The FDA approved, cleared or authorized a record high of 132 novel medical devices in 2020, with pandemic-related emergency use authorizations (EUAs) adding significantly to the total.
That compares with 29 novel devices the agency authorized in 2010, according to a new article by officials from the agency’s Center for Devices and Radiological Health (CDRH).
Novel devices include those brought to market through the premarket approval (PMA), humanitarian device exemption (HDE) and de novo pathways, as well as a subset of those that gain 510(k) clearance or an EUA. The FDA defines “novel” devices as those that address an unmet need or may be safer or more effective than currently available alternatives. For 2020, the agency included first-of-a-kind devices authorized under EUAs as novel devices.
Some novel devices authorized in 2020 include:
- Akili Interactive’s EndeavorRx video game for children with attention deficit hyperactivity disorder (ADHD).
- Miach Orthopedics’ anterior cruciate ligament (ACL) implant as an alternative to ACL reconstruction to treat ACL tears.
- Medtronic’s Carpediem, the first continuous renal replacement therapy device for a lower-weight pediatric population with sudden or temporary loss of kidney function or fluid overload.
- Caption Health’s AI-assisted cardiac ultrasound software designed to guide the user to capture quality diagnostic images.The
- Medtronic (NYSE:MDT) MiniMed 770G hybrid closed loop-diabetes management system for Type 1 diabetes patients aged 2 to 6 years.
“While the number of novel devices seen in 2020 cannot be attributed to any single factor, we know that the volume of EUAs for novel devices issued in 2020 played a role,” said CDRH director Jeff Shuren and William Maisel, director of CDRH’s Office of Product Evaluation and Quality, in the article. “Of the 625 EUAs the FDA issued for medical devices in 2020, such as tests and sample collection devices, personal protective equipment (PPE), ventilators, and other types of devices as part of our COVID-19 response, several were issued for novel medical devices, including … novel in vitro diagnostic devices for COVID-19.”
You can read the article here.