News

What will changes to the Sunshine Act mean for devicemakers?

Medical device manufacturers could soon be looking at additional expenses following proposed changes to the Physician Payment Sunshine Act. 

Coloplast adding 150 jobs in the U.K. to boost chronic care business

Danish devicemaker Coloplast is forging ahead with plans to add jobs in the U.K. as part of a global strategy to boost numbers for its chronic care business.

Dental implant player Nobel Biocare is the latest med tech M&A target

Nobel Biocare has confirmed it is in early discussions with potential buyers, after a Bloomberg article reported a rumored sale. The report said the company has hired Goldman Sachs to broker a transaction.

Large healthcare customers squeeze med tech supplier Owens & Minor

Medical and surgical supplier Owens & Minor is getting squeezed by unexpectedly low margins on higher-than-expected revenues as its healthcare customer base consolidates.

NEJM paper calls for more regulation of mobile health apps

With the rise of high-potential mobile health (mHealth) devices and apps, the FDA needs to add funding and tools towards regulation of the rapidly expanding industry, research experts wrote in the New England Journal of Medicine. While most mHealth devices have relatively low risk, monitoring devices that can affect core health is within FDA jurisdiction and authority.

Proteus Digital adds $52M to Series G, bringing total to $172M

In one of the largest venture capital financing of the year, Proteus Digital Health announced it raised $172 million in a Series G funding round from undisclosed institutional investors after completing a second closing.

French devicemaker faces FDA scrutiny for prostate cancer device

French devicemaker EDAP TMS SA is facing FDA scrutiny for its robotic device for prostate cancer, as regulators questioned the product's safety and efficacy in a new report. 

Wearable optical device detects diabetic complication

Complications of diabetes are more easily treated when they are found early. Researchers at National Taiwan University Hospital have developed a wearable optical device to detect diabetic autonomic neuropathy, a common diabetic complication, that could be better than existing detection methods.

Google wearables to add to planned bioinformatics database

Google isn't just searching the Internet. The company will soon search the insides of people's bodies for new biomarkers by collecting their urine, blood, saliva and tears as part of its Baseline Study initiative.

Medtronic buys surgical tech startup for up to $105M, adds to Covidien strength

With the acquisition of surgical technology company Visualase, Medtronic is further bolstering one of its own fastest growing segments--as well as a large and fast growing group for Covidien. Medtronic expects to complete its $42.9 billion acquisition of Covidien by early 2015.

Opinion: Experimental medical devices should be made available to patients

Patients should have the option to take more risks when seeking medical treatment, said Dr. Kevin Tracey in a Wall Street Journal column.

FDA final guidance modifies 510(k) rules, discourages use of multiple predicate devices

In a new final guidance issued today July 28, the FDA announced that it will frown upon the use of multiple predicate devices in 510(k) submissions, unlike when it cleared metal-on-metal hip implants, which the agency later said can damage surrounding bones and contaminate the body by releasing ions into the bloodstream.  

Medtronic teaming up with China's LifeTech to develop cardiovascular products

Medtronic is teaming up with LifeTech Scientific to manufacture and distribute cardiac devices for China's growing cardiovascular market.

Antibiotics, lab safety and disease outbreaks top CDC Director Tom Frieden's to-do list

I caught up with Dr. Tom Frieden, director of the U.S. Centers for Disease Control and Prevention, last week, prior to his address at the National Press Club in downtown Washington, DC. Other media outlets joined in later. Here are some takeaways from his speech on antibiotic resistance, as well as our conversation.

Apple poised to take a bite out of wearable device market with patent approved for iWatch

The patent for Apple's long anticipated iWatch has been approved, positioning the personal electronics giant to become one of the largest manufacturers of wearable medical devices in the world when the product is teamed with software applications that can track your heart rate and keep tabs on your blood sugar.

Registry data shows high risk of blood clot among users of Abbott's bioresorbable stent

Data from a European postmarket registry show that Abbott's Absorb BVS bioresorbable stent performs at a level similar to today's conventional drug-eluting stents on several measures, but not stent thrombosis. The risk of the stent being blocked by a blood clot was 3.4% after one year, a level of performance similar to prior generation drug-eluting stents, according to a recent EuroIntervention study.

Bard is acquisition shopping--with $1B in cash and pressure from Medtronic/Covidien merger

The Medtronic merger with Covidien could offer a particular threat to C.R. Bard's vascular business--its largest segment and one of its fastest growing. The company was clear that it's actively in the market for its own strategic acquisitions; it hasn't disclosed a sizeable deal in almost a year.

Upcoming study to dispute FDA's data on power morcellation risk

Dr. Elizabeth Pritts, director of the Wisconsin Fertility Institute, believes that the FDA is wildly overestimating the prevalence of uterine sarcoma in women undergoing hysterectomies and myomectomies for fibroid removal and worries that banning or restricting use of power morcellators will fail to address the problem, putting women undergoing the procedure at risk of upstaged cancer.

St. Jude laying off up to 270 workers in California

The second shift at St. Jude Medical's cardiology device manufacturing facility in Sylmar, a suburb of Los Angeles, is being eliminated, resulting in the loss of up 270 jobs. The layoffs will take effect July 28, reports the San Fernando Valley Business Journal. 

Covidien is popping the bubbly for positive Q3 numbers

Covidien is celebrating third quarter earnings buoyed by strong sales, with its surgical solutions unit and progress in emerging markets generating an sizeable increase in cash flow.