquisition of Israel’s Oridion in June 2012.

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AngioDynamics levels anti-trust suit against Bard over PICC tip locators

AngioDynamics (NSDQ:ANGO) said it leveled an anti-trust lawsuit against C.R. Bard (NYSE:BCR), alleging that the larger company illegally ties the sales of its peripherally inserted central catheters to its tip location devices.

The lawsuit, filed today in the U.S. District Court for Northern New York, accuses Bard of maintaining its dominant position in the tip location market by only selling its proprietary offering with its own catheters.

“By doing so, customers who want to buy Bard’s tip location systems must also buy Bard’s line of PICCs, preventing hospitals and other medical providers from purchasing AngioDynamics’ superior BioFlo PICCs,” AngioDynamics said in a press release.

The suit seeks an end to the alleged anti-trust violations, triple damages and legal costs, AngioDynamics said.

“We are committed to fighting Bard’s illegal scheme that has been detrimental to patients, reduced competition and led to increased cost in the marketplace; and violated the federal antitrust laws,” president & CEO Jim Clemmer said in prepared remarks.

“This case involves a classic violation of the antitrust laws. Bard has no justification for preventing purchasers from choosing to use its market-leading tip location systems with AngioDynamics’ innovative BioFlo PICCs,” added AngioDynamics anti-trust lawyer Philip Iovieno of Boies Schiller Flexner.

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Check-Cap raises $3m to support C-Scan device

Check-Cap (NSDQ:CHEK) said today it inked a definitive agreement with an institutional investor for approximately $2.7 million in gross proceeds, with the possibility of up to $5.6 million upon the exercise of warrants purchased in the offering.

The Israel-based company said it floated approximately 1.4 million ordinary shares at $2 per share, as well as 1-year warrants to purchase an additional 1.4 million shares at an exercise price of $2.13 per share. The warrants are immediately exercisable, the company said.

The private offering is expected to close before June 2, Check-Cap said, with funds slated to support the ongoing development of its C-Scan device, according to a press release.

Earlier this month, CheckCap said that it and its collaborative partner GE Healthcare (NYSE:GE) reached an initial milestone in their X-ray capsule manufacturing capabilities, while Check-Cap also saw shares rise after it released 1st quarter earnings that topped the Street.

Check-Cap said that X-ray sources produced at GE using custom manufacturing methods passed all tests required for compliance with C-Scan system specifications.

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Vascular graft dev Somahlution launches EU registry trial of DuraGraft

Vascular graft developer Somahlution said today it launched the DuraGraft European Registry clinical trial of its DuraGraft device, enrolling the 1st patient in the study.

In the registry study, investigators will evaluate the Jupiter, Fla.-based company’s DuraGraft, a vascular graft treatment designed to reduce the burden of ischemia reperfusion injuries, during use in coronary artery bypass grafting procedures.

The 1st patient was enrolled at Germany’s Helios Hospital Wuppertal, with enrollment also beginning at the Helios Heart Center Leipzig. The 1st patient was treated by Dr. Herbert Vetter, Somahlution said.

“Initiation of the DuraGraft Registry marks an important milestone in the future of CABG surgery. Vein grafts have remained a concern, however we are now hopeful that DuraGraft will provide a new treatment option to better treat these conduits,” Dr. Martin Misfeld, of the Helios Heart Center Leipzig said in a prepared statement.

The study will evaluate patients undergoing CABG only or CABG plus valve surgeries, with baseline clinical and angiographic characteristics as well as certain post-op clinical events being recorded, the company said. Outcomes will be assessed through hospitalization, at 30 days and annually for up to 5 years.

The DuraGraft is based on the GALA technology platform licensed by Somahlution from the US Dept. of Veterans Affairs, the company said, and is a vascular graft treatment designed to maintain structural and functional integrity of the vascular graft.

“DuraGraft provides a novel treatment option to improve graft patency and improve cardiac bypass surgery outcomes. We are thrilled to be the first center in Germany to enroll patients and utilize new technologies like DuraGraft to improve CABG surgery and patient outcomes,” lead investigator Dr. Vetter said in a press release.

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Masimo wins FDA nod for pediatric O3 regional oximetry indication

Masimo (NSDQ:MASI) said today it won FDA 510(k) clearance for a pediatric indication for O3 regional oximetry with its O3 pediatric sensor.

With the extended indication, the Irvine, Calif.-based said that O3 regional oximetry monitoring will be available for pediatric patients which weigh more than 11lbs and less than 88lbs.

The technology works by using near-infared spectroscopy to continuously monitor absolute and trended regional tissue oxygen saturation in the cerebral region.

“O3 regional oximetry provides access to valuable data about cerebral oxygen saturation. With adult and pediatric trend accuracy of 3% and absolute accuracy of 4% and 5% on adults and pediatrics respectively, without controlling CO2, Masimo O3 should help clinicians build a better picture of brain oxygenation – and hopefully better outcomes for all of their patients, including pediatrics as young as three-months old,” CEO & founder Joe Kiani said in a prepared statement.

Earlier this month, Masimo said it launched the Early Warning Score system for the Root patient monitoring and connectivity hub.

The EWS system is designed to aggregate information from multiple vital signs and clinical observations to determine the potential degree of patient deterioration, the company said.

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Intuitive Surgical wins FDA nod for daVinci X platform

Intuitive Surgical (NSDQ:ISRG) said today it won FDA 510(k) clearance for its new da Vinci X robotic surgical system, with a planned release of the platform later this year.

The newly cleared da Vinci X system offers access to multiple robotic-assisted surgical technologies at a lower price than previous models, the Sunnyvale, Calif.-based company said. The system operates on the same vision cart and surgeon consoles used by the company’s flagship da Vinci Xi system.

“This new system enables access to Intuitive’s leading and proven robotic-assisted surgical technology at a lower price point. Customers around the globe have different needs from a clinical, cost and technology perspective; Intuitive’s goal is to meet those needs by providing a range of products and solutions: the da Vinci X System helps us continue to do so,” CEO Dr. Gary Guthart said in a prepared statement.

Intuitive said that the da Vinci X system allows for focused-quadrant surgery and features flexible port placement and 3D digital optics, while also including advanced instruments and accessories from its Xi system.

“The da Vinci X System is a value-oriented option for hospitals that are just starting their robotic-assisted surgical program and for our existing customers who want to expand their existing robotics programs. As customers’ needs grow, the da Vinci X System can grow with them.  The da Vinci X System enables our customers to take immediate advantage of Intuitive’s full ecosystem of support and services,” US sales senior VP Henry Charlton said in a press release.

The da Vinci X system won CE Mark approval in the European Union in April. A month earlier, Intuitive Surgical saw shares rise after the robotic surgical platform maker posted 1st quarter earnings that beat expectations on the Street.

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Why prosthetics need tactile feedback

The Rice Haptic Rocker includes a rotating arm brushing a soft rubber pad over the skin of the arm. The more a prosthetic hand closes, the more the pad stretches the skin. {Image courtesy of Brandon Martin/Rice University]

Tactile feedback enabled blindfolded test subjects to more than double their ability to determine the size of objects they grasped with a prosthetic hand, according to U.S. and Italian engineers.

“Humans have an innate sense of how the parts of their bodies are positioned, even if they can’t see them,” said Marcia O’Malley, professor of mechanical engineering at Rice University, in a university news release. “This ‘muscle sense’ is what allows people to type on a keyboard, hold a cup, throw a ball, use a brake pedal and do countless other daily tasks.”

The researchers – from Rice University and the Research Center “E.Piaggio” of the University of Pisa and the Italian Institute of Technology – will present their findings June 7 at the World Haptics 2017 conference in Fürstenfeldbruck, Germany.

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

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3D printing could make bionic skin possible: Here’s how

This diagram shows the 3D printing of touch sensors onto a model hand. [Image courtesy of University of Minnesota]

University of Minnesota researchers 3D printed tiny stretchable electronic sensory devices that could enable bionic skin for surgical robots – or a new class of wearables directly printed onto human skin.

Their work appeared May 5 in the journal Advanced Materials.

“This stretchable electronic fabric we developed has many practical uses,” said Michael McAlpine, a University of Minnesota mechanical engineering associate professor and lead researcher on the study, in a U of M news release.

“Putting this type of ‘bionic skin’ on surgical robots would give surgeons the ability to actually feel during minimally invasive surgeries, which would make surgery easier instead of just using cameras like they do now. These sensors could also make it easier for other robots to walk and interact with their environment,” McAlpine said.

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

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InVivo adds Reeve Foundation database to Contempo registry study

InVivo Therapeutics (NSDQ:NVIV) said today it will integrate data from the Christopher & Dana Reeve Foundation’s North American Clinical Trials Network Registry in the Contempo registry study which is complementing its ongoing Inspire study.

The Cambridge, Mass.-based company said that the Contempo study looks to provide comprehensive natural history benchmarks for the Inspire study of its Neuro-Spinal Scaffold, an implant designed to act as a physical substrate for nerve sprouting after acute spinal cord injuries.

The NACTN registry is derived from a network of academic neurosurigcal departments and hospitals with a focus on spinal cord injuries, especially acute injuries, the company said. The registry includes acute patient data, including pre and post-operative data, post-injury complications and treatments, MRI data and follow-up neurological exam data.

“The NACTN Registry was developed in large part to aid in the interpretation of SCI clinical trial results. This is the first time that the registry will be used with a partner in industry, and I believe that the registry will provide a valuable benchmark for analysis of Inspire results,” Contempo Registry principal investigator & InVivo scientific advisory board member Dr. James Guest said in a prepared statement.

InVivo said that Contempo registry study and Inspire study data will provide appropriate evidence for the safety and probable benefit required by Humanitarian Device Exemption approval process, with results slated to be submitted to support HDE approval.

“We are grateful for the care and vigilance that NACTN has put into developing an impressively thorough, curated database over many years. The inclusion of the NACTN Registry substantially increases the strength of the Contempo registry study. We look forward to completing the Inspire study and the Contempo registry study and submitting the results together in 2018 in an application for HDE approval of the Neuro-Spinal Scaffold,” CEO Mark Perrin said in a press release.

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BioElectronic launches migraine study for ActiPatch pulsed shortwave therapy

Non-invasive electroceutical developer BioElectronics said today it launched a clinical study of its ActiPatch, examining the use of the device for treating migraines.

The ActiPatch is a series of patches or wraps which use electromagnetic pulse therapy to treat chronic pain, according to the Frederick, Md.-based company’s website.

In the randomized, double-blinded placebo controlled study, investigators aim to examine the efficacy of the ActiPatch in preventing chronic migraine attacks.

A total of 48 patients are slated to be enrolled in the trial, which will take place in 2, 4-week periods, with the 1st serving as a run-in period with no therapy and a treatment or placebo period for the rest of the subjects.

“Migraine is the fastest growing category in the chronic pain market, but existing therapies work poorly. A successful study will help in seeking a non-prescription indication for the prevention of migraines, from the FDA,” product dev VP Sree Koneru said in a press release.

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

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.

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5. Your fitness tracker could be misleading you

Your heart rate may be accurate on your fitness tracker, but the number of calories burned is significantly wrong, according to new research from Stanford University.

The researchers suggest that although the heart rate measurements are pretty much accurate, energy expenditure measurements are probably significantly wrong. Read more

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4. Sirtex hops after Aussie court dismisses shareholders injunction

Sirtex Medical said yesterday that Australia’s Federal Court dismissed a lawsuit filed by shareholders alleging it breached continuous disclosure obligations and engaged in misleading and deceptive conduct.

The lawsuit alleges that the double-digit growth outlook for dose sales for its fiscal year 2017, which the company announced on Aug. 24 last year, “has no reasonable grounds.” Yesterday the Australian company said the Federal Court dismissed the shareholders’ bid for an injunction, freeing Sirtex to plan a June 7 share repurchasing plan worth $22.4 million (A$30 million). Read more

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3. Stimwave Tech wins CE Mark for SandShark neurostim anchor system

Stimwave Technologies won CE Mark approval for its SandShark percutaneous injectable anchor system designed to be used in conjunction with its wireless neurostimulator devices to treat chronic pain, according to its distributor Freedom Neuro BV.

The SandShark anchor system is designed to affix the neurostimulator device once the stimulator has been injected. The system slides down over the device and presses the anchor into the tissue, where it is secured to the stimulator and the stimulator is secured to surrounding tissue to prevent migration. Read more

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2. Potential Alcon sale worries Novartis investors

Novartis CEO Joe Jimenez’s consideration of the sale of the Alcon subsidiary has investors worried that the influx of cash – Alcon’s surgical devices and contact lens business could fetch as much as $35 billion – will result in another misguided acquisition.

The Swiss drugmaker paid $52 million for Alcon in 2011, but the division’s sales and earnings have been on the schneid for the past 2 years, prompting Jimenez to mull a sale. Also in play is a $ 14 billion stake in pharma rival Roche and a $10 billion over-the-counter drug joint venture with GlaxoSmithKline. Novartis faces a March 2018 deadline to exercise its put option for its 36.5%, with GSK said to be a willing buyer. Read more

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1. Medtronic increases stake in Saluda Medical

Saluda Medical said it raised nearly $40 million (A$53 million) for the Evoke closed-loop neuromodulation device it’s developing to treat axial back pain.

The round was led by a new investor, GlaxoSmithKline‘s Action Potential Venture Capital, joined by existing backer Medtronic, Artarmon, Australia- and Bloomington, Minn.-based Saluda said. Read more

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Novo Nordisk seeks to include cardiovascular data in Tresiba insulin label

Novo Nordisk (NYSE:NVO) said today that it submitted a supplemental application to the FDA, asking to include cardiovascular data on the label of its Tresiba insulin degludec.

The Danish insulin-maker asked to include data specifically from the Devote trial, which evaluated the cardiovascular safety of Tresiba compared to insulin glargine in patients with Type II diabetes.

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

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Mallinckrodt faces probe over price hikes for injectable pain-killer

Sen. Claire McCaskill (D-Mo.) penned a letter to Mallinckrodt Pharmaceuticals (NYSE:MNK) last week, probing for details about the company’s pricing strategies for its injectable pain-killer, Ofirmev.

Mallinckrodt acquired Ofirmev in 2014, when it bought Cadence Pharmaceuticals in a $1.4 billion deal. In May of that year, Mallinckrodt hiked the pain-killer’s list price from $14.75 per vial to $35.40 per vial.

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

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FDA labels Zimmer Biomet SpF spinal fusion stimulator recall as Class I

The FDA today released information on a Zimmer Biomet (NYSE:ZBH) recall of select SpF Plus-Mini and SpF XL IIB implantable spinal fusion stimulators over issues with potentially harmful chemicals which could be toxic to tissues and organs.

Class I recall designations, the agency’s most serious classification of recall, are used when there is a reasonable probability that product use could cause serious adverse health consequences or death.

The SpF Plus-Mini and SpF XL IIB implantable spinal fusion stimulators are designed to be used to increase the possibility of permanently connecting 2 or more bones, and are implanted in a patient’s back to provide constant electrical stimulation to the surgical site, the Agency wrote.

The company is recalling the devices due to “higher than allowed levels of potential harmful chemicals, which may be toxic to tissues and organs,” according to the FDA release.

The company said that they identified the issues during a routine monitoring procedure, and that use of an affected product could cause serious adverse health consequences including chronic infections, long-term hospitalizations requiring additional procedures, paralysis or death.

The recall affects approximately 33 select SpF Plus-Mini and SpF XL IIB implantable spinal fusion stimulators manufactured between Oct. 11, 2016 and Jan. 18, 2017 and distributed between March 28, 2017 and April 6, 2017. A total of 22 different serial numbers were identified for the SpF-XL IIB, and 11 with the SpF-Plus.

Zimmer Biomet instructed customers with the devices to quarantine all affected units and that a company rep would contact them to collect and remove them.

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Robotic surgery: We’ve got design advice for you

There are a handful of companies in the robotic surgical space. But that is about to change. There is ample evidence that the robotic surgical device market is going to explode in the next 3 to 5 years.

We recently spoke with Todd Pope, CEO of TransEnterix who said there is a lot of opportunity in the market: “If you look at Europe and the U.S., there are 4 million open procedures and 6 million laparoscopic procedures done each year.”

Pope noted that even critics of robotic surgery agree that the technology space is growing. “I don’t think there is any analyst that doesn’t have the market growing by 300–400% over the next 5 to 7 years. “Pope said he is looking forward to others being in the market because it will drive more interest, more applications and more opportunity to find out where a robotic surgical application can make a difference and expand markets.

But the robotic surgical device market has a high barrier to entry – and the big competitors have more than a decade of experience under their belts. With that in mind, we thought it might be important to share some advice to those firms thinking about entering the fray.

See 5 Steps to Robotic Surgical Design at our sister site, Medical Design & Outsourcing

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This nanofiber device can hear cells moving

This is an artist’s illustration of nano optical fibers detecting femtonewton-scale forces produced by swimming bacteria. [Image from Rhett S. Miller/UC Regents]

A new miniature nanofiber device created by engineers at the University of California at San Diego is sensitive enough that it can feel bacteria swimming and can hear heart muscle cells beating.

The device is 100 times thinner than a human hair and is made of optical fiber. It is designed to be able to detect forces as small as 160 fN if put in a live Helicobacter pylori bacteria solution. The device can also hear sounds at –30 dB, which is 1,000 times below what humans can hear.

“This work could open up new doors to track small interactions and changes that couldn’t be tracked before,” said Donald Sirbuly, a nanoengineering professor at UCSD Jacobs School of Engineering and leader of the study, in a press release.

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

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FDA clears Ra Medical’s Dabra areteriosclerosis laser

Medical excimer laser developer Ra Medical said it won FDA 510(k) clearance for its Dabra system designed to treat patients with peripheral artery disease.

The Carlsbad, Calif.-based company said that the system is designed to destroy arteriosclerotic blockages through the use of radiation ablation, touting the device and associated procedures as cost and time saving.

“Dabra’s pivotal study demonstrated 95% success without any clinically significant adverse events. Furthermore, the Dabra Catheter is unique in its ability to cross Chronic Total Occlusions without having to cross the lesion with a wire, and it also debulks and modifies arterial blockages, making it an invaluable clinical tool,” Dr. Ehtisham Mahmud of the UC San Diego School of Medicine

“Dabra is what we have been waiting for to better treat our patients. It is a two-in-one. You cross the blockage and remove the plaque from the artery. It is safe, because it stays in the patient’s true lumen and does not go subintimal or perforate – common complications of other devices – and it’s effective on all types of lesions. It is revolutionary wireless technology and effective in cases in which other devices have failed. Dabra should be part of every cardiovascular catheter lab’s armentarium,” Dr. Athar Ansari of the California Heart & Vascular Clinic said in a prepared statement.

“Dabra’s U.S. market clearance is the realization of more than a decade of dedication to the pursuit of delivering a more effective, safer and less expensive way to remove blockages from arteries to save limbs and, ultimately, save lives. To do so, we built Ra Medical Systems and pioneered our cost-effective, small and portable Pharos Excimer Laser for dermatological diseases, thereby creating our company infrastructure and self-funding the development of Dabra. We built our company in a way that no other cardiovascular company has been created, and we will continue delivering groundbreaking catheters, lasers and other devices to treat unmet medical needs in cardiovascular, dermatology and other therapeutic areas of medicine,” co-founder & CEO Dean Irwin said in a press release.

Last October, Ra Medical said it won CE Mark approval in the European Union for both its Dabra artherectomy catheter system and its Pharos excimer laser designed to treat skin diseases.

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Intensity Therapeutics begins human testing of intratumoral cancer drug

Intensity Therapeutics said today that the 1st patient was treated in a Phase I/II trial of its intratumorally-administered cancer therapy, INT230-6.

The company’s plans to evaluate the safety of its cancer-killing agent in patients with tumors that are treated at the surface of the skin, including breast cancer and melanoma. Intensity Therapeutics also plans to study INT230-6 in patients with deep tumors.

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

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Your fitness tracker could be misleading you

Danielle, Kirsh, Assistant Editor

Study participants wore the fitness trackers while walking or running on a treadmill and while riding an exercise bike. [Image from Stanford University]

Your heart rate may be accurate on your fitness tracker, but the number of calories burned is significantly wrong, according to new research from Stanford University.

The researchers suggest that although the heart rate measurements are pretty much accurate, energy expenditure measurements are probably significantly wrong.

Apple Watch, Basis Peak, Fitbit Surge, Microsoft Band, Mio Alpha 2, PulseOn and Samsung Gear S2 were tested in a group of 60 people. The results showed that measuring heart rate had an error rate of less than 5% on 6 of the devices. Some measurements were more accurate than others while skin color and body mass index affected measurements.

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

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