A medical technology device that helps people regain hand function after a stroke has passed a major hurdle to enable its sale in India.
IRegained is reporting it's completed registration with the Central Drugs Standard Control Organisation (CDSCO), a government entity that oversees approval of drugs, medical devices and treatments in India.
The company, which is based in Sudbury, makes the MyHand system, which prompts patients to perform a series of hand movements that encourages a return to function that may have been lost following a stroke.
“This marks a major milestone in our journey to scale globally and brings us one step closer to transforming the lives of millions of stroke and brain injury survivors across the IndoPacific region,” the company said in a July 29 social media post.
“We are excited to begin commercial operations in India and partner with clinicians, hospitals, research institutes and rehabilitation centres to expand access to this life-changing technology in the globe's fastest growing large economy.”
MyHand has already been approved for sale in Canada and the U.S. and is being used at hospitals and medical centres across North America.
In 2024, the company announced it had reached a distribution agreement with Performance Health to market, sell and distribute its product in the U.S.
Earlier this year, the company struck a similar agreement with UpCare Partners and Associates to distribute the device in Canada.
As the company expands its market share, assembly of the device will move to a Toronto facility that meets the licensing requirements of Health Canada and the FDA; however, IRegained's headquarters, which will support development, shipping, and customer service, will remain in Sudbury.
