News

Two U.S. hospitals to test startup's novel medical device malware detection software

Startup Virta Laboratories will beta-test its medical device malware monitoring software at two major U.S. hospitals, according to a report from U.K. publication The Register from the recent information security RSA conference in San Francisco, CA.

GE backs depression neurostim startup Neuronetics in $34M Series F round

Neuronetics has closed a $34.3 million Series F round to further commercialize its NeuroStar transcranial magnetic stimulation therapy system to treat drug-resistant major depressive disorder (MDD), as well as to fund a registration study for adolescent use of the device. NeuroStar was cleared by FDA in 2008 to treat MDD, but the company said it's just recently been gaining traction with payers.

Sorin touts study showing its flexible implant for mitral valve disease is better than Medtronic's

At last week's mitral valve disease conference in New York City, Italy's Sorin Group presented data showing improved outcomes with its annuloplasty ring in heart failure patients, as compared to the results from patients with rings made by rivals Medtronic and St. Jude Medical.

Spectranetics shares slump as the medical laser maker snips forecast

Shares of Spectranetics, the maker of medical lasers, hit a 6-month low in heavy trading after it reported lower quarterly earnings and trimmed its forecast for the year because of increased competition from other drug-coated balloon products and its own R&D spending.

Boston Scientific loses bid to throw out claims tied to vaginal mesh device

Boston Scientific is facing more bad news in its ongoing vaginal mesh saga, as a federal judge rejected the company's bid to toss out claims for damages in one of its more than 15,000 product liability suits.

Mobile health apps haul in $220M in Q1 funding

Mobile health apps raised $220 million in Q1 2015. And the financial backers were ambitious. Fitness, nutrition and wellness apps accounted for only 17% of the total, while advanced apps to treat chronic conditions and illnesses took 77% of the pie.

Device companies team up to launch Asia Pacific Medical Technology Association in Singapore

Industry bigwigs are teaming up to create the first medical device industry association focused solely on Asia. The member companies of the just-launched Asia Pacific Medical Technology Association include Abbott, Baxter, B. Braun, Becton Dickinson, Boston Scientific, Cardinal Health, GE Healthcare, Johnson & Johnson, Medtronic, Philips, Siemens, Stryker and Zimmer.

Speakers at Senate hearing on medical device tax say it is killing jobs and innovation

The U.S. Senate Committee on Finance is considering the infamous 2.3% medical device tax today during the hearing: "A Fresh Look at the Impact of the Medical Device Tax on Jobs, Innovation, and Patients." The Republicans introduced a bill to repeal the medical device tax on day one of their takeover of Congress in January 2015, and prior to that they brought up the issue during negotiations to end the 2013 government shutdown and raise the federal debt ceiling on government borrowing, demonstrating the ferocity with which the party is pursuing a repeal.

FDA deems all 4,000+ of troubled Maquet's left atrial appendage closure devices potentially deadly, announces major recall

On the heels of a permanent injunction from the Department of Justice that resulted in the cease of manufacturing at one of its facilities, the suspension of 5 of Germany's Maquet Holding's devices from the market and a $6 million fine, the FDA announced the recall of all 4,154 units of its stroke-fighting TigerPaw System II left atrial appendage closure device.

Bard's Lutonix drug-coated balloons help lift Q1 earnings

C.R. Bard reported increased first-quarter sales as its Lutonix drug-coated balloons used to treat peripheral artery disease (PAD) in outpatients help lift the company's earnings.

Low-cost smart syringe shoots for reduced disease transmission

As the industry turns its attention to smart needles that help reduce disease transmission, one device offers a more affordable option: the K1 auto-disable syringe. The K1 costs between four and 5 cents, whereas traditional syringes can run anywhere from three to four cents and single-use syringes can cost double that.

Tissue engineering is the next frontier of 3-D printing

Advances in 3-D printing were on display at last week's Inside 3D Printing Conference in New York City. Among the attendees were Nin Desai, the CEO of NIN Ventures, which is betting on 3-D printing in the medical space, especially tissue engineering. "The biggest 5 sectors in the medical space are bracing, hip and knee replacements, hearing aids [and] dental and tissue engineering," she said. "The most underrated sector currently is tissue engineering. It's the newest."

Medtronic facing new wrongful death lawsuit over failed insulin pump in wake of 2009 recall

The executor of the will of a New Jersey man who died of a night-time diabetes attack is suing Medtronic for the alleged failure of its MiniMed insulin pump and infusion set.

Inspire Medical expands reach for sleep apnea implant at military and VA hospitals

Inspire Medical Systems snagged approval to provide its implantable sleep apnea device at U.S. military and veterans' hospitals, a win for the company as it looks to ramp up commercialization for the product and gain coveted reimbursement.

Siemens gains add-on breast tomosynthesis FDA approval, as startup files first PMA for computer-aided detection

Just as the latest breast tomosynthesis equipment option has made it through the FDA with an approval for Siemens, startup VuComp has submitted its own PMA to gain approval for its computer-aided detection software for digital breast tomosynthesis images.

Ahead of Apple Watch launch, hearing aid company reveals its app development experience

The success (or failure) of third-party app developers will determine whether the Apple Watch meets the company's med tech ambitions following tomorrow's official launch.

Diabetes device sales bounce back at Abbott with FreeStyle Libre

Diabetes care at Abbott Laboratories has returned to sales growth as ex-U.S. sales of its new FreeStyle Libre kick in and the impact of diabetes device reimbursement reductions dropped off the books. The continuous glucose monitor eliminates regular finger sticks and has surpassed the company's sales expectations.

St. Jude aims for Axium approval before year-end, with robust neuromodulation growth in 2016

St. Jude Medical took the opportunity on its April 22 earnings call to flesh out the logic and expectations behind its purchase of Spinal Modulation for a total of at least $215 million (plus undisclosed approval and revenue milestones) that was revealed earlier this week. Neuromodulation is one of its three pillars for achieving 4% to 5% revenue growth this year--and the company anticipates that in 2016 neuromodulation will be even stronger.

FDA issues new guidelines on acceptance of data from overseas clinical trials

The FDA issued guidelines on its acceptance of medical device clinical data from overseas studies in a just-issued draft guidance, saying the "increasing globalization of clinical trials presents challenges to both US and foreign regulators."

Swedish med tech player Getinge gets $172M loan from EU bank to develop new devices

Swedish medical technology company Getinge has secured a €160 million loan ($172 million) to support its research and development activities from the European Investment Bank under a program tasked with invigorating R&D activity in the EU.