Medtronic (NYSE:MDT) said today that the FDA approved its Resolute Onyx drug-eluting stent. The Fridley, Minn.-based company touted its device as the 1st stent formed by a sinusoidal wave of cobalt alloy wire. The company incorporated a radiopaque inner core within the wire to boost visibility, according to Medtronic. The stent also features thin struts and a polymer […]
Food & Drug Administration (FDA)
Medtech stories we missed this week: April 28, 2017
From FDA and Health Canada approvals to joint ventures, here are medtech stories we missed this week but thought were still worth mentioning. 1. FDA clears Joimax Endovapor 2 Joimax announced in an April 26 press release that it has received FDA 510(k) clearance to market its Endovapor 2 Multi-Radio Frequency System. The device generates […]
Nordisk wins label update for weight loss drug-device combo
Novo Nordisk (NYSE:NVO) said today that the FDA approved an updated label for its Saxenda liraglutide weight loss medicine. The therapy’s new label will include data showing that half of patients who received Saxenda and lost at least 5% of their weight after 56 weeks maintained their weight loss for 3 years. The update is based […]
Alnylam, The Medicines Co., detail Phase III trial for RNA-based heart drug
The Medicines Co. (NSDQ:MDCO) and Alnylam Pharmaceuticals (NSDQ:ALNY) said today that they’ve reached a deal with the FDA over a Phase III trial for the companies’ RNA-based cholesterol-lowering drug, inclisiran. If approved, it would be the 1st RNA-interference therapy on the market. The drug is a part of a new group of drugs called PCSK9 […]
Sanofi, Regeneron win FDA nod for once-monthly cholesterol injection
Sanofi (NYSE:SNY) and Regeneron (NSDQ:REGN) said today that the FDA approved the companies’ new supplemental Biologics License Application for a once-monthly, 300 milligram dose of Praluent as a treatment for adults with high low-density lipoprotein cholesterol. The 300 milligram dose is administered using 2 pre-filled pens that each deliver 150 milligrams at an injection site. The […]
How medtech companies can benefit from agile marketing
Getting a medical device to market can be tough. It has to go through several hoops at the FDA, including the 5-step premarket requirements that include: classifying the device; choosing the correct premarket submission; preparing appropriate information for premarket FDA submission; sending a premarket submission to the FDA and communicating with FDA staff during review; and […]
Improving the safety of imported foods through partnerships
By: Susan Mayne, Ph.D., Camille Brewer, M.S., R.D., and Donald Prater, D.V.M. At FDA, we recognize that the partnerships we build with other nations are key to our success in giving American consumers confidence in the safety of the foods they choose to serve their families. In passing the FDA Food Safety Modernization Act (FSMA), […]
Medtech stories we missed this week: April 21, 2017
From new and renewed partnerships to FDA approvals, here are medtech stories we missed this week but thought were still worth mentioning. 1. Life Spine receives FDA clearance for cervical spacer system Life Spine announced in an April 19 press release that it has received FDA 510(k) clearance for its Plateau-C Ti Cervical Spacer System. The system uses […]
23andMe is back: FDA allows marketing of genetic health risk tests
FDA this month allowed genetic testing company 23andMe to market genetic health risk tests for 10 diseases and conditions including Parkinson’s disease and late-onset Alzheimer’s disease. The de novo premarket review authorization, announced April 6, also included celiac disease, which results in the inability to digest gluten; alpha-1 antitrypsin deficiency, which raises the risk of […]
America’s Got Talent – regulatory science style
By: Stephen Ostroff, M.D. Veni Vidi Vici. It translates into English as “I came, I saw, I conquered.” It also happens to be the name chosen by one of the winners of the recently held America’s Got Regulatory Science Talent Competition. FDA recognizes that young scientists are our future. Now in its fifth year, America’s Got Regulatory […]
