Why is this important?
Reason #1 - The "Breakthrough Device Designation" is new for Orthopedics. Active Implants is either the 1st or 2nd ortho company to ever to receive this designation. (see chart)
TO:Distribution of granted breakthrough device designation requests across common clinical specialties and medical device areas.
Reason #2 - Historically, the "Breakthrough Device Designation" yields a higher clearance rate (see chart)
TO: Summary data for breakthrough device designation requests.
Read below the FDA’s 2018 report to Congress about the Breakthrough Device program....
