Author: Ken Dropiewski

Itamar™ Medical Announces Third Quarter Preliminary Revenue Results and Reinstates Revenue Guidance for Full Year 2020

Q3 Total Revenue Results of $10.7M to $11.0M, reflecting growth of 32%-36% Q3 U.S. WatchPAT Revenue Results of $8.6M to $8.9M, reflecting growth of 51%-56% Full Year 2020 Revenue Guidance of $39.5M to $40.5M CAESAREA, Israel, Oct. 13, 2020 (GLOBE NEWSWIRE) —  Itamar Medical Ltd. (Nasdaq: ITMR) (TASE: ITMR), a leading medical device and digital health company focused on the diagnosis […]

InspireMD Announces Renowned Interventional Cardiologist Gary S. Roubin, M.D., Ph.D., to Join Board of Directors

TEL AVIV, Israel, Oct. 13, 2020 (GLOBE NEWSWIRE) — InspireMD, Inc. (NYSE American: NSPR), the developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of stroke caused by carotid artery disease (CAD), today announced the addition of Gary Roubin, M.D., Ph.D., to InspireMD’s Board of Directors. Dr. Gary […]

Brain Scientific Seeks FDA Approval of Next-Gen NeuroCap™ EEG Cap Amidst New Data on Neurological Problems in COVID Patients

NEW YORK, Oct. 13, 2020 (GLOBE NEWSWIRE) — via NewMediaWire — Brain Scientific Inc. (OTCQB: BRSF), a neurology-focused medical device and software company, has submitted a premarket 510(k) application to the United States Food and Drug Administration for its next generation NeuroCap™ device. NeuroCap™ is an advanced Electroencephalogram (EEG) electrode array used to obtain rapid EEGs in […]

WaveClear, Inc Raises $1.125 Million in Series-A Funding Led by Hunniwell Lake Ventures

SAN FRANCISCO, Oct. 13, 2020 /PRNewswire/ — WaveClear, Inc., a medical device start-up pioneering the deployment of therapeutic ultrasound technologies to combat vascular diseases, recently announced today the closing of a $1,125,000 Series-A round of investment led by Palo Alto-based medical device venture capital firm, Hunniwell Lake Ventures (“HLV”). Peripheral vascular diseases are increasing worldwide, and […]

Foldax Named Cardiovascular Device Company of the Year by MedTech Outlook

SALT LAKE CITY–(BUSINESS WIRE)–Foldax® announced today that it has been selected as Company of the Year among 10 cardiovascular device company finalists by MedTech Outlook Magazine. Foldax was honored for its innovative Tria™ heart valve, the first biopolymer heart valve to receive FDA approval for a U.S. clinical trial. Foldax has reinvented every […]

GE Healthcare Receives FDA Clearance for Vivid Ultra Edition, AI-Powered Cardiovascular Ultrasound System Designed to Shorten Diagnostic Exam Time and Improve Measurement Consistency

CHICAGO–(BUSINESS WIRE)–GE Healthcare today announced U.S. FDA 510k clearance for its Ultra Edition package on Vivid1 cardiovascular ultrasound systems, which includes new features based on artificial intelligence (AI) that enable clinicians to acquire faster, more repeatable exams consistently. Methodical assessments of heart function are key in echocardiography but can be tedious […]

CARMAT is granted €13 million in national innovation funding to conduct the EFICAS study in France

PARIS–(BUSINESS WIRE)–Regulatory News: CARMAT (FR0010907956, ALCAR) (Paris:ALCAR), the designer and developer of the world’s most advanced total artificial heart, aiming to fulfill an unmet medical need by providing a therapeutic alternative to people suffering from end-stage biventricular heart failure, today announces that it has been granted €13 million in funding […]

LivaNova Presents New Data at European Association for Cardio-Thoracic Surgery Annual Meeting Demonstrating Benefits of Perceval Sutureless Valve

New PERSIST-AVR study results and SURE-AVR registry data analysis underscore utility of Perceval as a minimally invasive surgical approach for patients with aortic valve stenosis LONDON–(BUSINESS WIRE)–LivaNova PLC (NASDAQ:LIVN) a market-leading medical technology and innovation company, today announced new data from the Perceval® Sutureless Implant Versus Standard-Aortic Valve Replacement (PERSIST-AVR) clinical study and […]

Zynex Announces 96% Year over Year Order Growth

ENGLEWOOD, Co., Oct. 12, 2020 /PRNewswire/ — Zynex, Inc. (NASDAQ: ZYXI), an innovative medical technology company specializing in manufacturing and selling non-invasive medical devices for pain management, stroke rehabilitation, cardiac monitoring and neurological diagnostics, today announced orders for Q3 2020. Thomas Sandgaard, CEO of Zynex said: “Similar to most companies we have seen the impact […]