A bracelet that triggers the production of endorphins, without addiction, featuring Remedee
Remedee Labs is now scheduled to conduct a clinical trial, scheduled to begin in the second quarter of 2021, for a period of 12 months. This project is being carried out jointly with the CHU Grenoble Alpes, the Clinatec research center, the National Institute for Health and Medical Research (Inserm) and the company STMicroelectronics. Read More →
Promaxo Receives 510(k) Clearance from the FDA for its Innovational MRI Platform
The United States Food and Drug Administration (FDA) has granted Promaxo, Inc. (Promaxo) a 510(k) clearance for its revolutionary office-based MRI system. The 510(k) clearance enables practices and hospitals to accurately and seamlessly guide prostate interventions under the Promaxo scanner. Read More →
Access Vascular, Inc. Secures $20 Million in Series B Financing
Access Vascular, Inc., a company addressing the most common and costly venous access complications, today announced it has closed on a Series B round of financing. Read More →
Soundbite Medical Wins Health Canada Approval for PAD Treatment
The SCS-P (14P) is intended to treat patients suffering from PAD with heavily calcified above-the-knee (ATK) and below-the-knee (BTK) chronic total occlusions (CTO). Read More →
Vetex Medical Receives FDA Clearance for Revene Thrombectomy Catheter
Vetex Medical Ltd. today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for the ReVene® Thrombectomy Catheter. ReVene uses dual-action technology designed to de-clot peripheral vessels, such as in Deep Vein Thrombosis (DVT), through wall-to-wall contact in a single session without the use of thrombolytics. Read More →
Protembis announces completion of 20 cases in European CE mark study with the ProtEmbo® Cerebral Protection System
Protembis GmbH, a privately held emerging medical device company, announced today the successful completion of 20 clinical cases in its European regulatory study of the ProtEmbo® Cerebral Protection System. The ProtEmbo® System is an intra- aortic filter device that deflects embolic material away from the brain during transcatheter aortic valve replacement (TAVR). Read More →
Redox Raised $45M To Connect Healthcare Data In The Cloud
Redox, which is geared towards software developers and hospital systems, aims to do for healthcare what Plaid did for the financial services industry. Read More →
Forest Devices Announces Positive Study Results for Their Stroke Detection Technology
Medical technology pioneer Forest Devices, Inc. (FDI) today announced the publication of positive results from the EDGAR study of its AlphaStroke™ technology in identifying patients with large vessel occlusive (LVO) strokes in emergency departments in the American Heart Association Journal, STROKE. Read More →
MedAware Systems Launches AI Post Market Surveillance for Neuromodulation Devices
MedAware Systems’ Science of Health Informatics (SOHInfo) announces the launch of its comprehensive AI-powered surveillance service for Spinal Cord and Peripheral Nerve stimulation devices from all major manufacturers. Read More →
HydroMID Midline Catheter from Access Vascular Receives FDA Clearance
Access Vascular, Inc. today announced FDA clearance of its HydroMID™ midline catheter. HydroMID, which is made of Access Vascular’s proprietary biomaterial that has been shown to reduce thrombus accumulation by up to 97 percent when compared to standard polyurethane catheters,1 is the second device in its planned portfolio to obtain clearance. Read More →