Author: Ken Dropiewski

Sensome Receives FDA “Breakthrough Device Designation” for its AI-powered Stroke Guidewire

PARIS–(BUSINESS WIRE)–Sensome, the company pioneering the connected medical device revolution with the world’s smallest biological tissue sensor, announced today that it has been granted a Breakthrough Device designation by the Center of Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) for its Clotild® Smart Guidewire System designed […]

Medtronic Receives FDA Expanded Approval for Arctic Front™ Family of Cardiac Cryoablation Catheters for Initial Use for Recurrent Symptomatic Paroxysmal Atrial Fibrillation

– First and Only Approval to Indicate Cryoablation as an Initial Rhythm Control Strategy – Offers Safe, Effective Alternative to Antiarrhythmic Drug Therapy for the Prevention of Atrial Arrythmia Recurrence DUBLIN, June 21, 2021 /PRNewswire/ — Medtronic plc (NYSE: MDT), the global leader in medical technology, today announced it received U.S. Food and Drug […]

Centerline Biomedical Adds Two Expert Advisors to Advance New Clinical Applications

Dr. Azeem Latib and Doug Teany join to bring deep subject matter expertise in coronary and structural heart procedures as well as robotic surgery CLEVELAND, June 21, 2021 /PRNewswire/ — Centerline Biomedical, Inc. (Centerline), a spinoff of Cleveland Clinic, today announced the appointment of two key advisors. As Centerline launches its flagship Intra-Operative […]

LifeQ Partners with CONNEQT Wearable Device to Enable Greater Clinical Health Insights

Leading provider of wearable device-derived health data partners with vascular health-tech firm to provide industry-leading health insights for clinical and other users ATLANTA, June 21, 2021 /PRNewswire/ — LifeQ, the world’s preeminent provider of biometrics and health information derived from wearable devices, has partnered with CONNEQT, Inc, a consumer health company offering home […]

BioCardia Announces European Patent Office Decision to Grant Patent on Autologous Cell Therapy Patient Selection Diagnostic Assay

SAN CARLOS, Calif., June 21, 2021 (GLOBE NEWSWIRE) — BioCardia®, Inc. [Nasdaq: BCDA], a company focused on cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced that the European patent office has issued a Decision to Grant European Patent No. 3593810 to BioCardia with publication on June 23, 2021. […]

Cleerly Launches with $43 Million Series B to Provide a New Standard of Care for the Leading Cause of Death – Heart Disease

Resulting from More than a Decade of Clinical Research, Company Unveils Non-Invasive Approach to Identify, and New Care Pathways to Address Heart Disease Using Artificial Intelligence NEW YORK–(BUSINESS WIRE)–Cleerly, the company creating a new standard of care for heart disease, launched today with $43 million in Series B funding and […]

NorthStar Medical Technologies, LLC Announces Appointment of Frank Scholz, Ph.D., as Senior Vice President and Chief Operating Officer

BELOIT, Wis.–(BUSINESS WIRE)–NorthStar Medical Technologies, LLC, a global innovator in the development, production and commercialization of diagnostic and therapeutic radiopharmaceuticals, today announced the appointment of Frank Scholz, Ph.D., as Senior Vice President and Chief Operating Officer. In this new position, he brings more than 20 years of relevant operational experience […]

Sky Labs Finalizes Series B Round Successfully Planning to Take Over Global Markets

– European sales contract for heart monitoring platform ‘CART-I’ – USD 30 million accumulated investment for overseas clinical research and marketing SEONGNAM, South Korea–(BUSINESS WIRE)–Attracting USD 20 million investment, Sky Labs (CEO: Jack Lee), a global health care start-up, finalized Series B Round successfully. The accumulated amount of investment Sky Labs has […]

Jardiance® (empagliflozin) approved in Europe for the treatment of heart failure with reduced ejection fraction

– This new indication is based on the EMPEROR-Reduced trial, which showed a significant 25 percent reduction in the combined relative risk versus placebo of cardiovascular death or hospitalization for heart failure with reduced ejection fraction in adults with or without diabetes and an eGFR of ≥20ml/min/1.73 m2 – Heart failure […]

Nuevocor closes US$24M Series A Financing to Advance Novel Gene Therapies for Cardiomyopathies

SINGAPORE, June 18, 2021 /PRNewswire/ — Nuevocor, a preclinical-stage biotech company specializing in gene therapy for cardiomyopathies, has announced the completion of an oversubscribed $24 million Series A financing round. The round was co-led by EVX Ventures and Boehringer Ingelheim Venture Fund (BIVF), with EDBI, Xora Innovation, SEEDS Capital and other investors joining the syndicate. The […]