https://www.medtechdive.com/news/device-to-preserve-donor-lungs-wins-fda-approval/553721/
Device to preserve donor lungs wins FDA approval | MedTech Dive
The system could expand availability of donor lungs by preserving the organ for up to five hours, giving the transplant team time to reassess marginal lungs...
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https://www.medtechdive.com/news/Medtronic-Hugo-FDA-submission-urology/746489/
Medtronic submits Hugo soft tissue robot for FDA approval | MedTech Dive
William Blair analyst Brandon Vazquez said 2025 could be the first year market leader Intuitive Surgical will face meaningful U.S. competition.
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https://www.medtechdive.com/news/abbott-heart-device-for-premature-babies-wins-fda-approval/546051/
Abbott heart device for premature babies wins FDA approval | MedTech Dive
The device for sealing a hole in the heart of premature infants is smaller than a pea and can treat newborns weighing as little as 2 pounds.
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https://www.medtechdive.com/news/BD-BDX-Q2-earnings-Alaris/649452/
BD raises full-year forecasts again, expects Alaris infusion pump approval | MedTech Dive
The company said revenue increases in a number of its product lines were faster than market growth rates, suggesting it’s gaining share.
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https://www.medtechdive.com/news/PFA-market-Boston-Scientific-Medtronic-JNJ/733203/
The PFA race is heating up. Here’s where the market stands after J&J’s approval. | MedTech Dive
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https://www.medtechdive.com/news/saturated-oxygen-treatment-for-heart-attack-wins-fda-approval/552095/
Saturated oxygen treatment for heart attack wins FDA approval | MedTech Dive
The catheter-based device from Irvine, California-based TherOx aims to reduce muscle damage by delivering hyperbaric levels of oxygen to heart tissue.
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https://www.medtechdive.com/news/jjs-pulsed-field-ablation-ce-mark-europe/708881/
J&J’s pulsed field ablation system secures European approval | MedTech Dive
The device maker will vie against rivals Boston Scientific and Medtronic in the market for the new treatment for atrial fibrillation.
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https://www.medtechdive.com/news/Surmodics-Abbott-ABT-SRDX-balloon-layoffs-PAD/642379/
Abbott balloon device partner Surmodics cuts jobs after FDA approval delay | MedTech Dive
The workforce reduction, one of a growing number in the medtech sector, comes after the agency requested more data in a premarket review of the company’s...
fda approvalabbottballoondevicepartner
https://www.medtechdive.com/news/boston-scientific-farapulse-approval-tavr-launch-delay/706199/
Boston Scientific nets Farapulse approval, pushes back US TAVR launch | MedTech Dive
The device maker disclosed it will start the highly anticipated launch of the AFib ablation device, but approval for its aortic valve replacement implant will...
pushes backbostonscientificnetsapproval
https://www.medtechdive.com/news/cardiva-wins-fda-approval-for-its-vascular-closure-system/544733/
Cardiva wins FDA approval for its vascular closure system | MedTech Dive
The Santa Clara, California-based company succeeded in its PMA application and can now market the Vascade MVP device for use in electrophysiology procedures.
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https://www.medtechdive.com/news/teleflex-granted-fda-approval-for-vascular-closure-device/547777/
Teleflex granted FDA approval for vascular closure device | MedTech Dive
The product is designed to seal femoral punctures following vascular access medical procedures.
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https://www.medtechdive.com/news/gottlieb-fda-pursuing-faster-approval-path-for-diagnostics/532375/
Gottlieb: FDA pursuing faster approval path for diagnostics | MedTech Dive
The agency chief said it should focus its premarket reviews on a subset of higher risk or highly novel tests, companion diagnostics and tests for home use.
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https://www.medtechdive.com/news/stryker-wins-approval-for-brain-aneurysm-stent-system/555221/
Stryker wins approval for brain aneurysm stent system | MedTech Dive
The product, designed to treat wide-neck intracranial aneurysms, adds to the company's rapidly growing neurovascular portfolio.
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https://www.medtechdive.com/news/guardant-fda-approval-Shield-colon-cancer-blood-test/722665/
Guardant wins FDA approval for colon cancer blood test | MedTech Dive
Colorectal cancer screening rates could increase if the Shield test appeals to people who have avoided colonoscopies or stool-based tests, the company said.
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https://www.medtechdive.com/news/edwards-tavr-china-sapien-3-approval/579403/
Edwards wins approval to introduce Sapien 3 valve in China | MedTech Dive
The transcatheter heart device specialist has been eyeing the wealthy, aging nation's untapped market potential for new cardiovascular disease treatments.
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https://www.medtechdive.com/news/abbott-fda-approval-triclip-tricuspid-valve-repair/711997/
Abbott nets FDA approval for Triclip | MedTech Dive
The transcatheter tricuspid valve repair device will compete against Edwards Lifesciences’ Evoque system.
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https://www.medtechdive.com/news/Johnson-JJ-FDA-approval-Varipulse-PFA/732277/
J&J wins FDA approval for Varipulse PFA system | MedTech Dive
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https://www.medtechdive.com/news/medtronic-pulsed-field-ablation-FDA-approval/702554/
Medtronic snags first pulsed field ablation approval in US | MedTech Dive
medtronicsnagsfirstpulsedfield