MassDevice.com +3 | The top 3 medtech stories for September 23, 2015

Say hello to MassDevice +3, a bite-sized view of the top three medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.

 

3. FDA slams Sironis for running unapproved trial

The FDA slammed Sironis for running an unapproved clinical trial of its LIR closed-loop fluid administration system, saying the Newport Beach, Calif.-based company never sought the proper approvals from the federal safety bureau.

In a warning letter dated March 15 and released by the FDA this week, the agency flagged Sironis for serious violations of clinical trial regulations, saying the company failed to ask for or won an investigational device exemption for the trial. Read more

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2. J&J’s Ethicon appeals $3m loss in pelvic mesh case

Johnson & Johnson subsidiary Ethicon appealed a $3.3 million loss in product liability lawsuit brought over its TVT-O pelvic mesh.

Last month a federal judge shot down Ethicon’s bid to overturn the verdict and denied the company’s move for a new trial. Read more

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1. How Valencia Technologies got its anti-hypertension implant to trial for less than $11m

Jeff Greiner would be the 1st to tell you that developing a neurostimulation implant is an expensive process. It took $100 million for Advanced Bionics to develop a cochlear implant, Greiner told MassDevice.com, and another $50 million for its neurostim device. CVRx has raised more than $250 million for its neurostim implant for treating cardiovascular conditions, he noted.

That’s why it’s remarkable that Valencia Technologies, which is developing a coin-sized implant designed to treat hypertension, spent less than $10.5 million designing the device and getting it through a double-blind clinical trial. Read more

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