Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 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.
Get this in your inbox everyday by subscribing to our newsletters.
Abbott said today that its St. Jude Medical subsidiary won CE Mark approval in the European Union for the ConfirmRx insertable cardiac monitor, touting as the world’s 1st smartphone-compatible ICM.
The continuous heart monitor is designed to work with St. Jude’s myMerlin mobile app to allow physicians to remotely follow patients and diagnose arrhythmias. Abbott said it’s on the market in 10 “select” countries in Europe, with a full release slated for the 2nd quarter. The FDA is also reviewing the device, the Chicago-area healthcare giant said. Read more
Visunex Medical Systems said last week that it raised a $20 million Series B round for its PanoCam line of neonatal eye imaging systems.
Fremont, Calif.-based Visunex said the PanoCam line includes the LT and Pro wireless systems and a 3rd system set to debut in June. Read more
Medrobotics said today that it won 510(k) clearance from the FDA for a colorectal procedure indication for its Flex robot-assisted surgery platform.
The Raynham, Mass.-based company won expanded CE Mark approval in the European Union last October for Flex for performing colorectal procedures. The system won 510(k) clearance from the FDA for transoral procedures in July 2015 (that indication won CE Mark approval back in March 2014). Medrobotics bills itself as the 1st robotics firm to offer minimally invasive and steerable robotic products for colorectal applications. Read more
The possible enactment of a Trumpcare plan, following last week’s U.S. House of Representatives vote to approve the American Healthcare Act, would likely have a minimal negative effect on the medical device industry – and repealing Obamacare might even provide a bit of tailwind.
The House voted May 4 to repeal major parts of the Affordable Care Act and replace it with a Republican plan, on a 217-213 vote that saw 20 Republicans break ranks. The bill now is on hold while the Senate comes up with its own bill; the 2 would then have to be reconciled to clear both chambers before being sent to the White House. Read more
A federal jury in Texas last week cleared Zimmer Biomet in a product liability lawsuit brought over its recalled Trilogy hip implant.
Plaintiff Martha Hardy sued Zimmer Biomet in March 2016, 4 years after a total right hip arthroplasty using the company’s Trilogy acetabular shell and Trilogy acetabular spike but before the devices were pulled from the market in June 2012 ( a full recall went into effect in September of that year, after the FDA sent Zimmer Biomet a warning letter). Read more