Category: CERTIFICATIONS - Page 66 - Start Medical Product Development

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

February 19, 2025

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.

Boston Scientific wins CE mark for Farapulse Nav mapping tech

February 17, 2025

Boston Scientific (NYSE: BSX)+
announced today that it received CE mark for its navigation-enabled Farawave Nav ablation catheter and Faraview software.

Navi Medical Technologies’ Neonav® ECG Tip Location System Receives FDA 510(k) Clearance

February 16, 2025

MELBOURNE, Australia, Feb. 16, 2025 /PRNewswire/ — Navi Medical Technologies, a medical device company focused on pediatric healthcare innovation, proudly announces that its Neonav® ECG Tip Location System has received 510(k) clearance from the U.S. Food and Drug Administration (FDA).

CE Mark Approval for RemeOs™ Trauma Screw Product Group, featuring four product lines with over 200 individual products, drives global expansion for Bioretec

February 14, 2025

TAMPERE, Finland, Feb. 14, 2025 /PRNewswire/ — Bioretec Ltd., a pioneer in absorbable orthopedic implants, has achieved a pivotal milestone with the successful completion of its CE mark approval process for the RemeOs™ Trauma Screw product portfolio

Subtle Medical’s SubtleHD™ Awarded FDA Clearance, Setting a New Benchmark for MRI Image Quality and Speed

February 13, 2025

With FDA clearance of SubtleHD™, Subtle Medical launches Subtle-ELITE™, an industry-first AI package designed to achieve superior image quality, unprecedented speed, and workflow automation

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

February 12, 2025

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.

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

February 11, 2025

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.

InnoVoyce Achieves ISO 13485 Certification, Announces Nationwide Availability of VYLO™ Blue Light Laser System

February 11, 2025

BOSTON, Feb. 11, 2025 /PRNewswire/ — InnoVoyce, a leading medical technology company, proudly announces its ISO 13485:2016 certification, underscoring its dedication to excellence in the design, manufacturing, installation, and servicing of lasers and fiber devices. Alongside this milestone, the company is thrilled to share that its FDA-cleared VYLO™ 455nm Blue Light Laser System is now available nationwide, offering healthcare professionals an advanced tool for treating laryngeal disorders and a wide range of surgical applications.

Newronika wins FDA IDE for adaptive deep brain stim tech

February 8, 2025

Newronika announced today that it received FDA investigational device exemption (IDE) for its deep brain stimulation (DBS) system.

Huxley Medical Announces FDA Clearance for Cellular-Enabled SANSA Home Sleep Apnea Test

February 5, 2025

ATLANTA, Feb. 5, 2025 /PRNewswire/ — Huxley Medical, a commercial-stage medical technology firm focused on streamlining detection of sleep and heart disorders, announced that the US Food and Drug Administration (FDA) has cleared the SANSA home sleep apnea test to begin using cellular data upload capabilities. This breakthrough eliminates the need for Bluetooth pairing or smartphone apps commonly required to transmit test data to physicians, addressing a common source of failed home testing, while simplifying the diagnostic process for patients and providers alike.

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