This is the company’s 6th FDA clearance and further solidifies its leadership as the most comprehensive acute AI vendor in the market NEW YORK, Oct. 21, 2020 /PRNewswire/ — Aidoc announced today that the US Food and Drug Administration (FDA) has given regulatory clearance for the commercial use of its triaging and notification algorithms […]
Regulatory
LIVMOR receives FDA clearance for the world’s first prescriptible wearable for continuous heart monitoring
Availability of physician-prescribed cardiac monitoring system will significantly improve screening and treatment of atrial fibrillation and other chronic heart conditions. DALLAS, Oct. 15, 2020 /PRNewswire/ — LIVMOR, Inc., a leading digital health solutions company, announced today that the Company received FDA 510(k) clearance for the LIVMOR Halo™ AF Detection System, a physician-prescribed wearable […]
Bracco Diagnostics Inc. Introduces New CardioGen-82® (Rubidium Rb 82 Generator) Infusion System
MONROE TOWNSHIP, N.J., Oct. 16, 2020 /PRNewswire/ — Bracco Diagnostics Inc., the U.S subsidiary of Bracco Imaging S.p.A., a leading global company in the diagnostic imaging business, announced today the FDA approval of its new CardioGen-82 infusion system to enhance automation, efficiency and simplicity in cardiac position emission tomography (PET) myocardial perfusion imaging (MPI). […]
Nation’s First Implant of Bluetooth-Connected Heart Device at St. Elizabeth
EDGEWOOD, Ky., Oct. 15, 2020 /PRNewswire/ — Dr. Mohamad Sinno recently performed the first implantation in the U.S. of a Bluetooth-enabled biventricular implantable cardiac defibrillator (ICD) at St. Elizabeth Edgewood. The new device, the Abbott Gallant, recently received FDA approval for a new technology assessment and is available in only a few centers in the U.S. […]
GE Healthcare Receives FDA Clearance for Vivid Ultra Edition, AI-Powered Cardiovascular Ultrasound System Designed to Shorten Diagnostic Exam Time and Improve Measurement Consistency
CHICAGO–(BUSINESS WIRE)–GE Healthcare today announced U.S. FDA 510k clearance for its Ultra Edition package on Vivid1 cardiovascular ultrasound systems, which includes new features based on artificial intelligence (AI) that enable clinicians to acquire faster, more repeatable exams consistently. Methodical assessments of heart function are key in echocardiography but can be tedious […]
Biosense Webster Receives FDA Approval for THERMOCOOL SMARTTOUCH® SF Ablation Catheter for the Treatment of Persistent Atrial Fibrillation
The CARTO® 3 System and THERMOCOOL SMARTTOUCH® SF Catheter allow for a patient-tailored ablation approach, resulting in high long-term effectiveness in persistent atrial fibrillation patients* IRVINE, Calif., Oct. 6, 2020 /PRNewswire/ — Johnson & Johnson Medical Devices Companies** today announced the United States Food and Drug Administration (FDA) approval of Biosense Webster, Inc.’s THERMOCOOL […]
Teleflex Announces Expanded Indications for the Arrow® EZ-IO® Intraosseous Vascular Access System
Now Cleared for up to 48-Hour Dwell WAYNE, Pa., Oct. 01, 2020 (GLOBE NEWSWIRE) — Teleflex Incorporated (NYSE: TFX), a leading global provider of medical devices for critical care and surgery, has announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to expand the Indications […]
SentiAR Announces FDA 510K Clearance of CommandEP™ System, the First Holographic Cardiac Ablation Guidance System
ST. LOUIS, Sept. 30, 2020 /PRNewswire/ — SentiAR, a pioneer in visualization technologies for surgical applications announces U.S. Food and Drug Administration (FDA) 510(k) clearance of its groundbreaking CommandEP™ system, the first holographic guidance system to be used during an invasive cardiac procedure. The CommandEP system allows electrophysiologists to visualize 3D electroanatomic models in […]
Medtronic Receives FDA “Breakthrough Device Designation” for TYRX Driveline Wrap Device
DUBLIN, Sept. 22, 2020 /PRNewswire/ — Medtronic plc (NYSE:MDT), the global leader in medical technology, has received Breakthrough Device Designation status from the U.S. Food and Drug Administration (FDA) for the TYRX™ Absorbable Antibacterial Driveline Wrap, which is intended to securely hold a percutaneous driveline in patients receiving a ventricular assist device (VAD). […]
Surmodics Receives FDA 510(k) Clearance for Pounce™ Thrombus Retrieval System
Next-generation technology provides easy, effective clot removal from peripheral arterial vasculature EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (NASDAQ:SRDX), a leading provider of medical device and in vitro diagnostic technologies to the health care industry, announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Pounce™ Thrombus Retrieval System. […]
Recent
Popular
- No commented posts yet