VisionCare, Inc. said this week that the FDA approved its investigational device exemption for a new clinical trial in the U.S. evaluating its telescope implant in patients with end-stage macular degeneration. The Saratoga, Calif.-based company’s implantable miniature telescope, which was developed by Israeli inventor Dr. Isaac Lipshitz, is contraindicated for patients with previous intraocular or […]
Judge blocks dialysis aid rule
(Reuters) – A U.S. judge on Thursday put on hold a new federal rule that dialysis providers have said would prevent dialysis patients from using charitable assistance to buy private health insurance. U.S. District Judge Amos Mazzant in Sherman, Texas stopped the rule from taking effect Friday as planned. The decision is a victory for […]
Sunshine Heart tumbles on 1-30 reverse split
Shares in Sunshine Heart (NSDQ:SSH) fell slightly today after it announced a 1-for-30 reverse split of its common stock. The company’s common stock will continue to trade under the same symbol on the NASDAQ market. SSH shares were trading at $8.40 apiece in afternoon activity, down -5%. At the company’s stockholders meeting on January 9, […]
Fujifilm pulls older duodenoscopes after superbug outbreaks
Fujifilm Holdings (TSE:4901) said today that it will pull its legacy 250/450 duodenoscope models from clinical use and replace those devices with the ED-530XT model at no cost to its customers. The company said in a letter to its customers that the decision is not directly related to any safety concerns and that it has not received any recent […]
OtoNexus raises $8m for middle-ear infection tech
OtoNexus Medical Technologies raised $7.9 million to fund development of its ultrasound device used to diagnose middle-ear infections in children and determine if antibiotics are needed for treatment. The Seattle-based company sold nearly $8 million in equity of its $9.2 million offering. CEO Caitlin Cameron filed a Form D with the Securities & Exchange Commission, […]
HHS nominee Price to deal healthcare stocks, including ZBH
President-elect Donald Trump’s pick for secretary of Health and Human Services, Dr. Thomas Price, said yesterday that he will sell his individual stock holdings if he is confirmed as a member of the cabinet to avoid any conflicts of interest. Price is a Republican congressman from Georgia, an orthopedic surgeon and an active investor in stocks […]
Nordisk takes a hit from Trump, lawsuit
Novo Nordisk (NYSE:NVO) 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 (NYSE:LLY), Sanofi (NYSE:SNY) and Merck (NYSE:MRK), claiming that Nordisk’s reported earnings and forecasts were inflated through price fixing for the company’s […]
Dexcom surges on Medicare nod for continuous glucose monitors
DexCom (NSDQ:DXCM) 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 […]
CVS to sell cheaper, generic version of Impax’s allergy injection
CVS Health Corp. (NYSE:CVS) said today that it will start selling a generic version of Impax Laboratories‘ (NSDQ:IPXL) emergency allergy injection, Adrenaclick. The device is similar to Mylan‘s (NSDQ:MYL) EpiPen, although regulators do not consider the 2 devices to be exactly the same. The Adrenaclick has a list price of more than $400, but the generic […]
Senate reintroduces bill to repeal medical device tax
A bipartisan group of senators reintroduced the Medical Device Access and Innovation Protection Act today, which would do away entirely with the 2.3% excise tax on medical devices. The move comes as Republicans in Congress ready to repeal Obamacare. The bill, sponsored by Sens. Orrin Hatch (R-Utah) and Amy Klobuchar (D-Minn.), would amend the Internal […]
Bracco Diagnostics wins another FDA nod for Lumason microspheres
Bracco Imaging U.S. subsidiary Bracco Diagnostics said today that it won FDA approval for its Lumason microsphere contrast agent to be used in ultrasonography of the urinary tract in pediatric patients with suspected or known vesicoureteral reflux. “The approval of Lumason for voiding ultrasonography answers an unmet medical need for an effective imaging study to […]