Author: Ken Dropiewski

CardieX Receives FDA 510(K) Clearance for a World-First Vascular Biometric Monitor – the CONNEQT Pulse

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 […]

Ultromics granted FDA Breakthrough Device Designation for AI-enhanced Cardiac Amyloidosis detection

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 […]

Capital Health Now Offers Minimally Invasive Aortic Valve Replacement

HOPEWELL, N.J., April 26, 2023 /PRNewswire/ — As part of the growing full-service cardiac program available at Capital Health’s Heart and Vascular Institute, physicians and staff from the Institute’s Structural Heart Program recently performed their first transcatheter aortic valve replacement (TAVR) procedure at Capital Health Regional Medical Center in Trenton, New Jersey. TAVR […]

Boston Scientific Announces Results for First Quarter 2023

MARLBOROUGH, Mass., April 26, 2023 /PRNewswire/ — Boston Scientific Corporation (NYSE: BSX) generated net sales of $3.389 billion during the first quarter of 2023, growing 12.0 percent on a reported basis, 14.9 percent on an operational1 basis and 14.0 percent on an organic2 basis, all compared to the prior year period. The company reported GAAP net income […]

LianBio Announces Positive Topline Results from Phase 3 EXPLORER-CN Trial Evaluating Mavacamten in Chinese Patients

• Mavacamten met the primary endpoint for the treatment of Chinese patients with symptomatic obstructive hypertrophic cardiomyopathy • Mavacamten demonstrated a safety profile consistent with previous studies • If approved, mavacamten is expected to be the first cardiac myosin inhibitor approved in China for the treatment of oHCM • LianBio to host a […]

Surmodics Reports Second Quarter of Fiscal Year 2023 Financial Results; Updates Fiscal Year 2023 Financial Guidance

EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (Nasdaq: SRDX), a leading provider of medical device and in vitro diagnostic technologies to the healthcare industry, today reported financial results for its second quarter ended March 31, 2023, and updated its financial guidance for its fiscal year ending September 30, 2023. Second Quarter Fiscal […]

Vektor Medical Welcomes Two New Advisors to Advance Technology and Commercial Development

SAN DIEGO–(BUSINESS WIRE)–Vektor Medical, developer of the vMap® next-generation arrhythmia mapping technology, today announced former Philips and Biotronik medical technology leader Marlou Janssen and Yale Clinical Professor of Medicine and past American College of Cardiology (ACC) Connecticut Chapter Governor and President Dr. Craig McPherson have joined Vektor’s advisory board. With […]

Juniper Research Awards Cardio Diagnostics Holdings, Inc Future Digital Award for Best Digital Diagnostics Solution

List recognizes most innovative and impactful digital health solutions that have the potential to make a significant impact in the future. CHICAGO–(BUSINESS WIRE)–Cardio Diagnostics Holdings, Inc (Nasdaq: CDIO), a precision cardiovascular medicine company, today announced its PrecisionCHD™ test received Juniper Research’s Future Digital Award for the “Best Digital Diagnostics Solution.” Juniper Research’s Future […]

egnite Announces Portfolio Expansion to Reduce Stroke Risk in Atrial Fibrillation Patients

Expansion leverages a custom module to help health systems identify patients eligible for lifesaving therapy ALISO VIEJO, Calif.–(BUSINESS WIRE)–egnite, Inc., a leading digital health company for cardiovascular care, announces the expansion of its portfolio with the integration of a custom module designed to help physicians and health systems identify patients […]

Valbiotis announces the release of the Universal Registration Document

LA ROCHELLE, France–(BUSINESS WIRE)–Regulatory News: Valbiotis (FR0013254851 – ALVAL, PEA / SME eligible) (Paris:ALVAL), a commercially oriented Research and Development company, committed to scientific innovation for preventing and combating metabolic and cardiovascular diseases, announces that its Universal Registration Document was filed to the French Financial Markets Regulator (AMF) April 26, […]