News

China investigating its head of device supervision as part of growing corruption crackdown

In a move that will send chills up the spine of all members of the device world, China announced that it is investigating Tong Min, who's in charge of medical device supervision at the China Food and Drug Administration, or CFDA.

DOJ slaps Olympus with a subpoena over dirty duodenoscopes

The U.S. Department of Justice subpoenaed Olympus Medical Systems in the latest portion of the long-unfurling saga of how and why duodenoscopes routinely used in colonoscopies and upper gastrointestinal tract examinations have continued to be a problematic source for the spread of deadly bacteria for years.

JAMA: Astute Medical Dx assists in acute kidney injury prevention

Fierce 15 member Astute Medical pointed to a study in The Journal of the American Medical Association that used its NephroCheck diagnostic of acute kidney injury to demonstrate that the life-threatening condition can be kept in check by what's known as remote ischemic preconditioning.

Zimmer to divest three U.S. businesses to appease FTC, hit mid-June Biomet acquisition close

Zimmer already has clearances from regulators in Europe and Japan for its proposed $13.4 billion acquisition of Biomet. Now it's close to gaining the go-ahead from the U.S. Federal Trade Commission. Zimmer has disclosed that it has secured buyers for three U.S. businesses to satisfy FTC requests: Zimmer Unicompartmental High-Flex Knee System assets, Biomet Discovery Elbow System assets and Cobalt bone cement assets.

BD aims to sell its recently acquired surgical instruments biz for $500M

On the heels of its $12 billion purchase of CareFusion, Becton Dickinson is looking for suitors for the acquired company's V. Mueller line of surgical instruments.

Nonprofit leads $17.5M round for medical image exchange startup LifeImage

Cambia Health Solutions, a Portland, OR-based nonprofit, has led a $17.5 million financing for medical image network LifeImage--which claims to be the largest, most utilized network for exchanging medical images.

Boston Scientific slapped with $100M verdict in vaginal mesh suit

Boston Scientific was ordered to fork over $100 million to a woman who alleged the company's vaginal mesh products caused her undue pain and suffering, a stinging blow for the device giant as it moves to settle claims with patients.

China hikes regulatory fees for devices, drugs

China has steeply raised the fees it requires to submit a medical device or a drug to the China Food and Drug Administration to more than $100,000. The move is expected to provide better funding for the regulator, which is struggling with a huge backlog of products awaiting approval. 

Deerfield backs startup with $10M for its hemodialysis vascular access implant

Vital Access has secured a $10 million credit facility from Deerfield Management to expand marketing of its FDA-cleared implant to make it easier to access the vascular system of end-stage renal disease patients for hemodialysis. The cash is also intended to invest in additional vascular access products that might stem from the company's platform.

Startup StimGuard has positive early data for injectable incontinence micro-stimulator as it heads into U.S. pivotal trial

StimGuard reported pilot data for its novel wireless microtechnology injectable tibial stimulator for the relief of overactive bladder. The move comes just as the startup plans to launch a U.S. pivotal trial for the device this summer.

France's Labco sells to Cinven for $1.3B after pumping brakes on IPO

French medical diagnostics outfit Labco is selling out to U.K. private equity firm Cinven for €1.2 billion ($1.3 billion), shifting gears after abandoning its previously announced IPO.

Report: The sound of affordable hearing aids likely to be heard in the near future

Online startups that upended the eyeglass industry and drove prices lower are expected to do the same for hearing aids, which haven't traditionally been a cheap option for the hearing impaired.

Freedom Meditech, maker of diabetes eye scanner, raises $4.8M in Series C round

Freedom Meditech, a San Diego-based medical technology company focused on diabetes, said it raised $4.8 million in a round of Series C financing.

WSJ: J&J faces FBI probe over power morcellator devices

Johnson & Johnson is facing more backlash over power morcellator devices used in minimally invasive gynecological procedures, as the FBI investigates how much the company knew about the products' risks before pulling them from the market last year.

Hospitals demand better patient monitoring, stimulating med tech innovation

Hospitals are scrambling to monitor patients regularly, even those on the general medical and surgical floors.

NSF backs personalized, virtual heart model and robot-cell hybrids as part of $250M quest

The National Science Foundation (NSF) has given a total of $8.75 million in 5-year grants to two sets of academic researchers working on medical and cyber-physical systems. One is pursuing a computational model to test how a specific patient's heart will interact with a particular cardiac medical device, while the other is working to combine nano-scale robotics with synthetically designed biological organisms.

Former high-ranking healthcare official arrested in China on bribery charges

The former leader of the federal agency in charge of managing medical device (and drug) clinical trials in China has been arrested for bribery, in the latest sign that President Xi Jinping's crackdown on corruption within the healthcare sector remains alive and well.

Scientists push back against cancer hereditary genetic tests in NEJM paper

The U.S. Supreme Court ruling invalidating two of Myriad Genetics' patents for BRCA1 and BRCA2 genes opened the door for competition from companies such as Invitae and Illumina. But now, companies producing the tests are facing pushback from international scientists saying the tools should not be offered to patients until more is known about them.

NeuroMetrix raises $15M--more than its market cap--to sell OTC wearable pain device Quell

Micro-cap NeuroMetrix has managed to raise $14.7 million via a complex, warrant-laden deal, despite the fact that its market cap continues to hover right around $10 million. The company is betting that it has a winner in its Quell over-the-counter pain relief device that FDA cleared in July 2014.

UPDATED: CareFusion's Avea ventilator recalled as potentially deadly

CareFusion's Avea ventilator was just hit with a Class 1 recall from the FDA, meaning the agency believes there is a reasonable probability that exposure to or use of the 15,905 violative devices "will cause serious adverse health consequences or death."