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.
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
