Author: Ken Dropiewski

ENDRA Life Sciences Submits De Novo Request for its TAEUS® System Liver Fat Application to the U.S. FDA

ANN ARBOR, Mich.–(BUSINESS WIRE)–ENDRA Life Sciences Inc. (NASDAQ: NDRA), a pioneer of imaging technologies and Thermo Acoustic Enhanced UltraSound (TAEUS®), announces the submission of a De Novo request to the U.S. Food and Drug Administration (FDA) for the TAEUS system. The TAEUS system is ENDRA’s proprietary device that is intended to […]

DiaMedica Therapeutics Provides a Business Update and Announces Second Quarter 2023 Financial Results

MINNEAPOLIS–(BUSINESS WIRE)–DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for neurological disorders and cardio-renal disease, today provided a business update and financial results for the quarter ended June 30, 2023. Management will host a conference call Tuesday, August 15, 2023, at 7:00AM Central Time/8:00AM […]

Viz.ai Receives First De Novo Approval by the FDA for Hypertrophic Cardiomyopathy AI Algorithm

SAN FRANCISCO–(BUSINESS WIRE)–Viz.ai, the leader in AI-powered disease detection and intelligent care coordination, today announced it has received a De Novo approval by the U.S. Food and Drug Administration (FDA) for its Viz HCM module, a hypertrophic cardiomyopathy (HCM) artificial intelligence (AI) detection algorithm, creating a new regulatory category for […]

HDL Therapeutics to Go Public in Merger with Swiftmerge Acquisition Corp.

NEW YORK & VERO BEACH, Fla.–(BUSINESS WIRE)–HDL Therapeutics, Inc. (“HDL Therapeutics”), a privately held commercial stage biotech company with an FDA-approved cardiovascular therapy the Plasma Delipidation System (PDS-2™ System) for reducing coronary atheroma in patients with homozygous familial hypercholesterolemia (HoFH), has signed a definitive merger agreement with Swiftmerge Acquisition Corp. […]

Xeltis secures additional €12.5 million from European Innovation Council Fund in final close of D2 financing

EINDHOVEN, The Netherlands – 14 August 2023, Xeltis a leading developer of transformative implants that enable the natural creation of living and long-lasting vessels today announces the closing of an additional €12.5 million in funding from the European Innovation Council (EIC) Fund, set up by the European Commission. Today’s extension […]

Humacyte Second Quarter 2023 Financial Results and Business Update

DURHAM, N.C., Aug. 14, 2023 (GLOBE NEWSWIRE) — Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announced financial results for the second quarter ended June 30, 2023, and highlighted recent corporate accomplishments. “Humacyte has made significant strides in the […]

ConcertAI’s TeraRecon Partners with GLEAMER to Advance Clinical AI Capabilities on the Eureka Clinical AI Platform

CAMBRIDGE, Mass., Aug. 14, 2023 /PRNewswire/ — Advanced visualization and AI leader TeraRecon, a ConcertAI company, is proud to announce its strategic partnership with GLEAMER, a leading provider of AI solutions for medical imaging. By joining forces, the two companies aim to advance the field of radiology by integrating GLEAMER’s BoneView and […]

CytoSorbents Completes U.S. and Canadian STAR-T Pivotal Trial

PRINCETON, N.J., Aug. 14, 2023 /PRNewswire/ — CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in intensive care and cardiac surgery using blood purification via its proprietary polymer adsorption technology, announced that it has completed the pivotal STAR-T (Safe and Timely Antithrombotic Removal – Ticagrelor) randomized, controlled trial, following the last scheduled patient follow-up.  The […]

DurAVR™ THV Demonstrates Exceptional Results in Second Valve-in-Valve Case

BRISBANE, Australia & MINNEAPOLIS–(BUSINESS WIRE)– Anteris Technologies Ltd (Anteris or the Company) (ASX: AVR, OTC: ANTTY) reported today that DurAVR™ THV, a new class of biomimetic heart valve and the world’s only balloon-expandable, single-piece transcatheter aortic valve was implanted in a second successful Valve-in-Valve (ViV) procedure as part of Health Canada’s Special […]