News

Titan Spine offers first spine implant warranty

Titan Spine yesterday announced that it is becoming the first spine implant manufacturer to offer a warranty on its products. The 5-year warranty of its Endoskeleton line of spinal interbody fusion devices is the orthopedics industry's second product guarantee, joining Biomet's lifetime warranty of its Oxford Partial Knee. 

Israeli startup develops hand-held device for medical marijuana

As medical marijuana gains ground as a treatment for chronic pain, Israeli startup Syqe Medical is developing a hand-held device that yields more controlled cannabis dosage and provides an alternative to traditional delivery methods.

Study: Fecal incontinence implants reduce weekly incontinence episodes in women

A study by American Medical Systems, a unit of Endo Health Solutions, showed that the company's fecal incontinence implant product reduced by half the number of weekly bowel leakage incidents in nearly 70% of the female participants.

Stent developer Tryton gets $20M to complete FDA submission, market in EU

Startup Tryton Medical has raised $20 million in venture capital to submit its side branch stent to the FDA and market it in Europe. It hopes to have the first coronary stent approved to treat bifurcation lesions in the U.S. Nearly one-third of patients undergoing coronary angioplasty have bifurcation lesions, according to the company.

Abbott diagnostic enables faster, cheaper infection treatment

A new study suggests that a diagnostic from Abbott Laboratories offers a more accurate and faster diagnosis of the cause of blood-related infections. The in vitro diagnostic is expected to receive a CE mark in the coming months.

EU creates €1B fund for research on the use of graphene

The European Union is betting heavily on graphene, a potential material of the future with several med tech applications, via a €1 billion ($1.3 billion) research fund dubbed the Graphene Flagship.

First Dx for kidney failure approved by FDA

The FDA cleared the first and only diagnostic for acute kidney injury today, Astute Medical announced. A recent study found that hospitalized patients who got AKI had a 30% mortality rate at one year, twice that of a heart attack.

Top digital health startups taking the stage at TEDMED

This year, TEDMED has a series of digital health startup company presentations as part of its Hive collective.

J&J ordered to fork over $3M in vaginal mesh case

Johnson & Johnson's Ethicon unit lost a battle in its ongoing vaginal mesh litigation as a federal jury in West Virginia ordered the company to pay $3.27 million to a woman who claimed the device caused undue pain and serious side effects.

FDA clears Otoharmonic's iPad/iPod app to treat tinnitus

The FDA has given clearance to startup Otoharmonics for its iPad and iPod Touch application that uses sound therapy to teach the brain to ignore persistent ringing caused by tinnitus.

Medtronic receives CE mark for upgraded CoreValve TAVR

Medtronic said that its recent CE mark for its CoreValve Evolut R System for transcatheter aortic valve implantation paves the way for the option to recapture or reposition artificial valves during heart surgery. The new feature is an advance in the relatively new arena of less-invasive heart surgery for patients who cannot withstand the rigors of open heart procedures.

FDA-approved iPad blood loss app has first use in cesarean surgeries

A recently approved iPad app has been put to use to measure blood loss during cesarean section births. The app is being used as a substitute for evaluation techniques, such as sponge weighing, in cesarean surgeries at Magee-Womens Hospital in Pittsburgh, PA.

Fractyl raises $40M for diabetes treatment via endoscopic surgery

Endoscopic surgery isn't usually associated with diabetes, but Fractyl Laboratories yesterday announced encouraging clinical trial results for its endoscopic procedure to treat Type 2 diabetes and revealed a $40 million Series C financing round led by investment firm Mithril Capital Management.

Med tech startups flourish as access to IT gets cheaper, easier

Med tech is successfully navigating the plethora of alternative prototype capabilities, like 3-D printing, that were not available in previous decades.

Israeli colon capsule maker bucks M&A trend with plans for $60M IPO

Amid a wave of med tech M&A, Israeli colon capsule maker Check-Cap is bucking the trend and heading to market with plans for a $60 million IPO.

Researchers diagnose atrial fibrillation via webcam

Atrial fibrillation causes uneven blood flow, which results in subtle changes in facial skin color. Researchers were able to use that to diagnose AF patients in a small pilot study by using video of a person's face in conjunction with a software analysis of skin color.

The metal-on-metal hip legal saga round one (of 6,000?): J&J vs. Herlihy-Paoli

Johnson & Johnson squared off with aggrieved metal-on-metal hip customer Kathleen Herlihy-Paoli in a case that the plaintiffs says could lead to a $5 billion-plus payout. Herlihy-Paoli's claims that the hips leaked metal into her bloodstream, leading to an infection that required the artificial hip to be removed.  

NEJM op-ed calls for more sham-controlled device trials

Use of nontherapeutic "sham" control tests in clinical trials of medical devices isn't always easy or cheap, but one perspective piece in The New England Journal of Medicine argues in favor of the practice in order to better test effectiveness of medical devices and procedures. 

Propeller Health gets $14.5M Series B for smart inhaler, app combo

It can be difficult for patients with respiratory ailments to track their use of rescue medications. An inhaler sensor from Propeller Health does just that--serving as a remote monitor of drug use and feeding into a mobile app that tracks and analyzes medication use. The app even predicts when patients are likely to have difficulty, based on prior experience, and can be used to ensure proper inhaler usage, a common issue.

AdvaMed says FDA proposed rule would result in more PMAs, device reclassifications

The device industry is awaiting the finalization of the FDA's rule on medical device classification procedures, and will be combing it for the requested changes from the March 2014 proposed rule. More comments asking for an easing of the regulatory burden may be forthcoming, for the FDA extended the public comment period to Sept. 22, according to a notice in the June 12 Federal Register.