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Many of the hundred-plus commenters to the FDA's draft guidance on AI in medical product regulation said the document was a good start but needed additional clarity and more concrete examples. Stakeholders recommended the inclusion of case studies, metrics, and clearer guidelines to enhance the utility of the guidance, which is seen as a vital step for AI integration in healthcare.

HHS Secretary Robert F. Kennedy Jr. urged FDA staff to resist the “deep state” and “crony capitalism,” and focus on improving the health of America’s children. “You're not here to take orders,” he said and urged FDA staff to speak up if they see wrongdoing.

The new telework policy returns to the pre-COVID-19 pandemic standard, but still requires reviewers to be at White Oak for sponsor meetings and divisions to have an in-office presence every day.

Will challenges in the way of designations of notified bodies that assess AI-enabled medical devices create delays and bottlenecks and slow EU medtech innovation?

A change of government, hospital reform and a drive towards healthcare digitization are keeping German medtech manufacturers on their toes. Making the MDR more user-friendly and winning support for a medtech strategy are arguably bigger priorities. US export tariffs have also pushed their way onto the agenda. BVMed chief executive Marc-Pierre Möll puts it all into context.

“We believe [the SAPIEN M3] launch alongside PASCAL and EVOQUE will help support the company’s target of $2bn in transcatheter mitral and tricuspid therapies sales by 2030,” noted analysts from Leerink Partners.

OneCell’s co-founder Uttarwar discusses clinical validation milestones, CLIA certification, and the startup’s strategic roadmap – from hospital partnerships in India to biopharma collaborations in the US.

Reimagine Care teamed up with MedStar Health to support cancer patients at home via an AI assistant and clinical support. Reimagine Care’s data suggests its platform can save cancer centers up to $1m annually per full-time oncologist panel and reduce ED visits by 30%.

“Infectious disease should be treated in the community, not in hospitals,” Alex Batchelor, Pictura Bio CEO, told Medtech Insight at the Anglonordic Life Science Conference on 3 April in London.

“Infectious disease should be treated in the community, not in hospitals,” Alex Batchelor, Pictura Bio CEO, told Medtech Insight at the Anglonordic Life Science Conference on 3 April in London.

Biotech and pharma are increasingly clear about one thing: They need diagnostics. But with prices suppressed, how have diagnostics companies proven their utility without going under?

Nawal Ouzren, Sensorion CEO and director, shared the latest industry reaction to US FDA layoffs at the McDermott Will & Emery European Health and Life Sciences Symposium in Paris.