Other News

MedAlliance announces the completion of enrollment in SAVE Trial with SELUTION SLR for Treatment of AV Fistulas in Renal Dialysis Patients

GENEVA, Aug. 15, 2023 /PRNewswire/ —  MedAlliance has announced completion of patient enrollment in the  SAVE Clinical Trial with the SELUTION SLR™ 018 DEB (drug-eluting balloon) for the treatment of failed AVF (arteriovenous fistulas) in renal dialysis patients. SELUTION SLR is a novel sirolimus-eluting balloon that provides a controlled sustained release of […]

Clario and AliveCor collaborate to offer advanced, trial-focused six-lead ECG solutions for monitoring in decentralized clinical trials

PHILADELPHIA, Aug. 15, 2023 /PRNewswire/ — Clario, a healthcare research technology company that delivers leading endpoint technology solutions for clinical trials, today announced an expansion to its collaboration with AliveCor, the global leader in FDA-cleared personal electrocardiogram (ECG) technology. This collaboration will enable trial participants to collect medical-grade six-lead ECG readings in the comfort […]

CathVision Secures FDA Clearance of First & Only EP Recording System with AI Algorithm to Measure Success of Cardiac Ablation

COPENHAGEN, Denmark, Aug. 15, 2023 /PRNewswire/ — CathVision, a medical technology company developing innovative electrophysiology solutions designed to enhance clinical decision making in the EP lab, today announced the FDA clearance and commercial availability of the PVI AnalyzerTM and Signal ComplexityTM algorithms. These algorithms are part of the CARDIALYTICSTM suite of artificial intelligence-powered analytics integrated into […]

Hyperfine, Inc. Reports Second Quarter 2023 Financial Results

GUILFORD, Conn., Aug. 14, 2023 (GLOBE NEWSWIRE) — Hyperfine, Inc. (Nasdaq: HYPR), the groundbreaking medical device company that created the Swoop® system, the world’s first FDA-cleared portable, point-of-care MRI system, today announced second quarter 2023 financial results and provided a business update. “We made solid progress at Hyperfine in the […]

Aziyo Biologics Reports Second Quarter 2023 Financial Results – Transformation Continues to Drug-Eluting Biomatrix Company

SILVER SPRING, Md., Aug. 14, 2023 (GLOBE NEWSWIRE) — Aziyo Biologics, Inc. (Nasdaq: AZYO) (“Aziyo”), a company that develops and commercializes biologic products to improve compatibility between medical devices and the patients who need them, today provided a business update and reported financial results for the second quarter ended June […]

LianBio Reports Second Quarter 2023 Financial Results and Provides Corporate Update

SHANGHAI, China and PRINCETON, N.J., Aug. 14, 2023 (GLOBE NEWSWIRE) — LianBio (Nasdaq: LIAN), a biotechnology company dedicated to bringing innovative medicines to patients in China and other major Asian markets, today reported financial results for the second quarter ended June 30, 2023. “During the first half of 2023, we achieved […]

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. […]