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 […]
510(k)
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 […]
Pulse Biosciences seeks FDA 510(k) for PulseTx system
Pulse Biosciences (NSDQ:PLSE) said today that it submitted a 510(k) application to the FDA for its PulseTx nano-pulse stimulation system. The Burlingame, Calif.-based company’s PulseTx system uses short-duration electrical pulses directed at solid tumors to induce immunogenic cell death. The cell death process exposes the tumor cell antigens to the immune system, which triggers an […]
Medtronic wins extended FDA indication for bone cement
Medtronic (NYSE:MDT) said today that it won 510(k) clearance for its Kyphon Xpede bone cement for the fixation of pathological fractures of the sacral vertebral body using sacral vertebroplasty or sacroplasty. The regulatory win expands the product’s original indications beyond treating vertebral fractures due to osteoporosis, cancer or benign lesion. Nearly 54 million Americans suffer […]
Medtronic wins FDA nod for next-gen Linq ICM
Medtronic (NYSE:MDT) said today it won FDA 510(k) clearance for its next-gen Reveal Linq insertable cardiac monitor with TruRhythm Detection. The Linq ICM with TruRhythm Detection offers exclusive algorithms which the Fridley, Minn.-based company said resulted in a 95% reduction in false bradycardia episodes and a 47% reduction in false pause episodes compared with the […]
Nephros wins FDA nod for EndoPur endotoxin dialysis filter
Nephros (OTC:NEPH) said today it won FDA 510(k) clearance for its EndoPur 10″ endotoxin filter designed for dialysis systems. The River Edge, N.J.-based company said the newly cleared EndoPur 10″ filter is designed to produce hemodialysis quality water for dialysis systems, and fits into existing filter cartridge housings. Nephros touted the device as having the smallest […]
Neocis wins FDA nod for 1st dental robotic guidance system
Robotic medical device developer Neocis said today it won FDA 510(k) clearance for its Yomi robotic guidance system for dental implant procedures, touting it as the 1st of its kind to win a nod from the federal watchdog. The Yomi is a computerized navigational system designed to assist in both pre and intra-operative phases of […]