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 […]
Food & Drug Administration (FDA)
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 […]
Medtech stories we missed this week: April 14, 2017
From FDA approvals to business expansion plans, here are medtech stories we missed this week but thought were still worth mentioning. 1. BioTelemetry launches offer to acquire LifeWatch BioTelemetry and LifeWatch announced in an April 9 press release that the 2 companies have entered a transaction agreement that states BioTelemetry will launch a tender offer to acquire all […]
Cytori wins FDA nod for cell therapy pilot trial
Cytori Therapeutics (NSDQ:CYTX) said today that the FDA approved an Investigational Device Exemption for a pilot trial of the company’s cell therapy in patients with thermal burn injury. The Relief trial is a part of Cytori’s ongoing R&D efforts under its contract with the U.S. Dept. of Health & Human Services’ Biomedical Advanced Research and […]
SteadyMed studies accuracy and precision of PatchPump infusion system for Trevyent
SteadyMed (NSDQ:STDY) said yesterday that it finished a clinical study for its lead drug candidate, Trevyent. The pulmonary arterial hypertension treatment is a combination of treprostinil and the PatchPump prefilled, disposable infusion system. The San Ramon, Calif.-based company said it is on track to submit a New Drug Application for Trevyent in the 2nd quarter […]
United delays Remosynch launch until 2018
Shares in United Therapeutics (NSDQ:UTHR) fell -7% this morning to $126.17 apiece after the company said that the U.S. commercial launch of Remosynch, Medtronic‘s (NYSE:MDT) implantable infusion pump for Remodulin, will be delayed until 2018. “United Therapeutics’ commitment to bringing better therapies to patients transcends temporary delays or setbacks,” United chairman & CEO Martine Rothblatt said in […]
EpiPen manufacturer expands recall to U.S.
Mylan (NSDQ:MYL) said last week that its manufacturing partner, Meridian Medical Technologies, expanded an EpiPen recall to include the U.S. and other markets. The move comes 1 week after Mylan recalled 81,000 EpiPen devices in countries outside the U.S. following 2 reports that the allergy auto-injector failed to work in emergency situations. “While the number of reported […]
Medtech stories we missed this week: March 31, 2017
This week we saw a few FDA 510(k) clearances and one of the 1st uses of a next-generation surgical robot in Asia. Here are medtech stories we missed this week but thought were still worth mentioning: 1. Corindus touts first Asian use of next-generation robot Corindus Vascular Robotics announced in a March 31 press release that robot-assisted […]
RenovoRx wins label expansion for RenovoCath device
RenovoRx said yesterday that it won label expansion for the RenovoCath dual-balloon infusion catheter to include the delivery of chemotherapeutics. The device isolates segments of the peripheral vasculature, allowing doctors to deliver therapeutics in a more targeted fashion, according to the Los Altos, Calif.-based company. “This additional FDA indication marks yet another milestone for RenovoRx as […]
FDA in India – championing a culture of quality
By: Mary Lou Valdez One of FDA’s most strategic outposts is in India, the seventh largest supplier of food and second largest supplier of pharmaceuticals and biologics to the United States. The agency’s office, located in the capital, New Delhi, works to ensure the safety and security of food and the safety and efficacy of […]
