The Latest
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Medtronic inks distribution deal with Contego with option to buy firm
Medtronic will be the exclusive U.S. distributor of Contego Medical’s portfolio, which includes a carotid stent system and thrombectomy devices.
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Illumina, Nvidia team to use AI in foundation models
Nvidia’s partnership with the gene sequencing company is one of several healthcare collaborations revealed Monday by the computing giant.
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EU medtech regulations reducing options for patients, companies say
Stakeholders branded the MDR and IVDR rules “unreasonably complicated,” “terrible for EU patients and doctors” and “a mess.”
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Deep Dive // 2025 outlook
5 medtech trends to watch in 2025
After a busy 2024, experts called out competition in soft tissue robotics, uncertainty from a Trump White House and continued success for pulsed field ablation as trends to watch this year.
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More hospitals need to assess predictive models for accuracy, bias: Health Affairs
Just 61% of hospitals surveyed evaluated models for accuracy on their own data, and less than half evaluated the models for bias.
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Eko Health names Justin Spencer as CFO
Spencer’s arrival at Eko comes months after the digital health company appointed his former colleague Brent Lang to its board of directors.
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Fire1 raises $120M to trial heart failure management system
Medtronic and Novo Holdings were among the investors in the funding round.
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J&J pauses Varipulse PFA cases in US
The temporary halt to investigate reported neurovascular events comes two months after Johnson & Johnson won FDA approval for the pulsed field ablation system.
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Medtronic inks exclusive deal to sell Kuros bone graft device
In the five-year agreement, Medtronic will be the exclusive sales agent for Kuros' product in certain U.S. spine geographies.
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Boston Scientific to buy remaining Bolt Medical stake for up to $664M
The deal for Bolt, developer of an intravascular lithotripsy system to treat coronary and peripheral artery disease, continues Boston Scientific’s brisk run of acquisitions.
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Beta Bionics, maker of ‘bionic pancreas,’ files for IPO
Beta Bionics did not disclose the number of shares it will offer or a price range.
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FDA finalizes guidance on device shortage reporting rules
The final version adds information on the devices affected by the guidance and the impact of revised legislation on voluntary notifications.
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Stryker to buy Inari Medical for nearly $5B
Stryker made several small deals last year but lacked a larger acquisition like its nearly $5 billion proposal for Inari Medical.
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FDA aims to stem AI device bias, boost transparency in draft guidance
The document follows the agency’s first digital health advisory meeting and a final guidance on postmarket updates to AI devices.
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Outset Medical to pay down debt after raising nearly $300M
Stifel analyst Rick Wise said the financing, a combination of private stock placement and new loans, should help the dialysis device maker return to revenue growth.
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FDA issues much-anticipated guidance on pulse oximeters
The FDA released the guidance in response to concerns that the devices are less accurate in people with darker skin pigmentation.
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FDA posts early alert about safety risk of Medline’s fluid delivery sets
The agency issued the alert as part of a pilot to improve the timeliness of communications about actions it believes are likely to be high-risk recalls.