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Aptitude Receives FDA Authorization for Metrix® COVID/Flu Multiplex Molecular Test for Point-of-Care and Over-the-Counter Use

SANTA BARBARA, Calif., Feb. 24, 2025 /PRNewswire/ — Aptitude Medical Systems, Inc. (Aptitude) today announced it has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its next-gen molecular Metrix® COVID/Flu multiplex test. This innovative test represents a major advancement in accessible molecular diagnostics.

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Atreon Orthopedics Announces FDA 510(k) Clearance and Full Market Launch of BioCharge® Autobiologic Matrix for Rotator Cuff Repair

DUBLIN, Ohio, Feb. 20, 2025 /PRNewswire/ — Atreon Orthopedics, LLC, a Columbus based innovator in tissue healing and regenerative technologies, announces the 510(k) clearance from the Food and Drug Administration (FDA) and the full market launch of BioCharge® Autobiologic Matrix, a bioresorbable synthetic implant designed to address biological failure modes in rotator cuff repair while improving repair integrity and long-term patient outcomes.

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CathVision Receives CE Mark for ECGenius System, Advancing Cardiac Monitoring and Analytics Technology in Europe

COPENHAGEN, Denmark, Feb. 19, 2025 /PRNewswire/ — CathVision, a medical technology company developing advanced electrophysiology solutions, is proud to announce that it has received CE Mark for its breakthrough product, ECGenius System. This regulatory milestone allows CathVision to market and distribute ECGenius System across the European Economic Area (EEA), bringing state-of-the-art electrophysiology solutions to healthcare providers and patients.

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Implantica announces Module 1 is accepted and closed by FDA in the PMA application for RefluxStop™

VADUZ, Liechtenstein, Feb. 12, 2025 /PRNewswire/ — Implantica AG (publ.), a medtech company at the forefront of introducing advanced technology into the body, including a unique device RefluxStop™ for the treatment of acid reflux, a treatment field with 1 billion sufferers, is pleased to announce that the FDA has accepted Module 1 of the company’s premarket approval (PMA) application, and that this module is now considered closed.

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Neuvotion Receives FDA Clearance for NeuStim™ Providing Non-Invasive, High-Resolution Stimulation for the Hand After Stroke or Spinal Cord Injury

STAMFORD, Conn., Feb. 11, 2025 /PRNewswire/ — Neuvotion, Inc. is an early-stage medical device company developing AI-driven neuromodulation technologies and products for use in the neurorehabilitation, brain-computer interface (BCI), and physical therapy markets. Neuvotion has received FDA 510(k) clearance for their first product, NeuStim™, a non-invasive, surgery-free wearable that electrically stimulates muscles dynamically and with high-precision.

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