Category: 510(k)Syndicate content

Biolase gets FDA nod for new tissue laser

May 13, 2013 by Sony Salzman

The FDA clears Biolase's WaterLase iPlus tissue laser in the U.S.

Biolase

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.

Masimo lands FDA win for pediatric acoustic sensor

May 8, 2013 by Sony Salzman

FDA regulators give Masimo a nod for its Rainbow acoustic monitoring sensor for pediatric use.

Masimo

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 touts FDA win for cost-saving heart rhythm implants

May 6, 2013 by Arezu Sarvestani

Medtronic's new Viva portfolio of cardiac resynchronization therapy defibrillators help reduce heart failure hospitalizations by adapting continuously to a patient's heart rhythms.

Medtronic logo

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.

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FDA gives Mauna Kea the green light for its optical biopsy miniprobe

May 3, 2013 by Sony Salzman

With 510(k) clearance, French device maker Mauna Kea plans to begin immediate U.S. distribution of its AQ-Flex 19 miniprobe.

MaunaKea

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.

Spine Wave wins U.S. clearance for its body fusion device

May 2, 2013 by Sony Salzman

The FDA gives Spine Wave a nod for its StaXx IB intervertebral body fusion device.

SpineWave

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.

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Early-stage InterValve wins FDA clearance for V8 valvuloplasty balloon catheter

April 30, 2013 by Arezu Sarvestani

Minneapolis-based startup InterValve Inc. wins FDA clearance for its V8 aortic valvuloplasty balloon catheter.

InverValve Inc. logo

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.

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FDA clears NxStage Medical's high-flow home hemodialysis

April 30, 2013 by Arezu Sarvestani

U.S. healthcare regulators expand NxStage Medical's System One clearance to include high flow capabilities for home hemodialysis.

NxStage logo

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.

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