Cardiac Surgery
Cardiac Surgery
Cardiac Surgery
Early Bird, an Internal Bleeding Detector, Now Available In U.S.
Saranas, a Houston, Texas firm, is releasing its novel Early Bird bleeding monitoring system in the United States, following FDA de novo approval of the device. Intended for use during minimally invasive vascular procedures, the Early Bird...
Cardiac Surgery
Material to Repair Cardiac Tissue Damaged by Heart Attacks Passes First Clinical Trial
Ventrix, a spin-off company of the University of California San Diego, has developed a special hydrogel that can be injected into the heart to provide a platform for cardiac repair following a heart attack. The technology was just tested in...
Cardiac Surgery
FDA Clears Siemens Artis icono Angiography Systems
Siemens Healthineers won FDA clearance for the ARTIS icono angiography systems that are designed for use in a variety of procedure types. The ARTIS icono 2D/3D biplane system is intended for neuroradiology and abdominal imaging while the ARTIS...
Cardiac Surgery
Injectable Hydrogel for Transcatheter Intravascular Embolization: Interview with Dr. Rahmi Oklu, Founder of Obsidio
Obsidio Inc., a medical device company based in Columbia, South Carolina, has developed an embolic hydrogel (called a gel embolic material: GEM) designed to be delivered minimally invasively through a clinical catheter for blood vessel occlusion....
Cardiac Surgery
Tivus Ultrasound System for Pulmonary Arterial Hypertension Gets FDA Breakthrough Designation
SoniVie, a company based in Israel, won FDA Breakthrough Device Designation for its TIVUS intravascular ultrasound system for patients suffering from pulmonary arterial hypertension (PAH). Currently there are only medications available for PAH...
Cardiac Surgery
Nanovolcanoes Record Electrical Activity Inside Heart Cells
The electrical activity of cardiomyocytes and other excitable cells such as neurons is studied using a number of techniques. To get details about the action potentials within the interior of the cell requires either forcefully pushing...
Cardiac Surgery
Edwards ForeSight Brain Oxygenation Sensors FDA Cleared to Pair with HemoSphere Monitor
Edwards Lifesciences won FDA clearance to integrate its ForeSight brain tissue oximetry sensors with the HemoSphere monitoring platform. While the clearance is really for a connecting cable, the capability allows anesthesiologists to monitor...
Cardiac Surgery
Barostim Neo Neuromodulation Device for Heart Failure Wins FDA Approval
CVRx, a Minneapolis, Minnesota company, won FDA approval for the first neuromodulation device designed to address heart failure. Intended as a treatment option for patients with an ejection fraction ≤35% and New York Heart Failure...
Cardiac Surgery
Nexus Ultrasonic Surgical Platform from Misonix Cleared in Europe
Mixonix, a Farmingdale, New York company that focuses on ultrasonic devices for surgical applications, including osteotomies and debridements, landed European CE Mark approval for its Nexus surgical platform. The system was FDA cleared earlier...
Cardiac Surgery
