Indigenous stroke device approved, commercial launch set for February 2026
An indigenously developed medical device for treating severe strokes has received regulatory approval in India based on domestic clinical trial data, officials said on Friday. The device, designed to remove blood clots and restore blood flow to the brain within 24 hours of stroke onset, is expected to be commercially launched in February 2026.
According to experts, timely removal of clots is critical in preventing long-term neurological damage and improving recovery outcomes for stroke patients. The device offers a cost-effective and locally manufactured alternative to imported thrombectomy systems, which are often expensive and less accessible in smaller hospitals.
Clinical trials conducted across multiple centres in India demonstrated the safety and efficacy of the device, paving the way for regulatory clearance. Healthcare authorities and neurology specialists have welcomed the approval, highlighting that it will strengthen stroke care infrastructure in the country and make advanced treatment more widely available.
