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 […]
Bioness wins CE Mark for L300 Go FES system
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 […]
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.
FDA clears Bioness’ StimRouter device for chronic pain
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.
Cerebral Palsy: Bioness touts FDA win for treatment of foot drop in children
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.
Bioness Inc. NESS H200 Wireless System for Hand Paralysis receives CE Mark and FDA approval
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.