DUBLIN, Aug. 23, 2023 /PRNewswire/ — Today, Medtronic announced the outcome of the U.S. Food & Drug Administration (FDA) Circulatory System Devices Panel (CSDP) meeting to review data presented in support of the Medtronic Symplicity Spyral™ Renal Denervation (RDN) System. The panel Committee voted unanimously (13-0) on safety and in favor (7-6) […]
Author: Ken Dropiewski
GE HealthCare Launches CardioVisio for Atrial Fibrillation, a Digital, Patient-Centric Clinical Decision Support Tool to Enable Precision Care
CHICAGO–(BUSINESS WIRE)–Today, GE HealthCare (Nasdaq: GEHC) announces the launch of CardioVisio for Atrial Fibrillation (AFib), a digital tool designed to assist clinicians in visualizing longitudinal data relevant for disease progression from multiple data sources, and driving evidence based clinical decision support directed by up-to-date AFib guidelines. The new technology will […]
Fujifilm Launches New MRI System, ECHELON Synergy with Deep Learning Reconstruction Technology
LEXINGTON, Mass., Aug. 23, 2023 (GLOBE NEWSWIRE) — FUJIFILM Healthcare Americas Corporation, a leading provider of diagnostic imaging and medical informatics solutions, announced FDA 510(k) clearance of its new 1.5 Tesla magnetic resonance imaging (MRI) system, the ECHELON Synergy. The system employs Synergy DLR, Fujifilm’s proprietary Deep Learning Reconstruction (DLR) technology […]
Windtree Announces Issuance of Composition of Matter Patent for Dual Mechanism SERCA2a Activators by the US Patent and Trademark Office
WARRINGTON, Pa., Aug. 23, 2023 (GLOBE NEWSWIRE) — Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM: WINT), a biotechnology company focused on advancing late-stage interventions for cardiovascular disorders, today reported that the United States Patent and Trademark Office (USPTO) has issued US Patent No. 11,730,746 covering the Company’s dual mechanism […]
BioSig Introduces New Subscription Model for PURE EP™ Platform, Offering Quicker Access to Latest Features, Customizations
Westport, CT, Aug. 23, 2023 (GLOBE NEWSWIRE) — BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the “Company”), a medical technology company delivering unprecedented accuracy and precision to intracardiac signal visualization, announced today a subscription model for its PURE EP™ Platform. Cleveland Clinic—recently ranked as number one in the Nation for cardiology, heart […]
Aquedeon Medical, Inc. Receives FDA IDE Approval for the Duett Vascular Graft System
SUNNYVALE, Calif., Aug. 23, 2023 /PRNewswire/ — Aquedeon Medical, Inc., a Silicon Valley pioneering medical device company specializing in novel cardiothoracic solutions, is pleased to announce a significant milestone following receipt of FDA Investigational Device Exemption (IDE) approval to conduct a staged pivotal clinical trial for its Duett Vascular Graft System in the […]
ENDRA Life Sciences Expands Intellectual Property with Issuance of U.S. and European Patents
ANN ARBOR, Mich.–(BUSINESS WIRE)–ENDRA Life Sciences Inc. (NASDAQ: NDRA), a pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS®), announces the issuance of three new patents, one in the U.S. and two in Europe. ENDRA’s intellectual property portfolio now includes 67 issued patents worldwide, providing protection for the TAEUS® system with its novel hybrid […]
Recor Medical and Otsuka Medical Devices Announce Positive Vote from U.S. Food and Drug Administration (FDA) Advisory Committee Meeting on the Paradise™ Ultrasound Renal Denervation System for the Treatment of Hypertension
PALO ALTO, Calif.–(BUSINESS WIRE)– Recor Medical, Inc. (“Recor”) and its parent company, Otsuka Medical Devices Co., Ltd. (“Otsuka Medical Devices”) announce the U.S. Food and Drug Administration (FDA) Circulatory Systems Devices Panel of the Medical Devices Advisory Committee met to discuss the pre-market approval application (PMA) for the Paradise™ Ultrasound Renal Denervation (RDN) system, indicated to […]
BioSig’s PURE EP™ Platform Debuts New Automated Features in First Patient Cases
Westport, CT, Aug. 22, 2023 (GLOBE NEWSWIRE) — BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the “Company”), a medical technology company delivering unprecedented accuracy and precision to intracardiac signal visualization, announced today the release of new software features for the PURE EP™ Platform. The novel software features were successfully leveraged for the first […]
Medtronic reports first quarter fiscal 2024 financial results
DUBLIN, Aug. 22, 2023 /PRNewswire/ — Medtronic plc (NYSE:MDT) today announced financial results for its first quarter of fiscal year 2024 (FY24), which ended July 28, 2023. Key Highlights Revenue of $7.7 billion increased 4.5% as reported and 6.0% organic GAAP diluted earnings per share (EPS) of $0.59 decreased 16%; non-GAAP diluted EPS of $1.20 increased 6% Company increases […]
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