FDA Has Authorized 56 Breakthrough Devices So Far

In the latest update on the FDA’s Breakthrough Devices program, the agency said that 56 medical devices that received breakthrough designations have gone on to gain marketing authorizations as of Sept. 30.

A total of 728 devices have gained the designation as of Sept. 30, 2022 — the end of the fiscal year — including devices originally designated under the agency’s Expedited Access Pathway. The agency granted a record 206 breakthrough designations for fiscal 2021, but that number dipped to 164 for fiscal 2022.

The last two devices in the program to gain marketing authorizations in September were Phagenesis’ Phagenyx System, an electrical stimulation device for treatment of stroke patients who have difficulty swallowing, and Magnus Medical’s Saint Neuromodulation system for treatment of major depressive disorder.

The top clinical areas to receive the designation have been cardiovascular (167), neurology (132), orthopedic (83), and gastroenterology and urology (55).

Launched in 2015, the Breakthrough Devices program targets devices for the treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The program aims to hasten development and regulatory review of the devices to give the public timelier access.