FDA undoubtedly provided some good news to the medical device industry last month when it proposed exempting hundreds of moderate-risk devices from 510(k) requirements. But don’t break out the champagne just yet if you happen to be developing a device that appears to be on the list. Even when the agency says a particular generic […]
510(k)
Additive Orthopaedics wins FDA nod for 3D printed Locking Lattice Plating System
Early-stage orthopedics company Additive Orthopaedics said today it won FDA 510(k) clearance for its 3D printed Locking Lattice Plating System. The Little Silver, N.J.-based company said the Locking Lattice system is designed for the stabilization and fusion of fractures, osteotomies and arthrodesis of small bones. “We are excited to be one of the first companies to leverage […]
Advanced Cooling Therapy wins FDA 510(k) for Esophageal Cooling Device
Advanced Cooling Therapy said today it won FDA 510(k) clearance for its Esophageal Cooling Device with an integrated Altrix precision temperature management system from Stryker (NYSE:SYK). The Chicago-based company said the triple lumen system is designed to be inserted into the esophagus, with 2 lumens attached to existing temperature modulation equipment while a 3rd lumen simultaneously […]
Ventec Life Systems wins FDA nod for VOCSN portable life support device
Respiratory care device developer Ventec Life Systems said today it won FDA 510(k) clearance for its VOCSN portable life support device. The VOCSN device provides 5 different respiratory therapies, including ventilation, oxygen, cough, suction and nebulization. The Bothell, Wash.-based company claims it is the only device cleared by the FDA which provides all 5 respiratory […]
FDA clears Bausch & Lomb’s Stellaris Elite cataract system
Valeant Pharmaceuticals (NYSE:VRX, TSE:VRX) subsidiary Bausch & Lomb said today it won FDA 510(k) clearance for its Stellaris Elite vision enhancement system. The system is a next-gen phacoemulsification cataract platform designed for cataract lens removal, and offers improved customization and precise aspiration control with predictive infusion management, Bausch & Lomb said. “We are pleased to continue […]
AirXpanders wins FDA nod for next-gen AeroForm tissue expander components
AirXpanders (ASX:AXP) saw shares rise today after it won FDA 510(k) clearance for an enhanced film material used to contain carbon dioxide in its AeroForm Tissue Expander system The Palo Alto, Calif.-based company’s AeroForm tissue expander is designed for use in post-mastectomy breast reconstructions to expand and stretch the skin and underlying muscle prior to a […]
FDA clears Bodycad’s personalized unicompartmental knee system
Canadian orthopedic developer Bodycad said today it won FDA 510(k) clearance for its Bodycad unicompartmental knee system and launched the device in the US. The company said that the clearance makes it the 1st Canadian company to win FDA clearance for a joint reconstruction implant system. “The personalized restoration is created only after proper acquisition of […]
BioStable Science & Eng wins FDA nod for Haart 300 aortic annuloplasty device
Cardiovascular device developer BioStable Science & Engineering said yesterday it won FDA 510(k) clearance for its Haart 300 aortic annuloplasty device. The Austin, Texas-based company touted the Haart 300 as the 1st commercially available internal annuloplasty device designed for aortic valve repair, expected to be available to select US heart centers this summer. “We are very grateful for […]
FDA clears Toshiba Medical’s Aplio i900 cardiovascular ultrasound
Canon‘s (NYSE:CAJ) Toshiba Medical subsidiary said today it won FDA 510(k) clearance for its Aplio i900 cardiovascular ultrasound system and launched the device in the US. The Tustin, Calif.-based medical subsidiary said the Aplio i900 is designed to allow clinicians to assess myocardial function or quantify complex valvular lesions with a greater depth and detail than previous […]
7 medtech stories we missed this week: March 17, 2017
The FDA awarded 510(k) clearance to a couple of medtech companies this week while others received tax breaks and incentives, including a local tax break for a $154 million Stryker R&D facility planned in Michigan. Here are 7 medtech stories we missed this week but thought were worth mentioning. 1. FirstRay wins FDA 510(k) clearance […]
DJO Global wins FDA 510(k) for Exprt revision hip portfolio
DJO Global said today it won FDA 510(k) clearance for its Exprt revision hip portfolio. The newly cleared Exprt devices feature anatomically inspired designs with a focus on efficiency and strength, according to the San Diego, Calif.-based company. DJO Global also touted the system as 40-70% of the price of comparable systems. “Having a thoughtful approach […]