The US Food and Drug Administration’s Brendan O’Leary was passionate about technology from an early age.
“I first started learning how to program as a kid,” said O’Leary, the new acting director of the agency’s
In this revealing interview, the new acting director of the US FDA’s Digital Health Center of Excellence talks about his new role at the DHCOE, the big shoes he’ll have to fill now that former center head Bakul Patel is gone, the need for new regulatory frameworks for digital health – and how he helped repair the Hubble Space Telescope.

The US Food and Drug Administration’s Brendan O’Leary was passionate about technology from an early age.
“I first started learning how to program as a kid,” said O’Leary, the new acting director of the agency’s
This week, the FDA announced a new head of its device evaluation office; synthetic genomics firm Constructive Bio landed $58m in funding; and Natera got a permanent injuction against NeoGenomics Labs' RaDaR assay.
Tim Schmid, executive VP and worldwide chairman of J&J MedTech, expects Shockwave, acquired in April, and Abiomed, purchased in late 2022, to be “long-term gems” for the company. Cardiovascular is among higher-growth segments where J&J has concentrated investments in recent years, along with robotic surgical systems.
The US FDA has published a trio of draft guidance documents for its Assessment Scheme for Conformity Program, which began as a pilot in September 2020 to capitalize on the role of standards in the regulation of medical devices.
Inari Medical is updating use instructions for a clot-removing catheter due to the potential for serious adverse effects, including death.
AdvaMed president Scott Whitaker said the group is focused on the need for tariff stability in conversations with the Trump administration. The organization remains optimistic about other policy areas. New chairman and ResMed CEO Mick Farrell laid out his five priorities.
Class III devices and panel-track supplements approved by US FDA’s Center for Devices and Radiological Health. Data derived from FDA.gov. Updated weekly.
AdvaMed president Scott Whitaker said the group is focused on the need for tariff stability in conversations with the Trump administration. The organization remains optimistic about other policy areas. New chairman and ResMed CEO Mick Farrell laid out his five priorities.