Regulatory Approvals

Imeka Receives FDA 510(k) Clearance for ANDI Medical Device

Advanced Neuro Diagnostic Imaging (ANDI) software extracts features from medical images to map and analyze microstructural properties of white matter Provides adjunctive information for use...

UltraSight receives FDA approval for AI-based cardiac ultrasound technology

UltraSight receives FDA approval for AI-based cardiac ultrasound technology. UltraSight has secured approval from the US Food and Drug Administration (FDA) for its artificial intelligence (AI)-based cardiac...

Microbot Medical Announces First Steps to Advance CE Mark for Sales in Europe 

Microbot Medical Inc. has announced the first steps towards its planned European market clearance, by engaging with a leading Notified Body. The Notified Body will audit...

Imperative Care Announces FDA Clearance of Zoom 88 Support, Designed to Bring the Benefits of Intracranial Access to More Stroke Patients

Imperative Care, a medical technology company developing connected innovations to elevate care for people affected by stroke and other ischemic diseases, announced U.S. Food...

Inspira™ Technologies Receives Certification of Medical Devices Quality Management Systems, Another Step Towards EU Regulatory Approval

Inspira™ Technologies OXY B.H.N. Ltd. (Nasdaq: IINN, IINNW) (the "Company" or "Inspira Technologies"), a company aiming to revolutionize acute respiratory care, is proud to announce it...

STORZ & BICKEL Announces Certification of Medical Vaporizers Under New EU Medical Device Regulations

Certification reinforces STORZ & BICKEL's leadership position in medical device design, ensures continued availability of devices worldwide STORZ & BICKEL GmbH ("STORZ & BICKEL"), the...

FDA Clears ReddyPort® Non-Invasive Ventilation Device

ReddyPort announced today that the US Food and Drug Administration (FDA) granted 510(k) premarket clearance for the ReddyPort elbow device used in non-invasive ventilation...

MediView XR receives 510(k) clearance for AR surgical navigation platform

The Ohio-based company's XR90 offering allows physicians to view a patient's anatomical structures in 3D for preoperative and intraoperative use. MediView XR, a medtech company...

Spark Biomedical’s second-generation device, Sparrow® Ascent, Receives FDA Clearance for Opioid Withdrawal Relief in Adults

This FDA-cleared wearable neuromodulation system offers game-changing access for patients to start the road to recovery without interruptions to daily living. Spark Biomedical, Inc., a...
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