Moximed MISHA Knee wins FDA clearance, finally.

"After $183M in funding and 17 years of work, and 4 redesigns of the device, Moximed has finally won FDA clearance. This is why I hate the Class III pathway in orthopedics." --Tiger

Full Press Release Below

FDA Authorizes Marketing of MISHA™ Knee System for People Suffering from Knee Osteoarthritis

Implantable shock absorber (ISA) relieves pain and improves function in people ineligible for, or unwilling to undergo, joint replacement MISHA Knee System is implanted during an outpatient procedure; it's the first and only device of its kind for people with symptomatic knee OA More than 32 million people in the United States are affected by osteoarthritis

Moximed, a medical device company on a mission to improve the standard of care for people with knee osteoarthritis (OA), today announced that the U.S. Food and Drug Administration (FDA) granted marketing authorization of the MISHA™ Knee System, an implantable shock absorber (ISA) for the knee. The MISHA Knee System is indicated to treat people with medial knee OA who failed to find relief from non-surgical or surgical treatment, continue to experience pain that interferes with daily activities, and ...