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Xeltis announces FDA Breakthrough Device Designation for aXessTM and first patient treated in US pivotal trial

EINDHOVEN, The Netherlands, Nov. 14, 2024 /PRNewswire/ — Xeltis, a leading developer of transformative implants that enable the natural creation of living and long-lasting vessels, today announces that the Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has granted aXess Breakthrough Device Designation status. aXess is Xeltis’ vascular access conduit, which enables the creation of a new, permanent, living vessel for hemodialysis vascular access.

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Eko Health Granted Category III CPT Code for SENSORA™ AI Heart Disease Detection Platform

SAN FRANCISCO, Nov. 14, 2024 /PRNewswire/ — Eko Health, a pioneer in applying artificial intelligence for early detection of heart and lung diseases, today announced the issuance of a Category III Current Procedural Terminology (CPT) code by the American Medical Association (AMA) for its SENSORA™ platform. The newly issued Category III CPT code will be effective on July 1, 2025, and is the first step to coverage and reimbursement for SENSORA™, bringing advanced heart disease detection to clinicians across the U.S.

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

HOFFMAN ESTATES, Ill., Nov. 14, 2024 /PRNewswire/ — In a pivotal stride to address the growing AFib epidemic, OMRON Healthcare today 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 stroke.

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Implantica submits FDA PMA application Clinical Module 2 for RefluxStop™ for U.S. market approval

VADUZ, Liechtenstein, Nov. 14, 2024 /PRNewswire/ — Implantica AG (publ.), a medtech company at the forefront of introducing advanced technology into the body, including the unique device RefluxStop™ for the treatment of acid reflux, a treatment field with 1 billion sufferers, announces the submission of the second clinical module of the Premarket Approval (PMA) application to the US FDA for RefluxStop™ along with responses to the FDA’s findings from the first module.

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