The Latest
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Courtesy of Insightec
Medtech venture investment recovery continues, but startup M&A remains limited: Pitchbook
Acquisitions of late-stage VC startups have been rare, a fact Pitchbook attributed to “ongoing price gaps between buyers and sellers.”
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SDI Productions via Getty Images
European heart group recommends renal denervation for some patients
The European Society of Cardiology said the treatment may be considered for certain patients with uncontrolled, drug-resistant high blood pressure but outlined lingering concerns.
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andresr via Getty Images
AI still the most exciting emerging technology for healthcare: survey
AI was the most compelling new technology for the fourth year in a row, with leaders also saying the technology had shown the most improvement, according to the Center for Connected Medicine.
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Courtesy of Grail
Illumina avoids fine for Grail purchase in European court victory
Illumina will avoid a penalty of 432 million euros after a court ruled the European Commission did not have jurisdiction to challenge the company’s Grail acquisition.
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Permission granted by Nasdaq
Embecta gets FDA nod for insulin patch pump
Embecta’s first patch pump features a larger insulin reservoir, based on feedback from people with Type 2 diabetes.
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Win McNamee/Getty Images via Getty Images
ARPA-H program to focus on AI degradation in medical tools
The agency will fund work to identify and auto-correct AI-enabled tools that are misaligned with their underlying training data.
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Permission granted by Medtronic
Medtronic’s chief medical officer of acute care and monitoring departs for new role
Sam Ajizian leaves Medtronic six months after the company reversed a plan to split off its patient monitoring business.
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andresr via Getty Images
Pathology group sues to block FDA lab test rule
The Association for Molecular Pathology is the second lab trade group urging the courts to void an FDA policy expanding oversight of diagnostic tests.
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Sarah Silbiger via Getty Images
FDA finalizes Voluntary Malfunction Summary Reporting guidance
The agency clarified when companies can submit device malfunction reports in a quarterly summary, instead of individual reports every 30 days.
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Courtesy of Penumbra
Penumbra axes virtual reality division, will lay off 71 people
CEO Adam Elsesser told investors the company’s focus needs to be on its core thrombectomy business as it cut its sales forecast for 2024.
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Courtesy of Qiagen
Qiagen, AstraZeneca expand companion diagnostic pact beyond cancer
The goal is to enable specialty care providers to perform genotyping while patients are undergoing routine clinical examination.
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Rob Carr / Staff via Getty Images
Johns Hopkins, CareFirst, Techstars launch healthcare AI accelerator
The 13-week program will offer funding and guidance to up to 12 health tech, medtech and biotech startups working on AI tools.
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Courtesy of Illumina
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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Permission granted by Insulet
Q&AInsulet’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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Courtesy of Boston Scientific
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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Courtesy of Insulet
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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Kahan Shan via Getty Images
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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Courtesy of Siemens Healthineers
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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Courtesy of Dexcom
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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Sarah Silbiger via Getty Images
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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Sarah Silbiger via Getty Images
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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Courtesy of Roche
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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Courtesy of Getinge
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.
