Category: 510(k)
The FDA clears Biolase's WaterLase iPlus tissue laser in the U.S.
Biolase (NSDQ:BIOL) won 510(k) clearance from the FDA for its WaterLase iPlus, a laser used for soft-tissue orthopedic procedures.
The clearance opens up a $2.6 billion market opportunity for the WaterLase device, according to a company statement.
FDA regulators give Masimo a nod for its Rainbow acoustic monitoring sensor for pediatric use.
The FDA granted 510(k) clearance to Masimo (NSDQ:MASI) for its Rainbow acoustic monitoring sensor for use in children.
Previously cleared for adults, the device can now be used in the U.S. to monitor the respiration rate of pediatric patients.
Medtronic's new Viva portfolio of cardiac resynchronization therapy defibrillators help reduce heart failure hospitalizations by adapting continuously to a patient's heart rhythms.
With FDA clearances in hand, medical device titan Medtronic (NYSE:MDT) touted the launch of 2 lines of cardiac rhythm management devices that the company says can help reduce costs and enhance patient comfort.
With 510(k) clearance, French device maker Mauna Kea plans to begin immediate U.S. distribution of its AQ-Flex 19 miniprobe.
Mauna Kea Technologies (ENT:MKEA) landed FDA clearance for its AQ-Flex 19 mini-probe, which is already on the market in Europe. The device is designed to biopsy pancreatic cysts during endoscopic needle aspiration procedures in the digestive tract.
The FDA gives Spine Wave a nod for its StaXx IB intervertebral body fusion device.
Spine Wave won FDA clearance for its StaXx IB system, an intervertebral body fusion device. The privately held company said this expandable fusion device is differentiated from its flagship StaXx XD with the addition of bone graft chambers.
Minneapolis-based startup InterValve Inc. wins FDA clearance for its V8 aortic valvuloplasty balloon catheter.
Minneapolis-based InterValve Inc. won FDA clearance for its V8 aortic valvuloplasty balloon catheter, which features a "figure-8" shape that helps lock the device in place in the aorta, the company announced.
The FDA okay-ed the device for stand-alone balloon aortic valvuloplasty as well as for pre-dilation during transcatheter aortic valve implantation procedures, according to a press release.
U.S. healthcare regulators expand NxStage Medical's System One clearance to include high flow capabilities for home hemodialysis.
NxStage Medical (NSDQ:NXTM) touted FDA clearance for high flow capabilities for the company's System One home hemodialysis technology, a device the company calls the "only truly portable hemodialysis system cleared for home use."
The Lawrence, Mass.-based medical device maker plans to launch new higher flow System One devices later this year, according to a press release.
