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Imaging Visualization & Navigation

Activ Surgical Announces FDA Clearance for ActivSight Enhanced Surgical Visualization Device

Activ Surgical, a digital surgery pioneer, today announced the U.S. Food and Drug Administration (FDA) 510(k) clearance of the company’s ActivSight Intraoperative Imaging Module for enhanced surgical visualization. The hardware agnostic imaging module has been designed to provide surgeons real-time intraoperative...

April 11, 2021

Diagnostics & Healthcare News

Donisi Wins De Novo Clearance for Contact-Free AI System that Spots Changes in Heart, Breathing Patterns

The U.S. Food and Drug Administration (FDA) has granted Donisi‘s revolutionary contact-free multiparameter measurement system de novo clearance, making Donisi the first to bring this innovative technology to the medical market. “I’m really proud of our team; we developed a medical device that...

April 11, 2021

Cardiovascular / Cardiology

Rapid Medical Receives FDA Clearance for the First Adjustable Stent Retriever for Use in Ischemic Stroke Treatment

Rapid Medical, developer of responsive, adjustable neurovascular devices, announces the FDA clearance of its TIGERTRIEVER™ revascularization device for use in the treatment of ischemic stroke. TIGERTRIEVER is the first stent retriever to offer intelligent control, enabling neuro interventionalists to better remove blood...

March 28, 2021

Orthopedics and Spine

SeaSpine Acquiring 7D Surgical for $110M

SeaSpine Holdings Corporation (NASDAQ: SPNE), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, announced today that it has entered into an agreement to acquire all of the issued and outstanding shares of 7D Surgical, Inc.,...

March 28, 2021

Orthopedics and Spine

Catalyst OrthoScience Receives FDA 510(k) Clearance of Its Reverse Shoulder System

Catalyst OrthoScience Inc. (Catalyst), a medical device company focused on the upper extremity orthopedics market, has received clearance from the U.S. Food & Drug Administration (FDA) to market its reverse shoulder system. Catalyst expects to begin a limited user release in...

March 21, 2021

Cardiovascular / Cardiology

Qardio Lands 510(k) for Ambulatory ECG Device

Qardio, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted the company 510k clearance for its QardioCore ambulatory ECG device.  QardioCore will initially be marketed for holter monitoring applications, for use with QardioMD, Qardio’s cloud-based remote patient monitoring solution....

March 21, 2021

Cardiovascular / Cardiology

Imbio Receives FDA 510(k) Clearance for New Cardiothoracic Imaging Algorithm

Imbio, a leading provider of artificial intelligence (AI) solutions for medical imaging analysis, has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its RV/LV Analysis™ algorithm. The RV/LV Analysis algorithm is a rapid, automated assessment of potential right ventricular dilation. The...

March 21, 2021

Imaging Visualization & Navigation

Quibim Receives FDA 510(k) Clearance for qp-Prostate AI Solution for Prostate MRI Analysis

Quibim, a global leader in whole-body medical imaging analysis, announced today the launch of qp-Prostate, its latest and most advanced prostate AI based Magnetic Resonance (MR) solution, after receiving 510(k) clearance by the US Food and Drug Administration. The solution aids...

March 14, 2021

Surgery and Surgical Robotics

Preceptis Medical Announces Publication of Positive Results from Pediatric In-Office Study of the Hummingbird Tympanostomy Tube System (TTS)

Preceptis Medical, Inc., a company dedicated to helping ENT surgeons improve how they care for children, today announced positive results from a prospective, multicenter study designed to assess in-office pediatric ear tube placement with the FDA-cleared Hummingbird Tympanostomy Tube System...

March 14, 2021