Other News

Catasys’ Telehealth-Enabled OnTrak™ Programs See Surge in Enrollment and Engagement Amidst COVID-19 Pandemic

Customer Expansions Continue as Effective Outreach Pool Climbs to 145,000, Up 34% from Q4 2019 SANTA MONICA, Calif.–(BUSINESS WIRE)–Catasys, Inc. (NASDAQ: CATS) (“Catasys” or the “Company”), a leading AI-powered and telehealth-enabled, virtualized outpatient healthcare treatment company, today announced that the Company is surpassing a weekly rate of 500 member enrollments for the […]

Foldax® Completes Enrollment in Tria LifePolymer™ Early Feasibility Study

Company demonstrates excellent progress in its surgical aortic heart valve study SALT LAKE CITY–(BUSINESS WIRE)–Foldax® announced today that it has completed initial enrollment in its early feasibility study (EFS) for the Tria LifePolymer™ heart valve. Fifteen patients have been enrolled in 4 participating sites. “The study is progressing well and we […]

MCRA Launches Medical Device U.S. FDA Regulatory & Clinical Trial Advisory Support & Call Center to Assist with the COVID-19 Pandemic

WASHINGTON, March 24, 2020 /PRNewswire/ — MCRA, LLC, a leading medical device advisory firm and CRO with specialization in regulatory affairs, clinical research, reimbursement, compliance, and quality assurance, has implemented a call center to keep medical device manufacturers informed of government and site decisions that impact regulatory submissions, clinical study operations, or quality […]

Canon Medical Receives FDA Clearance for Compressed SPEEDER Technology for 3T MR System

New Technology on the Vantage Galan 3T Can Help Clinicians Reduce Scan Times TUSTIN, Calif.–(BUSINESS WIRE)–Physicians can now scan faster with the newly FDA-cleared Compressed SPEEDER technology from Canon Medical Systems USA, Inc. Available on the Vantage Galan 3T MR system, Compressed SPEEDER technology speeds up MRI scan times by reconstructing full resolution images […]

New FDA Guidance Allows Use of KardiaMobile 6L to Measure QTc in COVID-19 Patients

World’s only FDA-cleared six-lead personal ECG will be used by healthcare professionals to monitor QT duration in patients receiving medications that can cause potentially life threatening QT prolongation. MOUNTAIN VIEW, Calif., March 23, 2020 /PRNewswire/ — AliveCor, the leader in artificial intelligence (AI)-based, personal ECG technology, and provider of enterprise cardiology solutions, today […]

Janssen Highlights Continued Commitment to Cardiovascular & Metabolic Healthcare Solutions with Late-Breaking Data at the First Fully Virtual American College of Cardiology Scientific Session

Highlights include four late-breaking XARELTO® (rivaroxaban) abstracts Four INVOKANA® (canagliflozin) abstracts from the pivotal CREDENCE study will also be presented RARITAN, N.J., March 20, 2020 /PRNewswire/ — The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that it will unveil late-breaking data from its leading cardiovascular and metabolism portfolio during the […]

CHF Solutions’ Aquadex FlexFlow® System is licensed and approved for sale in India

EDEN PRAIRIE, Minn., March 19, 2020 (GLOBE NEWSWIRE) — CHF Solutions (Nasdaq: CHFS) today announced the Aquadex FlexFlow system has been licensed and approved for sale in India, making ultrafiltration therapy available for patients suffering from hypervolemia, or fluid overload, in one of the largest countries in the world. “We […]

Novartis announces NEJM publication of three pivotal trials showing durable and potent efficacy of inclisiran, an investigational first-in-class siRNA cholesterol-lowering therapy

– Inclisiran, an investigational medicine, showed durable and potent reduction of low-density lipoprotein cholesterol (LDL-C) in patients with atherosclerotic cardiovascular disease (ASCVD), ASCVD risk equivalents and heterozygous familial hypercholesterolemia (HeFH)[1,2] – Inclisiran reduced LDL-C at 17 months by 52% in patients with ASCVD (ORION-10), 50% for ASCVD and ASCVD risk […]

Sequana Medical Announces 2019 Full Year Results and 2020 Outlook

Continued strong progress in U.S. NASH-related and global heart failure programs Successfully raised €19 million in Q1 2020 extending cash runway into H1 2021 Conference call with live webcast presentation today at 14:00 CET / 09:00 ET GHENT, Belgium, March 19, 2020 (GLOBE NEWSWIRE) — Sequana Medical NV (Euronext Brussels: SEQUA, the “Company”), an […]