When the White House Office of Management and Budget, or OMB, sent the US FDA’s draft harmonized Quality System Regulation back to the agency after only 35 days of review, it raised some eyebrows in industry. Check out what experts are saying about the reg review time frame in this week’s podcast.
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The EU’s Artificial Intelligence Act, which entered into force on 1 August 2024, is already facing turbulence.
Manufacturing shifts, financial planning, and supply chain changes are among the adjustments that medtech leaders are making to Trump-era tariffs. Medtech Insight’s review of first-quarter earnings calls reveals how firms are navigating the impact and uncertainty of evolving trade policies.
The US FDA has given up on its effort to regulate lab-developed tests as medical devices, at least for now. The agency will not appeal a decision from the Eastern District of Texas that tossed out the FDA’s final rule, leaving the agency with few cards.
Second submission window for joint scientific consultations on a procedure to help prepare for joint clinical assessments will open from 2 to 30 June 2025.
Guardant Health’s methylation-based blood test – Shield MCD – showed a specificity of 98.6% and sensitivity of 75% across eight cancer types in its clinical validation data presented at ASCO.
US FDA Commissioner Marty Makary says the agency’s generative AI tool ‘Elsa’ will allow employees across the FDA to work more efficiently. The commissioner says Elsa’s launch comes ahead of schedule following a successful pilot program.
Modifying or doing away with the EU medtech recertification requirement is far from straightforward. Four experts from an EU national authority, an EU notified body trade association and industry, plus a well-known medtech consultant, reflect on how to move forward.
