Other News

Synchron Secures $40M in Series B led by Khosla Ventures to Launch U.S. Clinical Trials of Minimally Invasive Brain Computer Interface

Synchron’s flagship StentrodeTM endovascular implant does not require open brain surgery and has obtained FDA Breakthrough Device Designation for the treatment of paralysis The New York based company is already conducting human trials in Australia and is expected to commence a U.S. clinical trial in 2021 NEW YORK–(BUSINESS WIRE)–Synchron, a brain […]

FDA Alerts Health Care Providers to Stop New Implants of Certain Ventricular Assist Device System

SILVER SPRING, Md., June 3, 2021 /PRNewswire/ — The U.S. Food and Drug Administration is alerting health care providers to no longer implant end-stage heart failure patients with Medtronic’s Heartware Ventricular Assist Device (HVAD) System due to a growing body of observational clinical comparisons that demonstrates a higher frequency of neurological adverse events and […]

CardioFocus Announces Agreement with China Grand Pharmaceutical to Bring HeartLight X3 System to China

– China Grand Pharma will seek regulatory approvals and commercialize CardioFocus’ innovative catheter ablation technology for pulmonary vein isolation – Pulmonary vein isolation is the gold standard treatment for atrial fibrillation MARLBOROUGH, Mass., June 2, 2021 /PRNewswire/ — CardioFocus, Inc., a medical device company dedicated to advancing ablation treatments for atrial fibrillation (AFib), […]

Edwards Receives Clearance For Hypotension Prediction Index Software For Noninvasive Acumen IQ Cuff

IRVINE, Calif., June 1, 2021 /PRNewswire/ — Edwards Lifesciences (NYSE: EW) today announced that Acumen Hypotension Prediction Index (HPI) software with the Acumen IQ finger cuff has received U.S. Food and Drug Administration clearance. This is the first noninvasive solution that unlocks Acumen HPI software and uses machine learning to alert clinicians of the […]

SoundBite Medical’s Shock Wave Technology Continues to Crack Through Severe Calcium with the Addition of its First US Site

MONTREAL–(BUSINESS WIRE)–SoundBite Medical Solutions Inc. (SBMS), a medical device company dedicated to developing solutions for the interventional treatment of calcific peripheral and coronary arterial diseases, today announced the use of its novel Active Wire 0.014” platform at a first site in the United States in the successful treatment of patients suffering from […]

AliveCor Acquires CardioLabs and Sets the Stage for the Launch of Advanced Ambulatory Monitoring Services

MOUNTAIN VIEW, Calif., June 2, 2021 /PRNewswire/ — AliveCor, the global leader in FDA-cleared personal electrocardiogram (ECG) technology and services, today announced that it has acquired the independent diagnostic testing facility (IDTF) CardioLabs, a leading monitoring and cardiac diagnostic service provider. The acquisition is a cornerstone of AliveCor’s mission to extend its comprehensive […]

AI triage solution for deadly vascular conditions receives FDA clearance and CE Mark

Avicenna.AI announces the introduction of CINA CHEST, including AI tools for detection and emergency triage of pulmonary embolism and aortic dissection MARSEILLE, France , June 2, 2021 /PRNewswire/ — Medical imaging AI specialist Avicenna.AI today announced that it has received certification in the United States and European Union for CINA CHEST, its new AI solution that leverages […]

Prytime Medical Closes Oversubscribed $6M Inside Funding Round to Fuel Commercialization Growth

The capital will be used to accelerate the commercialization of Prytime Medical’s new line of minimally invasive REBOA (Resuscitative Endovascular Balloon Occlusion of the Aorta) hemorrhage control products. SAN ANTONIO, June 2, 2021 /PRNewswire/ — Prytime Medical Inc – The REBOA CompanyTM, is a leading innovator and global provider of life saving […]

Betagenon AB announces investment and collaboration with Hong Kong-based MCG Technology Group Ltd

STOCKHOLM, June 2, 2021 /PRNewswire/ — Betagenon AB, a Sweden-based biotech company focused on development of AMPK activator compounds, and MCG Technology Group Ltd, a Hong Kong-based biotech investment group, today announced that MCG Technology Group will invest in and collaborate with Betagenon. MCG Technology Group will invest 2M USD in exchange for Betagenon equity.  Additionally, both […]