This section presents the latest developments, inventions, and revolutionary technologies that change the face of healthcare.
Alleviant Medical Gains FDA Breakthrough Designation for Heart Failure Technology Alleviant Medical, Inc., a private medical device company specialising in no-implant atrial shunt technology for heart failure, has announced two significant developments from the US Food and Drug Administration (FDA). ...
Simpson Interventions has reached significant development milestones in the field of cardiovascular interventional devices. The company’s innovative Acolyte™ Image-Guided Crossing and Re-Entry Catheter System has been granted an Investigational Device Exemption (IDE) by the U.S. Food and Drug Administration (FDA). ...
Zephyrus Innovations, a privately owned medical device company specialising in the design and manufacture of safety syringes and Closed System Transfer Devices (CSTDs), has introduced its latest product, VaporShield....
ONWARD Medical has announced that its ARC-EX System has received de novo classification and marketing authorisation from the US Food and Drug Administration (FDA)....
SeaStar Medical has announced the receipt of Breakthrough Device Designation from the US Food and Drug Administration (FDA). This recognition was granted by the FDA’s Center for Biologics...
IntelliSense™ AFib algorithm uses machine learning to analyse the Pressure Pulse Wave generated during routine blood pressure measurements. This breakthrough incorporates...
This device is designed to measure pressure and dimensions in the esophagus and pylorus in adults, helping to diagnose esophageal motility disorders. The Endoflip™ system can be used during the first endoscopy...
Ultromics' EchoGo® Amyloidosis is an AI-based tool designed for echocardiography. This milestone makes it the first device enrolled in the FDA's Total Product Lifecycle Advisory Program...
BrightHeart has received FDA 510(k) clearance for its first artificial intelligence software. This software is designed to enhance the assessment of fetal heart health during prenatal ultrasounds...
Exactech has announced the successful first surgical procedures using its new Equinoxe® Central Screw (CS) Baseplate implant. This development represents a significant advancement...
