News

World's largest orthopedics contract manufacturer closing two plants

Tecomet is slated to close plants in New Bedford, MA, and Avilla, IN, at a cost of more than 300 jobs, a regulatory filing shows.

Sony sells off half its Olympus stake amid duodenoscope pushback

As Olympus faces mounting backlash for endoscope devices linked to the recent superbug outbreaks, Sony, the company's largest shareholder, is selling off half its stake to raise funds for strategic investments.

Boston Scientific recalls its Expel biliary catheters after complaints of fragmentation

Boston Scientific is initiating a recall of some of its biliary drainage catheters after 11 reports of device fragmentation, according to the FDA's recall database. The recall is labeled Class II, meaning the device "may cause temporary or medically reversible adverse health consequences."

Researchers develop bioplastic that can combat infections from devices

Infections caused by artificial joints and other devices can lead to sepsis, which is often fatal. Now researchers say they have developed a bioplastic that is resistant to bacteria and could be used to combat infections from devices like wound dressings and catheters.

Medtronic gets FDA go-ahead to use CoreValve in additional heart patients

In a big win for Medtronic, the FDA expanded the indication of the company's transaortic valve replacement device permission to include replacement of patients' failed artificial aortic valve. The novel use of the device gives Medtronic a leg up on rival Edwards, whose Sapien XT TAVR does not have permission to be used for what's called "valve-in-valve" replacement.

Quintiles, Quest create JV to offer clinical trial lab services, companion diagnostics

Quest Diagnostics is partnering with contract research organization Quintiles to create a joint venture to provide a range of clinical trial services to biopharmas including laboratory testing and patient recruitment and retention as well as development and commercialization of companion diagnostics.

VA starts trial of mobile app to help manage PTSD symptoms

The Department of Veterans Affairs is assessing the efficacy of a mobile application to teach patients to self-manage post-traumatic stress disorder (PTSD). The trial is set up to determine the relative advantage of the app in combination with physician support versus its use alone.

Hansen eyes expansion for robotic surgery system with Chinese distribution deal

California's Hansen Medical inked a distribution deal with a Chinese medical device company for its intravascular robotic system, a feather in Hansen's cap as it looks to expand commercialization for its device.

Philips sells LED, automotive lighting for almost $3B, readies to reinvest in HealthTech

Royal Philips disclosed a deal to sell off 80.1% of its interest in its LED component and Automotive lighting business for $2.8 billion with an additional contingent payment for up to $100 million. This deal will free up cash for Philips to invest in HealthTech, which combines its healthcare and consumer groups.

Olympus settles accounting scandal as it struggles to address duodenoscope difficulties

Olympus will pay as much as 11 billion yen ($92 million) to settle two lawsuits based in a 2011 accounting scandal. This comes just as the camera and medical imaging company has been identified as one of several companies whose dirty duodenoscopes have infected some patients with antibiotic-resistant bacteria.

Medical device cybersecurity expert says better 'cybersecurity hygiene' needed

The director of the University of Michigan's center for medical device cybersecurity called for better "cybersecurity hygiene" last week during a roundtable discussion in Washington, DC, sponsored by the New America Foundation.

Philips brings in former Hologic CEO to head imaging biz in ongoing HealthTech revamp

Royal Philips has hired Robert Cascella to head up its imaging businesses, including the newly acquired assets from catheter-based imaging company Volcano. He was the former president and CEO of Hologic, where he held executive positions for about a decade.

Med tech represents on Forbes' list of 400 richest

The device industry is the source of wealth for 10 of the people on Forbes' annual list of the 400 richest people in America.

Nanorobot shows promise as humidity sensor thanks to use of bacterial spore

Researchers at the University of Illinois-Chicago have developed a nanoparticle-based robot that can detect humidity thanks to the use of bacterial spores and a form of carbon known as graphene.

FDA taking 'very light touch' in smartphone and digital device regulation

As med tech companies zero in on digital technology for healthcare monitoring, the FDA said it is allowing more room for innovation before taking a heavy hand in regulation.

Zimmer to divest three businesses to satisfy EU regulators in Biomet acquisition

The European Commission is concerned that the $13.4 billion acquisition of Biomet by Zimmer will result in price increases due to reduced competition in orthopedic implants in the European Economic Area. In order to allay these fears, Zimmer has agreed to divest three businesses in specific European markets.

Devicemaker, CEO, take on FDA over 'free speech' of sales pitch

Minneapolis-based Vascular Solutions and its chief executive are taking on the FDA's power over what device makers and other healthcare manufacturers can and cannot say when making sales pitches to doctors.

Outgoing FDA commissioner highlights record, outlines industry future in farewell remarks

Margaret Hamburg gave a forceful recounting of her tenure at the agency in her final formal remarks as outgoing FDA commissioner. The March 27 speech at the National Press Club in Washington, DC, seemed designed to hand the baton off smoothly to FDA Chief Scientist Stephen Ostroff, who has been widely cited as her presumptive replacement.

Study: OvaScience fertility treatment improves pregnancy rates, but Wall Street remains skeptical

Pregnancy rates were higher than might normally be expected with in vitro fertilization in the latest data for the Augment Fertility Treatment from OvaScience. But fertilization and blastocyst formation weren't particularly improved. Even the pregnancy rates don't look quite so good--when you consider all the patients who originally enrolled, noted a Leerink analyst.

Federal Trade Commission cracking down on questionable mobile medical apps

Although the FDA is taking a hands-off attitude toward regulating new forms of health information technology, the Federal Trade Commission has stepped up enforcement of those app makers that make false or misleading claims.