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.
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5. Senate bill would streamline FDA’s medical device reviews
A bipartisan duo in the U.S. Senate introduced a bill last week that aims to streamline the way the FDA reviews medical devices.
Sens. Amy Klobuchar (D-Minn.) and Pat Roberts (R-Kan.) introduced S.2737, or “A bill to improve medical device innovation,” to the Upper Chamber’s Health, Education, Labor & Pensions committee March 17. Read more
4. Medinol launches trial for NIRxcell stent
Medinol said it enrolled the 1st U.S. patient in a post-market study of its bare-metal NIRxcell stent, which has been on the U.S. market since January 2015.
Tel Aviv-based Medinol said the NIRxcell stent is a 5th-generation stent using its WiZeCell design and the Flexx2 spring-tip delivery catheter. The device 1st won pre-market approval from the FDA in December 2013. Read more
3. Cardiovascular Systems to settle lawsuit for $8m
Cardiovascular Systems said that it agreed to an $8 million settlement with the plaintiff in a False Claims Act lawsuit based on allegations from a former sales rep that the company ran kickbacks and an off-label marketing scheme to boost sales of its orbital artherectomy devices.
The deal calls for St. Paul, Minn.-based Cardiovascular Systems to pay the $8 million over 3 years, not including plaintiff Travis Thams’s legal costs. The company said the final terms of the deal must still be ironed out. Read more
2. Johnson & Johnson looks to settle morcellator lawsuits
Johnson & Johnson is reportedly looking to settle 100s of product liability and wrongful death lawsuits brought over its now-recalled laparoscopic power morcellators used during surgeries to remove ostensibly benign uterine tumors.
The morcellators, which use a cutting tip to shred and remove uterine tissue, have been implicated in the spread of a lethal cancer that can masquerade undetected as benign fibroids. Read more
1. Judge: Doc can’t drag Globus into patent spat with Medtronic
A doctor suing Medtronic for allegedly infringing his patents covering spinal deformity repair devices can’t drag Globus Medical into the dispute, a federal judge in Pennsylvania ruled.
Dr. Mark Barry sued Medtronic in February 2014 in a Texas federal court, alleging infringement of a trio of patents covering a “System and method for aligning vertebrae in the amelioration of aberrant spinal column deviation conditions” (the 3rd patent was later dropped from the suit; Barry licenses the patents to Zimmer Biomet). Medtronic asked the U.S. Patent & Trademark Office for an inter partes review of the patents a year later, but the patent office’s Patent Trial & Appeals Board declined to grant the review, according to court documents. Read more
The post MassDevice.com +5 | The top 5 medtech stories for March 21, 2016 appeared first on MassDevice.
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