Israeli firm wins FDA clearance for stroke device

מתוך medicontext.co.il

TEL AVIV (Reuters) – Israel's Neuromuscular Electrical Stimulation Systems Ltd (NESS) said on Monday the US Food and Drug Administration has approved use of its neuro-prosthetic device, the Handmaster, for stroke victims.

The device helps activate the impaired or paralysed hand of a person who has suffered a stroke through low-level electronic pulses that stimulate the neuromuscular system.

The Handmaster, which is designed for home use, is currently marketed in Israel and the Netherlands.

"We expect to have the product available in the US by the second quarter of 2002," NESS Chief Executive Shmulik Shany said in a statement. "We are also studying the return of hand function in the traumatic brain injury group to go along with this clearance and a previous one in the spinal cord injured population."

The company did not estimate potential sales but said more than one million stroke survivors in the United States alone could benefit from the device. The global market for such medical devices is $10 billion a year, the company added.

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