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In this two-part series, FDAnews examines the dramatic impact of artificial intelligence (AI) on medical devices and the significant challenges it presents for regulators. Part 1 is an overview of the use of AI in medical devices.Read More
The FDA has granted Pixium Vision Breakthrough Device status for its Prima System, an investigational device for restoring partial vision for people with blindness caused by dry age-related macular degeneration (AMD). Read More
A bipartisan group of U.S. lawmakers has reintroduced proposed legislation to “modernize the review process for diagnostic testing” and clarify the regulatory authority between the FDA and the Centers for Medicare and Medicaid Services (CMS). Read More
Modifications needed to continually improve software functions for artificial intelligence (AI)-enabled medical devices must be made “in a manner that ensures the continued safety and effectiveness of the device,” the FDA emphasized in a draft guidance on predetermined change control plans (PCCPs) released Thursday. Read More
If the FDA is forced to go back to fiscal 2022 levels — as House Republicans are proposing — there will be fewer inspections and many new medical products won’t get approved, said FDA Commissioner Robert Califf during a fiscal 2024 budget hearing on Wednesday. Read More
A bipartisan group of members of the U.S. House of Representatives introduced a bill on Tuesday requiring Medicare to cover all devices that have an FDA Breakthrough Designation for four years while the FDA and the Centers for Medicare and Medicaid Services (CMS) make a final coverage determination. Read More
Starting March 29, new applications to the FDA for a “cyber device” must identify any vulnerabilities and include a plan for ongoing security throughout the device’s life, the FDA said in a final guidance released yesterday. Read More