Last year set a new record for FDA approvals of novel medical devices, continuing the upward trend seen over the past few years, according to the agency.

In 2018, the FDA greenlit 106 new devices—including premarket approvals and panel-track supplements; de novo and breakthrough 510(k) clearances; and humanitarian device exemptions—beating out 2017’s 40-year record of 98 devices.

Some of these include the world’s smallest mechanical heart valve, developed by Abbott and St. Jude Medical for newborns; the first blood test for detecting concussions and intracranial lesions, by Banyan Biomarkers; and the first artificial iris in the U.S., by HumanOptics.

The agency also spotlighted the 112 breakthrough device designations it has granted since the program launched in April 2015, with nine being approved or cleared in the last calendar year.

The FDA did adopt a new definition of “novel device” beginning this year, to include HDEs and breakthrough device 510(k) clearances, following changes made by the 21st Century Cures Act passed in December 2016. However, even under the old tabulation, 2018’s 101 novel approvals still outpaced the previous year’s 95 devices.

Source: www.fiercebiotech.com