The Latest
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CMS, FDA unveil speedier Medicare coverage pathway for breakthrough devices
The pathway is designed to reduce the delay between FDA authorization and Medicare coverage for certain Class II and Class III breakthrough medical devices.
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AcuityMD raises $80M to add AI capabilities to medtech sales software
The company plans to introduce AI agents for personas such as sales reps, leadership and marketing teams.
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Boston Scientific slashes 2026 guidance
CEO Mike Mahoney told investors that the lowered forecast reflects challenges for several businesses, including electrophysiology and Watchman.
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Tandem recalls Mobi insulin pumps over software malfunction
A malfunction may cause insulin delivery to stop. Tandem instructed users to update their pump software as soon as possible.
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CDRH Director Tarver previews AI guidance at AAMI event
Michelle Tarver said the device center plans to finalize guidance on AI lifecycle management and provide some initial thoughts on generative AI following an advisory committee meeting last year.
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Intuitive Surgical lifts 2026 outlook for da Vinci robot procedure growth
The company, whose shares climbed nearly 8% Wednesday morning, also said a recent cyber incident has been contained and did not significantly affect first-quarter results.
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Apple fends off Masimo challenge to Apple Watch redesign
Apple can continue selling redesigned Apple Watches with a blood oxygen feature after the International Trade Commission concluded the products do not infringe Masimo patents.
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Medtronic leads $100M investment in Pulnovo Medical
Medtronic formed a commercial agreement with Pulnovo alongside its investment.
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MiniMed posts double-digit sales growth, widening net loss
New glucose sensors and a partnership with Abbott are expected to drive sales growth at MiniMed, BTIG analyst Marie Thibault wrote.
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RFK Jr. defends HHS tenure, 12% proposed budget cut
Republicans largely praised the HHS secretary’s track record during a marathon of House hearings last week, but some GOP lawmakers raised concerns about proposed budget cuts to the National Institutes of Health.
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Medtronic closes $585M purchase of CathWorks
The deal is the second tuck-in acquisition this year for Medtronic, which has signaled its intent to pursue more M&A in its core business lines.