News

Regulators, industry, doctors dig deep to clean dirty devices following deadly outbreak

Federal regulators, physician groups and medical device manufacturers are wasting little time looking for both quick and long-term fixes to ensure duodenoscopes are properly cleaned and sterilized for reuse. The scramble comes following highly publicized outbreaks of an antibiotic-resistant superbug dubbed CRE (carbapenem-resistant Enterobacteriaceae).

ReWalk Robotics stumbles 6 months after IPO

ReWalk Robotics is encountering a few stumbling blocks 6 months after making its NASDAQ debut, with shares taking a hit in light of widening net losses and investor skepticism about the market for its flagship robotic exoskeleton device.

Study: Car breathalyzer could save 59K U.S. lives in 15 years

If breathalyzers were installed in every U.S. car, that could save 59,000 lives and $343 million over a 15-year period, according to a University of Michigan study. But while the technology to prevent a person from driving drunk currently is available as an add-on, it's not clear when, or even if, it will become a standard car feature.

InterVene raises $5.9M to transform severe venous insufficiency treatment

InterVene has raised $5.9 million to advance its minimally invasive approach to chronic venous insufficiency. Its catheter-based approach creates new valves out of the patient's native vein wall tissue. If successful, this could offer an innovative curative approach to patients that are often facing long-term management of the condition.

Sebacia reveals positive data for acne-fighting gold microparticle device

Dermatology outfit Sebacia is touting promising results for its acne-treating technology from two recent clinical studies that show its gold microparticles significantly reduced acne in patients.

 

Philips to help fund HealthTech refocus with 2016 lighting biz IPO

Royal Philips plans an IPO for its lighting solutions business during the first half of next year. It's slated to offer only a minority interest in the IPO, which will be followed subsequently by one or more follow-on offerings intended to fully divest Philips.

GE tech hub develops innovative handheld probe for bedsore monitoring

As the med tech industry turns its attention to devices that can treat and prevent bedsores, a team of GE researchers is developing an innovative handheld probe that can prevent the sores, or pressure ulcers, from forming during hospital stays.

Kleiner Perkins' Auxogyn gets $34M to better identify an IVF embryo's odds

Last June, Auxogyn's Eeva System was the first to be cleared by FDA to aid in IVF embryo selection in combination with traditional morphology. Now the startup has raised $34.3 million, out of a planned $41 million, financing round to start commercializing this test, according to an SEC filing.

New app for helping those with autism communicate debuts

Pyramid Education Consultants announced the launch of its new mobile app, PECS IV+, to help autistic people communicate by forming sentence structures with pictures.

Wearable devices on display at inaugural med tech expo in Texas

The South by Southwest Interactive conference in Austin, TX, is a poor man's version of the grand Consumer Electronics Show in Las Vegas, but it still had a rich array of wearable healthcare-related technology on display during the event's first-ever med tech expo.

Svelte Medical raises $16M for smaller drug-eluting coronary stent

Svelte Medical is trying to slenderize the coronary stent. It's raised $16 million to help get to market with its transradial cardiac stent. It has a smaller profile that makes it less invasive and allows it to be inserted via an artery in the wrist rather than the traditional route via the groin.

 

Jury clears former NFL player and co-CEO of fraudulent devicemaker on most serious charges

A jury just cleared a retired, Super Bowl winning wide receiver of charges of fraud related to a plan to pump up the stock of Heart Tronics, a cardiology device company.

Canon BioMedical makes first move with rapid DNA, drug metabolism diagnostic startup

Canon U.S.A. just announced its BioMedical subsidiary earlier this month. Now it's made its first med tech deal, an investment in Canadian diagnostic startup Spartan Bioscience, offering a glimpse of what to expect in the future from this new direction for the digital imaging company.

Boston Scientific subsidiary hit with $50M gender discrimination suit

A California-based Boston Scientific company was slapped with a $50 million gender discrimination suit from a former manager and a current executive who claim the devicemaker unfairly favors its male employees by paying them higher salaries and assigning them to more profitable territories.

Medtronic's stent for peripheral artery disease wins expanded indication from FDA

After staving off Treasury Department rules, angry politicians and antitrust regulators, Medtronic is earning early victories from its $50 billion mega-acquisition of Covidien. The company announced that the former rival's Protégé GPS peripheral stent for treating peripheral artery disease now has the FDA's blessing to be used against lesions in the common and external iliac arteries, located in the pelvis.

FDA will discuss challenges and opportunities of robotic surgery at public meeting this summer

The FDA is putting robot assisted surgery in the spotlight this summer. 

New indoor color-blindness-correcting glasses launched

EnChroma launched a new, indoor version of its color-blindness-correcting glasses for those suffering from red-green color blindness.

Micro-cap Bovie Medical raises $10.6M to back plasma-based surgical tool

Shares of Bovie Medical skidded a further 2% on news that the company had raised about $10.6 million in a follow-on offering. That's an impressive feat given that its market cap is a scant $44 million.

UPDATED: Medtronic steerable sheath recalled, deemed potentially deadly by the FDA

The FDA just labeled the recall of Medtronic's 10 French FlexCath Select Steerable Sheath as a class I recall. This means there is a reasonable probability that the device "will cause serious adverse health consequences or death.

American College of Cardiology meeting supportive of ablation to treat warning sign of stroke

In a win for cardiac ablation device makers like Johnson & Johnson's Biosense Webster and AtriCure, two studies presented at the American College of Cardiology's annual meeting in San Diego concluded that performing atrial fibrillation ablation improves outcomes.