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/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/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...
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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/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/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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