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. Medtech sits on the sidelines as ACA repeal looms
Some major medical device industry lobbying groups are staying mum for now about the expected repeal of the U.S. Affordable Care Act—even though an extensive overhaul of the national healthcare system would have a serious impact on medtech.
With so much unpredictability around how the incoming Trump administration and the new Republican Congress will replace the ACA, the industry’s representatives have been taking more of a wait and see approach. Read more
4. Baxter to pay $18m to settle moldy IV plant case
Baxter agreed to pay $18 million to settle criminal and civil cases stemming from a North Carolina sterile intravenous solution plant where mold was found in air filters.
The agreement includes penalties and forfeitures of some $16 million and another $2.2 million to settle a civil qui tam lawsuit with the U.S. Justice Dept. Whistleblower Christopher Wall, who filed the False Claims suit, is due to receive about $432,000 from the case, according to the Justice Dept. Read more
3. Nordisk takes a hit from Trump, lawsuit
Novo Nordisk shares fell more than 5% yesterday, following comments from the President-elect regarding drug prices and a lawsuit alleging that the Danish diabetes giant made misleading earning forecasts.
The securities class action lawsuit against Nordisk also named Eli Lilly, Sanofi and Merck, claiming that Nordisk’s reported earnings and forecasts were inflated through price fixing for the company’s insulin drugs. Read more
2. Dexcom surges on Medicare nod for continuous glucose monitors
DexCom said yesterday that the Centers for Medicare & Medicaid classified therapeutic continuous glucose monitors as durable medical equipment under Medicare Part B. The company’s Dexcom G5 Mobile is the only CGM system that falls under this classification, according to San Diego, Calif.-based DexCom, since patients can make treatment decisions using the device.
DXCM shares were down -2.1% at closing yesterday, but came back 12.3% this morning in pre-market trading. Read more
1. Johnson & Johnson recalls DePuy Synthes knee component
Johnson & Johnson is recalling its DePuy Synthes radial head prosthesis because of the risk of loosening in the component that anchors the implant in the leg’s radius bone.
The entire prosthesis is designed for primary and revision replacement of the radial head, but only the radial stem surgeons insert into the radius is involved in the loosening issue, according to a letter the J&J unit sent to physicians Dec. 30, 2016. Read more