Surgical
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Cardiovascular | Surgical
CMS Updates National TAVR Coverage
Decision expands access to TAVR by modernizing requirements providers must meet to perform the cardiac procedure under Coverage with Evidence Development (CED).Centers for Medicare & Medicaid Services 06.24.19
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Surgical
Teleflex Recalls Endotracheal Tubes Over Risk of Connector Disconnecting from Breathing Circuit
Teleflex Medical has received 179 complaints with 192 occurrences in association with the ETT disconnection.U.S. Food and Drug Administration 06.21.19
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Contract Manufacturing | Materials | Surgical
Bentec Medical Appoints New CEO
JG Singh most recently worked at Gold Standard Diagnostics as part of the Eurofins group.06.20.19
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Cardiovascular | Surgical
Cook Recalls PTA Balloon Catheters Due to Balloons Bursting
Multiple complaints were received for balloons in Cook's Advance Enforcer 35 Focal Force PTA Balloon Catheter bursting below the rated burst pressure.U.S. Food and Drug Administration 06.19.19
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Electronics | Software & IT | Surgical
FDA OKs MRI-Safe Cochlear Implant with Android Connectivity
Cochlear delivers Nucleus Profile Plus Implant, first cochlear implant manufacturer to enable Android direct connectivity with the Nucleus 7 Sound Processor.PR Newswire 06.17.19
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Surgical
Merit Medical Acquires Brightwater Medical for Up to $50M
Brightwater's ConvertX is a single device used to replace a series of devices and procedures used to treat severe obstructions of the ureter.GlobeNewswire 06.17.19
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Surgical
FDA Approves Apollo Endosurgery's ORBERA Balloon Label Update
The labeling updates improve patient safety by providing further definition and guidance on appropriate use.Business Wire 06.14.19
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Cardiovascular | Software & IT | Surgical
FDA OKs Materialise's Cardiovascular Planning Software Suite
Introductory Workflow, Mimics Enlight Mitral provides support for transcatheter mitral valve replacements (TMVR).Business Wire 06.14.19
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Surgical
Canady Life Sciences Acquires Endocontrol & Its Voice-Operated Robotic Tech
Endocontrol designs, manufactures, and markets robotic-assisted solutions for mini-invasive and laparoscopic surgery.Business Wire 06.13.19
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Surgical
Microsure’s MUSA Microsurgery Robot Receives CE Mark
MUSA is the world’s first surgical robot for open microsurgery.Business Wire 06.07.19
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Cardiovascular | Surgical
FDA Approves Gore's CARDIOFORM ASD Occluder to Treat Atrial Septal Defects
Data from the Gore ASSURED Clinical Study demonstrated 100 percent closure success at six months.PR Newswire 06.04.19
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Electronics | Surgical
Sense of Touch with FUTEK at BIOMEDevice Boston
Ehsan Mokhberi of FUTEK explains how sensing technologies are enhancing the feel of medical devices for physicians and surgeons.Videos Sean Fenske, Editor-in-Chief
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Contract Manufacturing | Surgical
Teleflex Medical OEM Opens Centers to Accelerate Device Innovation
The two, state-of-the-art EPIC Medtec Centers are located in Mansfield, Mass. and Maple Grove, Minn.Teleflex Medical OEM 06.03.19
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Surgical
FDA OKs Misonix's Integrated Ultrasonic Surgical Platform
Misonix will commence the commercialization of the Nexus platform in the United States in July.GlobeNewswire 06.03.19
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Cardiovascular | Surgical
Terumo Recalls Two Sheaths Over Dislodgment Risk
The company has acknowledged a potential for the tip to dislodge from the outer rim of the sheath.U.S. Food and Drug Administration 05.30.19
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Contract Manufacturing | Digital Health | Software & IT | Surgical
6 Trends Reshaping Medical Equipment Manufacturing
Medical device manufacturers and end users alike must keep an eye on current industry trends in order to prepare and adapt.Online Exclusives Megan Ray Nichols, Science Writer; Editor, Schooled By Science 05.30.19
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Cardiovascular | Surgical
Medtronic's New Catheter System for HIS Bundle Pacing Wins FDA Nod
Pacing at the bundle of HIS is a promising procedure with a growing body of clinical evidence.GlobeNewswire 05.30.19
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3D/Additive Manufacturing | Surgical
3D Printed Artificial Corneas Prove Similar to Human Ones
A research team replicated human corneal structure and fabricated a transparent cornea with the lattice pattern.Pohang University of Science & Technology (POSTECH) 05.29.19
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Cardiovascular | Surgical
FDA OKs Shape Memory Medical's IMPEDE FX Embolization Plug
The IMPEDE-FX Embolization Plug received CE marking in 2018 and has been used to treat patients in several EU countries.Business Wire 05.28.19
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Surgical
Two Charged in Scheme to Defraud Women in Connection with Transvaginal Mesh Litigation
Women around the country were allegedly enticed into agreeing to undergo removal surgeries based on fraudulent information.U.S. Department of Justice 05.28.19
