The Latest
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Illumina wins FDA approval for companion diagnostic cancer test
Physicians can use the test to identify people eligible for treatment with Bayer’s Vitrakvi and Eli Lilly’s Retevmo, which target cancers that have specific genetic features.
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Q&A
Insulet’s Trang Ly on overcoming ‘clinical inertia’ in diabetes care
Automated insulin delivery for Type 2 patients can help change minds among physicians who have been reluctant to prescribe pump therapy, the chief medical officer said in an interview.
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Boston Scientific receives CE mark for updated TAVR technology
Changes include the addition of a larger valve size that company executives have said will open up 25% of the market in Europe.
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Retrieved from UFP Technologies on August 27, 2024
UFP to buy device component maker AQF Medical, extending deal spree
AQF makes foam and thermoplastic components for use in medical devices and packaging.
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Insulet expands Omnipod 5 pump to people with Type 2 diabetes
The FDA clearance marks the first automated insulin delivery system for people with Type 2 diabetes.
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Inari updates label of clot removal device linked to 6 deaths
Inari recalled the catheter and revised instructions for use after reports of the device becoming entrapped or blocking patients’ lung arteries.
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Siemens Healthineers to grow PET imaging with purchase of Novartis assets
Siemens will pay 200 million euros for the manufacturing and distribution network of Novartis’ radiopharmaceutical molecular imaging business.
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Dexcom prices first over-the-counter glucose monitor
Known as Stelo, the device is intended for people who don’t take insulin and costs $89 per month.
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FDA seeks feedback on predetermined change control plans
The guidance describes changes companies can make to medical devices without filing a new 510(k) or premarket approval supplement.
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Defibtech recalls chest compression device linked to patient death
Customers are asked to return affected devices due to a problem in the motor that could stop compressions.
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Roche to increase global laboratory capacity for mpox testing
The World Health Organization has declared an mpox outbreak to be a public health emergency of international concern.
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Getinge to buy Paragonix organ-preserving tech for up to $477M
Getinge will pay $253 million in cash at closing, with additional payments expected to be made between 2024 and 2026 if certain milestones are met.