Caristo Diagnostics Completes Series A Financing and Welcomes New CEO to Advance Ground-Breaking AI Technology for Cardiac Disease Detection

Caristo Diagnostics Limited, a global leader in cardiac and vascular disease diagnostics and risk prediction, today announced it has secured a further £13 million (US$16.3 million) to conclude its Series A financing round. Caristo will use the capital to advance its CaRi-Heart® technology, an AI-assisted diagnostics and risk prediction tool, into standards of cardiac care in…

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BioVentrix® Closes $48.5 Million Series A Financing

BioVentrix, Inc., a privately held medical device company developing minimally invasive therapies to directly treat the dilated left ventricle and reverse the left ventricular remodeling process in patients with congestive heart failure, today announced the completion of $48.5 million Series A round financing. The round was led by Andera Partners, a prominent life-science venture capital investor. The…

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Icentia Receives U.S. Food and Drug Administration (FDA) Clearance for CardioSTAT®

Icentia Inc., 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 medical device market. With the cost effectiveness and demonstrated ability of…

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Positive Results From PROMISE II Pivotal Trial Showing that LimFlow System Saves Most Patients with End-stage Peripheral Artery Disease From Major Amputation

LimFlow SA, a pioneer in the development of minimally-invasive technology for the treatment of chronic limb-threatening ischemia (CLTI), a severe form of peripheral artery disease (PAD), announced today that results from the PROMISE II U.S. pivotal trial were published in today’s issue of the New England Journal of Medicine (NEJM). The results demonstrated that the…

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Ancora Heart’s AccuCinch System Demonstrates Significant Improvement in Quality of Life, Cardiac Structure and Function in Heart Failure Patients

Ancora Heart, Inc., a company developing a completely transcatheter device-based therapy to address heart failure (HF), announced that patients treated with the investigational AccuCinch® Ventricular Restoration System demonstrated improvement in HF patient outcomes and beneficial changes in the structure of the heart. The 12-month data were presented as part of a late-breaking clinical science session at…

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HeartBeam Announces Acquisition of LIVMOR Assets

HeartBeam, Inc. (NASDAQ: BEAT), a cardiac technology company that has developed the first and only 3D-vector electrocardiogram (VECG) platform for heart attack detection anytime, anywhere, announced the strategic acquisition of substantially all assets from LIVMOR, a digital health solutions company providing a patient-engaging remote monitoring system of critical physiological biomarkers. The acquisition extends HeartBeam’s reach in…

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Vivasure Medical Announces FDA IDE Approval to Initiate U.S. Pivotal Study

Vivasure Medical® Limited (“Vivasure” or the “Company”), a company pioneering novel fully absorbable technology for percutaneous vessel closure, announced that the U.S. Food and Drug Administration (FDA) has granted an Investigational Device Exemption (IDE) to advance the company’s PATCH Clinical Study, a multi-center, single-arm, pivotal study evaluating the safety and effectiveness of the Vivasure PerQseal® Closure Device…

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Live Remote Cardiac MRI Exam to Showcase Vista.ai’s Automated and Virtual Scan Capabilities at ACC.23/WCC

Vista.ai, a pioneer and leader in automated MRI solutions, today announced that Dr. Michael Salerno, Chief, Cardiovascular Imaging at Stanford Health Care, will conduct a live remote cardiac MRI (CMR) scan using the company’s One Click MRI™ software at the American College of Cardiology’s 72nd Annual Scientific Session Together With World Heart Federation’s World Congress…

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ReCor Medical Announces Two Concurrent JAMA Network Publications of Study Results on the Paradise Ultrasound Renal Denervation System for the Treatment of Hypertension

ReCor Medical, Inc. (“ReCor”) and its parent company, Otsuka Medical Devices Co., Ltd. (“Otsuka Medical Devices”) today announced that primary endpoint results from the RADIANCE II pivotal trial were published in the Journal of the American Medical Association (JAMA). Study results showed that the Paradise Ultrasound Renal Denervation (uRDN) System successfully reduced blood pressure compared to…

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Eko Launches SENSORA™ Cardiac Disease Detection Platform

Eko, a digital health company applying artificial intelligence (AI) in the fight against heart and lung disease, today announced the launch of the SENSORA™ Cardiac Disease Detection Platform. SENSORA™ currently features AI that objectively identifies structural murmurs, a sign of valvular heart disease, and Care Pathway Analytics software that provides downstream visibility and metrics of the…

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