A letter from Suzanne Schwartz affirms that the FDA approves the extension of a copyright-law exemption that lets third parties access software in medical devices for repair or maintenance, but not for modifications that could affect device safety.
The US Food and Drug Administration is backing the extension of a copyright enforcement policy that allows access to medical device software, including for cybersecurity purposes.
Join thousands of industry professionals who rely on Medtech Insight for daily insights
Already a subscriber?
US President Trump has imposed sweeping tariffs that encompass medtech. These are expected to drive up costs, disrupt supply chains and hinder innovation, likely driving the EU to seek new trade partnerships to mitigate the impact.
Energy and Commerce Health Subcommittee Democrats focus on criticizing HHS Secretary Kennedy’s RIF announcement, including 3,500 FDA jobs among cuts across HHS agencies. Representatives were left wondering if user fee programs would continue, even if reauthorized.
A federal judge in Texas delivered what is most likely a fatal blow to the US FDA’s final rule, which would have regulated lab-developed tests as medical devices.
A planned merger between medical device coating manufacturers Surmodics and Biocoat is facing an antitrust lawsuit from the US Federal Trade Commission. The FTC believes the move would create an illegal monopoly.
The deadline for comments is 30 June 2025
Dexcom announced it received US clearance for its 15-day CGM, which has a MARD of 8.0% and is expected to launch in the second half of 2025 to allow for integration with insulin pumps.
Well over 200 European standards need harmonizing under the MDR. But only around 12% have been attended to so far.
