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OMRON blood pressure monitors

FDA Grants De Novo Authorization to OMRON Healthcare for New Blood Pressure Monitors with AI-Powered AFib Detection Feature

In a pivotal stride to address the growing AFib epidemic, OMRON Healthcare announced the U.S. Food and Drug Administration (FDA) has granted the company its De Novo authorization to market new home blood pressure monitors featuring breakthrough AI-powered atrial fibrillation detection. In a medical device first, OMRON's novel machine learning IntelliSense™ AFib algorithm automatically analyzes the Pressure Pulse Wave generated during blood pressure measurement to detect AFib, a leading cause of stroke1.

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Shockwave Javelin Peripheral IVL Catheter

Shockwave Medical reveals initial clinical outcomes for its new IVL platform

Shockwave Medical, Inc., part of Johnson & Johnson MedTech and a global leader in the field of circulatory restoration, announced the first clinical outcomes associated with the Shockwave Javelin Peripheral IVL Catheter, a novel, non-balloon-based lithotripsy platform designed to modify calcium and cross extremely narrowed vessels in patients with peripheral artery disease (PAD).

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Affera™ Mapping and Ablation System

Medtronic gains FDA approval for its Affera™ Mapping and Ablation System with the Sphere-9™ Catheter, marking a breakthrough in electrophysiology

Medtronic plc  a global leader in healthcare technology, announced United States Food and Drug Administration (FDA) approval of the Affera™ Mapping and Ablation System with Sphere-9™ Catheter, an all-in-one, high-density (HD) mapping and pulsed field (PF) and radiofrequency (RF) ablation catheter for treatment of persistent atrial fibrillation (AFib) and for RF ablation of cavotricuspid isthmus (CTI) dependent atrial flutter.

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Quantra Hemostasis System with QStat Cartridge.

HemoSonics wins NIH prize to expand Quantra Hemostasis System for preventing maternal deaths

HemoSonics, LLC, a medical device company focused on acute bleeding management, announced it has been awarded one of the $525,000 grand prizes in the National Institutes of Health (NIH) RADx Tech for Maternal Health Challenge. NIH's RADx Tech for Maternal Health Challenge sought to accelerate the development of innovative diagnostic tools and solutions to address the maternal mortality crisis.

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MICOR® 700 from ZEISS

ZEISS has introduced a groundbreaking hand-held, ultrasound-free lens removal device, revolutionizing lens extraction technology in the U.S

ZEISS Medical Technology announced the broad U.S. distribution of the MICOR® 700 from ZEISS, reinventing lens extraction with the first hand-held lens removal device with ultrasound-free operation, providing a sustainable solution with a low initial investment to help surgeons broaden their intraocular working space.

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prodisc C Vivo & prodisc C SK

Centinel Spine's prodisc® C Vivo and prodisc C SK Cervical Total Disc Replacement System surpass 7,500 procedures in just two years.

Centinel Spine®, LLC the leading global medical device company focused exclusively on treating cervical and lumbar spinal disease with the most complete and clinically-proven total disc replacement (TDR) technology platform in the world (prodisc®),  announced the completion of 7,500 U.S. cases with the prodisc C Vivo and prodisc C SK Cervical TDR System since the limited commercial launch two years ago, in September 2022.

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