AdvaMed’s new online clock documents the time since CMS promised to replace MCIT, a program guaranteeing coverage for FDA-cleared breakthrough devices.
AdvaMed’s putting pressure on the Centers for Medicare and Medicaid Services to announce its final proposal to cover breakthrough devices.
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Industry waits to see if there will be a surge in demand for orthopedic and cardiology devices as IHI’s EU Ambulatory Surgical Centers proposal awaits sign-off.
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.
Germany’s incoming coalition government has reacted positively to industry’s calls for a dedicated medtech strategy to boost economic growth. Faster digitization, lower energy costs and “IVDR 2.0” are also on the in vitro diagnostic industry’s agenda.
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.
In an interview with Medtech Insight, Uttarwar breaks down how OneCell’s proprietary single-cell biopsy platform is rewriting the rules of cancer diagnostics – not just identifying cancer at the cellular level but predicting its potential return with unprecedented accuracy. He also shares how the company’s approach leverages single-cell biopsy technology and machine learning to spot signs of cancer’s return before it manifests clinically.
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.
An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.
