Devices & Diagnostics

Senate bill proposes tracking medical implants post-approval (Morning Read)

Current medical news from today, including a new bipartisan bill in the Senate proposed increased monitoring of implantable medical products post-approval, legislators renew and amend SBIR program to include venture-backed companies, and unintended side effects of mobile health.

Current medical news and unique business news for anyone who cares about healthcare.

Should device makers have to follow-up on implants post-approval? A bipartisan bill was introduced in the Senate yesterday that would require implantable medical device manufacturers to do a better job of tracking certain products that don’t require human testing for approval after they’ve been cleared. The New York Times reports that senators proposed the tighter measures in response to thousands of artificial implants that were approved through the 510(k) process and are now failing.

Amendments to the renewed SBIR program. A new agreement negotiated between the House and Senate is opening the doors for companies that are majority-owned by venture capital firms to have access to Small Business Innovation Research grants as the program was amended and renewed for six more years. The NIH and National Science Foundation can now designate a fourth of their SBIR dollars to VC-backed biotechs. The Biotechnology Industry Association and VC firms lobbied for this move.

Distracted doctoring from devices. Are electronic medical records and mHealth becoming dangerous? We’ve heard about how mobile health and electronic patient data are revolutionizing how care is delivered, saving lives, etc. But some providers say an unintended side effect of technology could in fact be putting lives in danger. More than half of technicians running bypass machines admitted in a recent survey they’d texted during a procedure, and a growing number of doctors are talking about “distracted doctoring” due to mobile devices.

Thanks, Obamacare. A fun tribute to Obamacare. Some creative Obama supporters took the game of Life and turned it into a tribute to healthcare reform with the Thanks, Obamacare game.

It’s not money causing drug shortages, GAO says. When it comes to recent drug shortages, the Government Accountability Office points the finger at manufacturing problems and shutdowns, not the economy. In a report released today, the GAO says a lack of raw materials, communication errors and other unspecified manufacturing errors are responsible for a majority of shortages. A hearing on the topic is scheduled for today.