Acutus Medical said today it won FDA 510(k) clearance for its AcQGuide steerable sheath percutaneous catheter. The AcQGuide steerable sheath is designed to provide additional maneuverability to catheters which are advanced through the sheath and into the right or left chambers of the heart, the Carlsbad, Calif.-based company said. “Acutus has seen incredible momentum over […]
510(k)
Interscope wins FDA nod for EndoRotor resection tool
Interscope said today it won FDA 510(k) clearance for its EndoRotor endoscopic resection tool designed for gastroenterology and colorectal surgery. The Worcester, Mass.-based medical device startup said that the EndoRotor is the 1st flexible microdebrider designed for use in the digestive tract to facilitate complete removal of diseased mucosa. The device performs tissue dissection, resection and […]
Teleflex wins FDA nod for Arrow AC3 Optimus IABP
Teleflex (NYSE:TFX) said today it won FDA 510(k) clearance for its Arrow AC3 Optimus intra-aortic balloon pump. The device is designed to help weakened hearts pump blood and can deliver IABP therapy to a broad range of patients, including candidates who had previously not been considered for IABP therapy, the Wayne, Penn.-based company said. “The AC3 Optimus […]
TransEnterix files FDA 510(k) application for Senhance, prices $24.9m round
TransEnterix (NYSE:TRXC) said today that it filed an application with the FDA seeking 510(k) clearance for its Senhance robot-assisted surgery platform and priced a $24.9 million funding round. The application is a huge step forward for the company, CEO Todd Pope told MassDevice.com today in a telephone interview. “The most important milestone that we’ve hit now is […]
Galatea Surgical wins FDA 510(k) for GalaForm 3D plastic surgery scaffold
Tepha Inc subsidiary Galatea Surgical said today it won FDA 510(k) clearance for its GalaForm 3D surgical scaffold device designed for use in plastic and reconstructive surgery. The Lexington, Mass.-based company claims that the GalaForm 3D scaffold is the only 3-dimensionally contoured surgical scaffold with a reinforcing rim designed to uplift the body’s shape for […]
Bausch & Lomb wins FDA 510(k) for Vitesse open-port vitrectomy system
Valeant Pharmaceuticals (NYSE:VRX, TSE:VRX) subsidiary Bausch & Lomb said today it won FDA 510(k) clearance for its Vitesse hypersonic open port vitrectomy system. The Bridgewater, N.J.-based company touted the newly cleared system as the 1st and only hypersonic 100% open port vitrectomy system, and said it will be exclusively available on the Stellaris Elite vision enhancement […]
3Shape wins expanded FDA nod for Ortho System orthodontic software suite
Orthodontic med device firm 3Shape said last Friday it won expanded FDA 510(k) clearance for its 3Shape Ortho System software for orthodontics. The expanded indications allow for the designing of dental retainers, splints, mouthguards and nightguards in addition to previously cleared custom metal bands, export models and indirect bonding transfer media, the company said. 3Shape’s […]
7 medtech stories we missed this week: April 21, 2017
From new and renewed partnerships to FDA approvals, here are 7 medtech stories we missed this week but thought were still worth mentioning. 1. Life Spine receives FDA clearance for cervical spacer system Life Spine announced in an April 19 press release that it has received FDA 510(k) clearance for its Plateau-C Ti Cervical Spacer […]
Cardiac Insight wins FDA nod for Cardea Solo wearable ECG sensor
Cardiac Insight said today it won FDA 510(k) clearance for its Cardea Solo wearable electrocardiogram sensor. The Cardea Solo device is designed to provide both physicians and patients with cardiac data and help diagnose a variety of arrhythmias including atrial fibrillation, the Kirkland, Wash.-based company said. “Cardea Solo is an affordable, patient friendly and nonintrusive device designed […]
J&J’s Ethicon wins FDA nod for Echelon circular stapler
Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon said today it won FDA 510(k) clearance for its Echelon circular powered stapler. The company touted new features of the recently cleared stapler, saying it was designed to reduce anastomotic complications during colorectal, gastric and thoracic cancer surgeries. “Ethicon is committed to reducing complications, which have a significant impact […]
What does FDA really mean when something is 510(k) exempt?
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 […]