Say hello to MassDevice +3, a bite-sized view of the top three med-tech 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. Al Gore talks sea change in medicine | MassDevice.com On Call
MASSDEVICE ON CALL — Former Vice President Al Gore isn’t just about climate change anymore. In a video interview with Medscape editor-in-chief Dr. Eric Topol, the politician-turned-activist talked about healthcare evolutions he saw while in office and what he sees for the future.
Gore said that he’s been surprised by the burgeoning advancements in life sciences that had been taking place while he was engrossed in climate change research, but his tenure in the House and Senate were rich with talk of breakthroughs in genetic engineering. Read more
2. Wearable computing at BIDMC
Over the past few months, Beth Israel Deaconess has been exploring the use of wearable computing.
In the Emergency Department we’ve been evaluating an early unit of Google Glass, a high tech pair of glasses that includes a video camera, video screen, speaker, microphone, touch pad, and motion sensor. Read more
1. FDA says NeoMedix is selling glaucoma device without approval
FDA officials chided medical device maker NeoMedix Corp. for violations of U.S. law, saying that the company is selling its Trabectome device without proper agency approval.
NeoMedix won FDA 510(k) approval in April 2006 for the Trabectome device, with indication for “use with compatible electrosurgical instruments in low power microsurgical applications for the removal, destruction and coagulation of tissue. The decision summary doesn’t appear to specify procedures in which the device may be used. The FDA warned that the company’s marketing of the device for use during glaucoma surgery fell outside of the parameters of the 510(k) clearance. Read more