More than a month before it was due to make a decision, the FDA yesterday approved a CAR-T cell therapy from Kite Pharma (NSDQ:KITE) – the first of its kind for adults. The therapy, which is made from a patient’s own cells, is designed to treat adults with non-Hodgkin lymphoma who have failed at least two other […]
An FDA advisory committee has voted favorably to approve Novo Nordisk‘s (NYSE:NVO) once-weekly semaglutide Type II diabetes drug. Shares in the insulin maker were up 2% in after-hours activity today, trading at $50.13 apiece. Get the full story at our sister site, Drug Delivery Business News.
The FDA this week released warning letters it sent to 2 medical device manufacturers in response to letters related to previous inspections at craniofacial implant maker Kelyniam Global and dialysate maker Diasol. The federal watchdog said it was responding to a letter it received from Director Dr. Mark Smith at Kelyniam in June after having […]
DarioHealth (NSDQ:DRIO) said today that it won CE Mark approval for the version of its Dario blood glucose monitoring system that fits with the Lightning connector on Apple’s iPhone 7 and iPhone 8 smart phones. With this regulatory win, DarioHealth’s smart glucose meter can be used with a 3.5 mm headphone jack or Lightning connector, the […]
OptiScan Biomedical said today that its OptiScanner 5000 glucose monitoring system won 510(k) clearance. The device is the first of its kind, providing physicians with trending and tracking information to manage their patients’ blood glucose levels in surgical intensive care units. Get the full story at our sister site, Drug Delivery Business News.
Viveve (NSDQ:VIVE) said today it won approval from Mexico’s regulatory authority, COFEPRIS, to market its Viveve system in Mexico with indications for treating vaginal introitus, after vaginal childbirth and to improve sexual function. The Englewood, Colo.-based company’s Viveve System is designed as a non-surgical treatment for post-partum laxity of the vaginal introitus. The new regulatory clearance brings the […]
Anika Therapeutics (NSDQ:ANIK) said yesterday that regulatory authorities in Australia approved the company’s single injection viscosupplement, Monovisc, for the treatment of pain associated with osteoarthritis of the synovial joints. This latest regulatory win means that Monovisc is commercially available in more than twenty countries, including the U.S. and Canada. The Bedford, Mass.-based company said it plans […]
Second Sight Medical (NSDQ:EYES) said today it won approval from Germany’s BfArM regulatory body to initiate a 10-patient study exploring the use of its Argus II retinal prosthesis system in better sighted retinitis pigmentosa patients and individuals with tunnel vision. The Argus II induces visual perception in patients with retinitis pigmentosa by stimulating of the retina’s […]
Medizone International (OTC:MZEI) said today that it won CE Mark approval in the European Union for its AsepticSure disinfection system. The AsepticSure system is designed to be turned on from outside the room to be disinfected, enabling the machine to safely fill the room with a disinfecting gas formula. The device later clears the atmosphere […]
Stryker (NYSE:SYK) said today it won FDA 510(k) clearance for its cementless Mako total knee system with Triathlon Tritanium. The Kalamazoo, Mich.-based company touted the Triathlon Titanium as combining kinematics from its Triathlon knee with highly porous biologic fixation technology. The system features the company’s Tritanium tibial baseplate and metal-backed patella components as well, the company said. […]
TransEnterix (NYSE:TRXC) said last week that it won 510(k) clearance from the FDA for its Senhance robot-assisted surgery platform. TransEnterix, which acquired Senhance for $100 million in September 2015, finalized its clerarance bid last month after applying in April. Get the full story from our sister site, The Robot Report.