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In this week’s Digital Health Roundup, Medtech Insight’s Marion Webb talks about her interview with GE HealthCare’s chief AI officer Parminder Bhatia about his vision for AI in health care and other highlights from HLTH. Natasha Barrow discusses her interview with Owkin on the EU AI Act and highlights Click Therapeutics’ latest clinical results.

AdvaMed is calling on Medicare to provide coverage for supplemental screenings for women with dense breasts, an anatomical characteristic that puts them at a higher risk for cancer. The trade group says the lack of coverage for additional imaging results in many women not receiving potentially lifesaving follow-up.

During the Medtech Conference in Toronto, a panel of industry leaders discussed the gaps that remain in women’s healthcare and said innovation can help narrow them.

In her inaugural address to the medtech industry during the Medtech Conference, acting US CDRH director Michelle Tarver described her mission-driven approach.

As the 6 May deadline to implement the FDA’s final rule on lab-developed tests approaches, attempts to stop the rule from taking effect are set to play out in court. A panel of experts discussed the potential impact of these legal efforts, should they be successful, at the Medtech Conference in Toronto.

During the Medtech Conference in Toronto, three of the industry’s leading CEOs shared their insights into the rapidly changing landscape of health care and how the latest advancements have the potential to make life better for patients everywhere.

The AI/ML pre-determined change control plan final guidance will include plans for agency-wide training for the implementation of PCCPs, an FDA deputy director said at the Medtech Conference.

CDRH is on track to meet its MDUFA V goals, seeing a steady return to pre-pandemic levels of device authorizations and submissions.

Investors and business executives weighed in on the FDA’s proposed rule on LDTs during a panel at the Medtech Conference on 9 October. 

As diagnostics have become more technologically advanced and are used more frequently in detecting diseases, uniform regulatory standards have become necessary, according to a panel of experts discussing testing reform at the MedTech Conference in Boston.