As MD+DI reported last month, FDA recently authorized the IpsiHand System, pictured above.
The IpsiHand is a breakthrough device for patients 18 and older undergoing stroke rehabilitation to facilitate muscle re-education, and for maintaining or increasing range of motion. The Neurolutions IpsiHand Upper Extremity Rehabilitation System is a brain-computer interface device designed to assist in rehabilitation for stroke patients with upper extremity (hand, wrist, and arm) disability.
Neurolutions CEO Leo Petrossian, PhD, and Eric C. Leuthardt, MD, the company's co-founder and chief scientific officer, joined us for this episode of Let's Talk Medtech to share some insight into the design and engineering considerations for the device, as well as some lessons learned regarding FDA's breakthrough device designation pathway. Click the player below to listen to the conversation.
For more information about the IpsiHand System, visit the Neurolutions' website.