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1 week ago | 
medtechdive.com | Susan Kelly
This audio is auto-generated. Please let us know if you have feedback. The Food and Drug Administration’s attempt to increase regulatory scrutiny over laboratory developed tests appears to be dead, much to the relief of clinical labs. The FDA is unlikely to appeal the March 31 federal court order that set aside a final rule asserting the agency’s jurisdiction over LDTs, attorneys who handle regulatory matters said in interviews.
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1 week ago | 
medtechdive.com | Susan Kelly
This audio is auto-generated. Please let us know if you have feedback. As President Donald Trump’s tariff policies continue to evolve, medtech investors will be focused on companies’ plans to manage the impact on supply chains when they tune into first-quarter earnings calls starting this week.
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2 weeks ago | 
medtechdive.com | Susanna Vogel |Susan Kelly
This audio is auto-generated. Please let us know if you have feedback. A week after declaring “Liberation Day” and levying hefty tariffs on most of the country’s trading partners, President Donald Trump reversed course on Wednesday, announcing he will pause most reciprocal tariffs for 90 days. On its face, the pause is good news for the healthcare industry, as it offers companies some breathing room in which to make supply chain adjustments, analysts told Healthcare Dive.
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2 weeks ago | 
healthcaredive.com | Susanna Vogel |Susan Kelly
Provider groups and health systems warn tariffs will test healthcare’s fragile supply chain, threatening to disrupt patient care.
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2 weeks ago | 
medtechdive.com | Susanna Vogel |Susan Kelly
This audio is auto-generated. Please let us know if you have feedback. Healthcare industry groups and analysts are reeling after President Donald Trump unveiled a sweeping tariff policy on Wednesday that could impact global supply chains for everything from needles and catheters to diagnostic tests and glucose sensors. The policy adjustments include a universal baseline tariff of 10% effective April 5, and higher individual tariffs on some U.S. trading partners effective April 9.
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2 weeks ago | 
healthcaredive.com | Susan Kelly |Susanna Vogel
Lobby groups like the American Hospital Association and AdvaMed have so far failed to get medical devices and critical supplies carved out from the Trump administration’s tariffs.
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3 weeks ago | 
medtechdive.com | Susan Kelly |Susanna Vogel
This audio is auto-generated. Please let us know if you have feedback. AdvaMed, one of the medical device industry’s largest trade groups, reiterated its opposition to broad-based tariffs Wednesday, saying the actions would hurt innovation, cost jobs and increase healthcare costs, after the Trump administration announced new duties on most U.S. trading partners. “The medtech industry should be exempted from these tariffs,” CEO Scott Whitaker said in a statement.
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3 weeks ago | 
medtechdive.com | Susan Kelly
This audio is auto-generated. Please let us know if you have feedback. CMR Surgical said Wednesday it closed a financing round worth more than $200 million to support commercializing the robot maker’s Versius soft tissue system. The Cambridge, U.K.-based company now has its sights on the U.S. market, after winning Food and Drug Administration de novo authorization for the robot in October with an initial indication for gallbladder removal surgery.
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3 weeks ago | 
medtechdive.com | Susan Kelly
This audio is auto-generated. Please let us know if you have feedback. Research evaluating technologies to treat heart valve disease was a highlight of the American College of Cardiology’s annual conference, which wrapped up Monday in Chicago.
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3 weeks ago | 
medtechdive.com | Susan Kelly
This audio is auto-generated. Please let us know if you have feedback. A Texas federal court on Monday struck down the Food and Drug Administration’s new rule regulating laboratory developed tests as medical devices in a victory for the clinical lab industry. Judge Sean Jordan, for the U.S. District Court for the Eastern District of Texas, vacated the FDA’s final rule in its entirety. The court remanded the matter to newly confirmed Health and Human Services Secretary Robert F.
