The California Life Sciences Assn. and PricewaterhouseCoopers released their annual Life Sciences Industry Report, highlighting continued growth and a robust pipeline of medical devices and other therapies in California this year. California, which is ranked 1st for medical device and biopharmaceutical employment in the country, saw 7% employment growth in the sector between 2011 and 2015. […]
Food & Drug Administration (FDA)
Xtant Medical raises $4m, wins FDA nod for Irix-C cervical cage
Xtant Medical (NYSE:XTNT) said today it raised $3.8 million from a recent offering, and won FDA clearance for its Irix-C cervical cage. Subscriptions to the offering, offered at 75¢ per unit, ended yesterday. The Belgrade, Mont.-based company expects the offering to close completely on November 17, according to a press release. Xtant priced the offering earlier […]
FDA clears Channel Medical Cerene endometrial ablation trial
Channel Medsystems said today it won FDA investigational device exemption trial approval to run a pivotal trial of its Cerene cryotherapy device designed for endometrial ablation. The multicenter pivotal trial aims to examine the safety and effectiveness of the Emeryville, Calif.-based company’s Cerene device in endometrial ablation procedures for women with heavy menstrual bleeding who […]
FDA clears CapsoVision’s CapsoCam Plus for small bowel endoscopy
Miniature medical device developer CapsoVision said today it won FDA 510(k) clearance for its novel CapsoCam Plus small bowel capsule endoscope system. The Saratoga, Calif.-based company’s system is designed to provide a 360 degree panoramic lateral image of the small bowel for the detection of small bowel abnormalities. The full system consists of a capsule […]
St. Jude wins MRI nod for Proclaim Elite spinal cord stim
St. Jude Medical (NYSE:STJ) said today it won FDA approval for magnetic resonance imaging conditional labeling for its Proclaim Elite spinal cord stimulation system Patients using the company’s Proclaim Elite SCS are now cleared or full-body MRI diagnostics scans, the Little Canada, Minn.-based company said. “This MR Conditional labeling applies to both new patients and those […]
OCUL’s Dextenza meets endpoints in pivotal study
Ocular Therapeutix (NSDQ:OCUL) said today that its post-surgical ocular pain reliever, Dextenza, met both primary endpoints in a pivotal trial for the treatment of post-surgical ocular inflammation and pain. The product is a bioresorbable intracanalicular insert, designed for drug release to the ocular surface for up to 30 days. The randomized, double-masked study enrolled 438 patients who were […]
Final FDA rules clarify adverse event reporting for contract manufacturers
The FDA last week issued final guidance for medical device companies on the requirements for reporting adverse events that walked back much of the burden for contract manufacturers. The federal safety watchdog’s draft guidance for “Medical Device Reporting for Manufacturers,” issued in July 2013, put both the contract manufacturer and its customer on the hook for reporting adverse […]
FDA approves Medtronic’s Claria MRI quad CRT-D
Medtronic (NYSE:MDT) said today that it won pre-market approval from the FDA for its Claria MRI quad cardiac resynchronization therapy defibrillator for magnetic resonance imaging scans at both 1.5 and 3 Tesla. “The Claria MRI CRT-D is our latest innovation to help improve patients’ response to CRT, establishing a new level of personalized care,” heart […]
Ocular Therapeutix plans FDA re-submission for Dextenza by end of year, earnings
Shares in Ocular Therapeutix (NSDQ:OCUL) surged this morning after the biopharmaceutical company met expectations on Wall Street with its 3rd-quarter results and announced it will re-submit its new drug application to the FDA for Dextenza, its post-surgical ocular pain reliever, by the end of the year. In July, the FDA denied approval for Ocular’s hydrogel plug designed […]
FDA warns Valeant on SPAG-2 nebulizer, OraPharma OnSet mixing pen
The FDA this month warned Valeant Pharmaceuticals (NYSE:VRX) on violations found during inspections of its Rochester, N.Y., plant last summer. The federal safety watchdog, in a Nov. 3 warning letter posted online today, wrote that inspections from Aug. 23 through Sept. 1 turned up problems with its small-particle aerosol generator, the SPAG-2 device, and a high-precision compound and dispensing […]
Propeller wins FDA nod for connected GSK Ellipta inhaler
Propeller Health said today that it won 510(k) clearance from the FDA to market its Propeller platform with GlaxoSmithKline‘s (NYSE:GSK) Ellipta inhaler. A sensor for the dry powder inhaler was built as a part of a 1 year-long development and R&D collaboration between Propeller and GSK. This marks the 8th clearance for Propeller’s connected inhaler […]