Expert: Cybersecurity Requirements In Omnibus Bill Will Provide Visibility For Industry
Medtech Connect Episode 3: A Deep Dive Into The FDA’s Cyber Reforms
In this episode of Medtech Connect, Medtech Insight regulatory reporter Hannah Daniel interviews Scott Trevino, senior vice president of cybersecurity at TRIMEDX, about the new cybersecurity oversight given to the FDA as a part of the Omnibus Appropriations bill passed in December.

More from Regulation
HHS Secretary Robert F. Kennedy, Jr. is asking the public to help cut waste across the government’s health agencies. Kennedy announced a 60-day comment period allowing the public to take part in a broader federal initiative to reduce regulations and increase transparency.
The intricate assembly of medical devices, often involving over 1,000 globally sourced components, faces severe disruption due to new US tariffs. These barriers could halt production and devastate small and medium-sized enterprises (SMEs), MedTech Europe’s CEO, Oliver Bisazza, warns in an interview with Medtech Insight.
With medtech businesses typically managing investment cycles on a three- to five-year basis, local regulatory processes and forward costs of market entry must offer an attractive environment in which companies can plan for growth, says McDermott Will and Emery’s partner and head of healthcare and life sciences, Sharon Lamb. Broad-scale improvements to NICE’s evaluation offerings would similarly enhance the UK’s value to innovators.
While MedTech Europe sharpens its focus on what the EU most urgently needs to advance the medtech market in four targeted measures, the European Commission has also unveiled four priorities for 2025.