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Bioness Inc.

7 medtech stories we missed this week: May 12, 2017

May 12, 2017 By Danielle Kirsh

From Bioness’s new distribution deal to InBrace’s launch of new braces technology, here are 7 medtech stories we missed this week but thought were still worth mentioning. 1. Obalon receives approval to commercialize in Middle East Obalon Therapeutics announced in a May 11 press release that it has received regulatory approvals in select Middle East […]

Filed Under: Business/Financial News, Patient Monitoring, Regulatory/Compliance, Research & Development, Surgical Tagged With: Bioness Inc., InBrace, LensAR Inc., MedTech, Obalon Therapeutics, Ottobock, SRS Medical, Teleon Surgical, ZipLine Medical

Bioness wins CE Mark for L300 Go FES system

April 25, 2017 By Fink Densford

Rehabilitation device maker Bioness said today it won CE Mark approval in the European Union for its L300 Go functional electrical stimulation system. The L300 Go FES system is designed to help increase mobility in individuals with lower limb paralysis or weakness, and the company claims it is the 1st such system to offer comprehensive […]

Filed Under: Neuromodulation/Neurostimulation, Regulatory/Compliance Tagged With: Bioness Inc.

Bioness launches clinical trial for StimRouter in overactive bladder

March 30, 2015 By Mark Hollmer Leave a Comment

Bioness launches clinical trial for StimRouter in overactive bladder

Bioness last week said it’s making progress with a Canadian study of its StimRouter neuromodulation device designed to expand the number of conditions for which it can be used for treatment.

Filed Under: Gynecological, Neuromodulation/Neurostimulation, News Well, Urology Tagged With: Bioness Inc., Clinical Trials

FDA clears Bioness’ StimRouter device for chronic pain

February 25, 2015 By Val Kennedy Leave a Comment

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The FDA has granted market clearance for Bioness' Stimrouter for the treatment of chronic peripheral pain.

The company describes StimRouter as a minimally invasive, implanted neuromodulation device that sends electrical signals to the pain's point of origin. The device is controlled by a wireless, hand-held unit.

Filed Under: Food & Drug Administration (FDA), Neuromodulation/Neurostimulation, News Well Tagged With: Bioness Inc., Regulatory

Cerebral Palsy: Bioness touts FDA win for treatment of foot drop in children

January 25, 2013 By MassDevice staff Leave a Comment

Bioness

Valencia, Calif.-based neurostimulation devices maker Bioness Inc. won the FDA’s OK for its L300 Foot Drop system, the 1st FDA-cleared device of its kind for treating children suffering from foot drop as a result of cerebral palsy or other brain injuries.

The L300 neurostimulation device, which is available for sale immediately, "sends low-level electrical stimulation to the nerves in the lower leg which control the muscles responsible for lifting the foot," according to a prepared release.

Filed Under: 510(k), Food & Drug Administration (FDA), News Well, Orthopedics, Regulatory/Compliance Tagged With: Bioness Inc.

Bioness Inc. NESS H200 Wireless System for Hand Paralysis receives CE Mark and FDA approval

October 5, 2011 By MassDevice Leave a Comment

Wireless capability allows for seamless integration of device into daily life, increasing therapy time and patient compliance

VALENCIA, Calif., Oct. 4, 2011 /PRNewswire/ — Bioness Inc. today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) and CE Mark Approval by the European Union for its NESS H200® Wireless Hand Rehabilitation System. This new wireless system allows patients to better integrate the NESS H200 into daily life, increasing therapy time which may lead to increased patient compliance and better outcomes.

Filed Under: Uncategorized Tagged With: Bioness Inc., Press Release

pSivida, Alimera want FDA to give eye treatment another look | Regulatory roundup

May 13, 2011 By MassDevice staff Leave a Comment

Clearances roundup

pSivida Corp. (NSDQ:PSDV) and Alimera Sciences Inc. (NSDQ:ALIM) are having another go at gaining approval from the FDA for a drug/device combination to treat diabetic macular degeneration.

Filed Under: 510(k), Food & Drug Administration (FDA), News Well Tagged With: Abbott, Alimera Sciences, Avinger, Bioness Inc., iCad Inc., Insys Therapeutics Inc., Meridian Bioscience Inc., pSivida Corp.

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