The Latest Cardiac and Vascular News
The world’s first, customizable vascular biometric monitor has received regulatory clearance to provide medical grade arterial heart health metrics to patients and clinicians IRVINE, Calif., April 26, 2023 /PRNewswire/ — CardieX Limited (ASX: CDX) (CardieX, the Company), today announced its new arterial health monitor, the CONNEQT Pulse (Pulse), has received 510(k) clearance from the […]
OXFORD, England, April 26, 2023 /PRNewswire/ — Ultromics, a leader in the field of artificial intelligence-powered diagnostics for heart failure, has been granted FDA Breakthrough Device Status for its AI-enhanced platform for detecting cardiac amyloidosis. The platform, EchoGo Amyloidosis, uses artificial intelligence to analyse echocardiograms and detect the presence of cardiac amyloidosis, a […]
Abbott’s CentriMag™ Blood Pump, previously cleared for use up to six hours, now can be used to provide longer-term life support to critically ill patients, providing doctors more time to make critical care decisions Abbott’s CentriMag™ Pre-connected Pack, which combines a blood pump and oxygenator to form a life support […]
The FreeClimb 70 Reperfusion System, powered by the Tenzing 7 delivery catheter, enables neurointerventionalists to address critical unmet needs in ischemic stroke treatment SAN MATEO, Calif., April 24, 2023 (GLOBE NEWSWIRE) — Route 92 Medical, Inc., a privately held medical technology company dedicated to improving outcomes for patients undergoing neurovascular […]
Lava® LES is the first liquid embolic product approved by the FDA for use in the peripheral vasculature HAYWARD, Calif., April 18, 2023 /PRNewswire/ — Bay Area-based BlackSwan Vascular, Inc., a privately held company that is developing innovative therapies in endovascular embolization, is pleased to announce it has received FDA Premarket Approval […]
Part of RapidAI’s industry-leading stroke solution, Rapid NCCT Stroke supports faster treatment and transfer decisions while driving greater equity of care SAN MATEO, Calif.–(BUSINESS WIRE)–RapidAI, the global leader in neurovascular and vascular AI-enhanced clinical decision support and patient workflow, today announced it has received FDA 510(k) clearance for Rapid NCCT […]
Designation represents progress for patients with suspected Coronary Microvascular Dysfunction as the FDA recognizes disease’s debilitating impacts and the lack of effective non-invasive options for efficient diagnosis MASON, Ohio–(BUSINESS WIRE)–Genetesis, Inc., the leader in biomagnetic cardiac imaging solutions, today announced that the U.S. Food and Drug Administration (FDA) has granted […]
HOUSTON–(BUSINESS WIRE)–IPS HEART has been granted rare pediatric drug designation by the FDA for GIVI-MPC, a first-in-class stem cell therapeutic to create new skeletal muscle with 100% full length dystrophin and for ISX9-CPC, a first-in-class stem cell therapeutic for creating new functional cardiac muscle for the treatment of patients with Duchenne […]
QUEBEC CITY, April 6, 2023 /PRNewswire/ — Icentia Inc., today announced that it has received FDA 510(k) clearance for CardioSTAT, an ambulatory, continuous ECG monitoring solution that relies on a wire free, single-use recorder. “This approval marks a key milestone for our company. The FDA clearance opens the door to the world’s largest […]
Announces Receipt of Positive Formal FDA Feedback via the Q-Submission Program Substantially reduces the anticipated time and cost needed to receive a PMA 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, today announced that it has […]
