Longer, more extensive studies and a focus on subjective quality of life outcomes were among the top agreed upon recommendations for future trials studying transvaginal mesh implants used for treating pelvic organ prolapse, according to a MedTech Dive report covering the recently held FDA transvaginal mesh advisory panel. While the panelists didn’t vote on any […]
FDA goes after California stem cell doc for unapproved breast implant device
The FDA this week sent a warning letter to a Beverly Hills, Calif.-based surgeon for their marketing of an unapproved implantable device, dubbed the Pocket Protector, which the surgeon claims can prevent and treat capsular contracture, or scar tissue tightening, during breast implant procedures. In its letter, the federal watchdog also accuses the surgeon, Dr. […]
Tandem wins interoperable claim for insulin pump from FDA
The FDA announced this week that it established Tandem Diabetes Care‘s (NSDQ:TNDM) t:slim X2 insulin pump as the first in a new category of devices called ‘Alternate Controller Enabled Infusion Pumps’ or ACE pumps. The newly-approved indication for Tandem’s t:slim X2 pump clears the device to communicate with compatible products, including insulin dosing software and continuous glucose […]
Corindus asks FDA for expanded neurosurgery indication for CorPath GRX
Corindus Vascular Robotics (OTC:CVRS) said today that it submitted an application seeking FDA premarket clearance to use its CorPath GRX robotic surgical platform in neurovascular interventions. The Waltham, Mass.-based company has already received FDA clearance for percutaneous coronary interventions, which it won in 2016, and for peripheral vascular interventions, which it won last year. “The ability to […]
FDA green-lights early feasibility trial for Foldax’s Tria biopolymer heart valve
Early stage cardiovascular device company Foldax said today it won FDA investigational device exemption approval to launch an early feasibility study of its Tria surgical aortic heart valve. The valve uses a proprietary biopolymer material, dubbed LifePolymer, as well as a proprietary design, the Salt Lake City-based company said. Foldax touted that the Tria heart […]
Ocugen wins orphan drug status for ocular gene therapy
The FDA has given Ocugen orphan drug status for a gene therapy designed to treat NR2E3 mutation-associated retinal degenerative disease. The Malvern, Penn.-based company’s OCU400 product includes an adeno-associated virum serotype 5 capsid that contains the gene for human nuclear hormone receptor NR2E3. Get the full story at our sister site, Drug Delivery Business News.
FDA committee backs J&J’s nasal spray for depression
An FDA advisory committee has voted to support Johnson & Johnson‘s (NYSE:JNJ) Spravato esketamine nasal spray product as a therapy for adults living with treatment-resistant depression. J&J’s Janssen touted that if the U.S. regulatory agency decides to approve Spravato, it would be the first medicine in 30 years to sport a new mechanism of action to treat major […]
Bausch + Lomb wins FDA 510(k) for contact lens coating
Bausch + Lomb said today that it won FDA 510(k) clearance for the use of Tangible Hydra-PEG contact lens coating on new devices, now cleared for use with lenses made from its Boston gas permeable materials. The new clearance will allow the Bridgewater, N.J.-based company to use the coating on its Boston XO, Boston XO2, […]
Becton Dickinson wins FDA 510(k) for Wavelinq 4F endoAVF system
Becton Dickinson (NYSE:BDX) said today that it won FDA 510(k) clearance for its WavelinQ 4 French endovascular arteriovenous fistula creation system. The Franklin Lakes, N.J.-based company said that the newly cleared WavelinQ 4F endoAVF system features improved technology that allows for the creation of an AVF in either the ulnar artery and ulnar vein or the radial […]
161m medical device units recalled in Q4 2018
The number of medical device units recalled in the fourth quarter of 2018 skyrocketed by 449% to 161 million from the same quarter a year ago, according to a report by Stericycle Expert Solutions. Those figures made it the second highest quarter for medtech units recalled since at least 2004. Medical device recalls fell by 1%, lower […]
Intrinsic Therapeutics wins PMA for Barricaid spinal implant despite safety concerns
Intrinsic Therapeutics has won FDA premarket approval for its Barricaid anular closure device intended for preventing reherniation, according to a recent FDA posting. The approval comes despite the fact that the prosthesis, which is designed for partial anulus replacement in patients with herniated discs, received a 5-8 advisory panel against recommending approval in December 2017. […]
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