Other News

Acarix gains market acceptance in Austria; new customers orders CADScor®System for ruling out Coronary Artery Disease (CAD).

Press release Malmö, September 12, 2018 Acarix gains market acceptance in Austria; new customers orders CADScor®System for ruling out Coronary Artery Disease (CAD). Acarix AB (publ) (“Acarix”) reports first sales in Austria for its handheld CADScor®System for early rule-out of CAD. The Austrian sales mirror growing success in neighboring Germany […]

FDA to review supplemental Biologics License Application for Praluent® (alirocumab) Injection as potential treatment to reduce major adverse cardiovascular events

BRIDGEWATER, N.J. and TARRYTOWN, N.Y., Sept. 12, 2018 FDA also recently approved Praluent label update for some patients currently requiring LDL apheresis therapy /PRNewswire/ — Sanofi and Regeneron Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) for Praluent® (alirocumab) Injection, a PCSK9 inhibitor. The […]

MEDTRONIC STATEMENT REGARDING RECENT FDA WARNING LETTERS

DUBLIN – September 11, 2018 – Today, Medtronic issued the following statement confirming it has received FDA warning letters (CMS #560736 and #562437) related to its Cardiac Rhythm and Heart Failure facilities located in Mounds View, Minn., and in Juncos, Puerto Rico. The warning letters reflect earlier FDA inspection reports from […]

RenalGuard Solutions Debuts Newly Formed Reprieve Cardiovascular at Heart Failure Society of America Annual Meeting and Completes $7 Million Financing

MILFORD, Mass.–(BUSINESS WIRE)–Reprieve Cardiovascular™, a newly formed company affiliated with RenalGuard Solutions™, is a pioneering medical device company focused on improving outcomes for patients suffering from acute decompensated heart failure (ADHF). RenalGuard also announced the completion of a $7 million financing provided by strong support from existing investors and Abiomed, […]

CorFlow Completes USD 9.7M in Seed Fundin

BAAR, Switzerland–(BUSINESS WIRE)–CorFlow Therapeutics AG (www.corflow-therapeutics.ch) today announced that the company has completed the 2nd close of its Seed+ financing round. To date, and since the CorFlow foundation in 2016, the company has raised a total of USD 9.7M (CHF 9.4M) in seed funding. The seed rounds have been funded by experienced private […]

With Latest FDA 510(k), physIQ Achieves Another Clearance as a Pioneer in AI Analytics

CHICAGO–(BUSINESS WIRE)–PhysIQ, a leader in applying AI analytics to biosensor data, today announced it has received FDA 510(k) clearance for its Atrial Fibrillation (AFib) detection analytics engine. The clearance extends physIQ’s portfolio of FDA 510(k) cleared analytics designed to generate clinical insight from wearable biosensors and further establishes physIQ as a […]

CellAegis Announces Completion of Patient Enrollment in First North American Study for Innovative Heart Attack Therapy Using autoRIC®

TORONTO, Sept. 11, 2018 (GLOBE NEWSWIRE) — CellAegis Devices Inc. (“CellAegis” or the “Company”), a commercial-stage medical device company advancing innovative, non-invasive, safe and cost-effective solutions for acute and chronic cardiovascular conditions, today announced completion of patient enrollment in a large scale, investigator sponsored study (“FIRST”) to evaluate the clinical […]

BioSig Technologies, Inc. Announces 1-for-2.5 Reverse Stock Split for Pending Uplist to Nasdaq

Santa Monica, CA, Sept. 10, 2018 (GLOBE NEWSWIRE) — BioSig Technologies, Inc. (OTCQB: BSGM, OTCQB: BSGMD) (“BioSig” or the “Company”),  a medical device company developing a proprietary biomedical signal processing platform designed to address an unmet technology need for the $4.6 billion electrophysiology (EP) marketplace, today announced that the Company […]

BioSig Technologies Issues Shareholder Letter

Santa Monica, CA, Sept. 11, 2018 (GLOBE NEWSWIRE) — BioSig Technologies, Inc. (OTCQB:BSGM, OTCQB:BSGMD) a medical device company developing a proprietary biomedical signal processing platform designed to address an unmet technology need for the $4.6 billion electrophysiology (EP) marketplace, today announced that the Company has issued their September 2018 letter […]

Fujifilm Continues Partnership with American College of Radiology, Supports Education Center with Synapse® Enterprise Imaging

STAMFORD, Conn., Sept. 11, 2018 /PRNewswire/ — FUJIFILM Medical Systems U.S.A., Inc., a leading provider of Enterprise Imaging and Informatics solutions, is continuing its partnership with the American College of Radiology (ACR), a professional medical society at the forefront of innovation and education in radiology. Fujifilm provides Enterprise Imaging solutions, Synapse PACS and 3D, to support […]