Posts by rw-admin
ZOLL Medical Corporation Acquires Respicardia
ZOLL Medical Corporation, an Asahi Kasei company that manufactures medical devices and related software solutions, today announced that it has acquired Respicardia, Inc., a provider of novel implantable neurostimulators for the treatment of moderate to severe Central Sleep Apnea (CSA). CSA is a serious condition that is often associated with heart failure, coronary artery disease,…
Read MoreActiv 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 visual data and imaging not currently available to surgeons through existing technologies, helping to improve…
Read MoreDonisi 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 can change the lives of millions of people. Our novel technology is now recognized and…
Read MoreRapid 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 clots and restore blood flow the brain following an ischemic event—a condition that devastates 800,000…
Read MoreSeaSpine 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., a privately-held, Toronto-based company, in a cash and stock deal valued at $110 million, subject to customary…
Read MoreCatalyst 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 the United States in the second quarter of 2021 followed by a commercial launch later…
Read MoreQardio 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. QardioCore extends Qardio’s remote patient monitoring platform from primary care and hypertension monitoring to acute…
Read MoreImbio 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 tool quickly and accurately measures the ventricles of the heart to provide the ratio of…
Read MoreQuibim 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 in the process of prostate magnetic resonance imaging (MRI) reporting from visualization to quantification with…
Read MorePreceptis 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 (TTS). Peer-reviewed results from the study were published in Laryngoscope Investigative Otolaryngology. Outcomes from the study…
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