Author: Ken Dropiewski

LivaNova to Announce Fourth-Quarter and Full-Year 2022 Results

LONDON–(BUSINESS WIRE)–LivaNova PLC (Nasdaq: LIVN), a market-leading medical technology and innovation company, will host a conference call to discuss its fourth-quarter and full-year 2022 results on Wednesday, February 22, 2023 at 1 p.m. London time (8 a.m. Eastern Time). The Company will release its fourth-quarter and full-year 2022 results prior […]

Abbott Receives FDA Approval for Navitor™, a Next-Generation TAVI System Designed to Treat Aortic Stenosis

Abbott’s new Navitor device features advancements to improve patient care, including reducing or eliminating risk of blood leakage around valve implant Transcatheter aortic valve implantation (TAVI) offers minimally invasive alternative to surgery for people with aortic stenosis, a common and life-threatening heart valve disease ABBOTT PARK, Ill., Jan. 17, 2023 /PRNewswire/ — […]

Biobeat Demonstrates Prediction Capabilities of Its Devices in Heart Failure Patients under Diuresis

Peer-reviewed study published in Journal of Clinical Medicine validates the use of Biobeat’s wrist monitor for advanced noninvasive hemodynamic monitoring in HF patients PETAH TIKVA, Israel, Jan. 17, 2023 /PRNewswire/ — Biobeat, a global leader in wearable remote patient monitoring solutions for the healthcare continuum, today announced the publication of clinical data demonstrating that […]

CytoSorbents Appoints Irina B. Kulinets, PhD, as Senior Vice President of Global Regulatory Affairs

Dr. Irina Kulinets, seasoned U.S. and international medical device regulatory expert, joins CytoSorbents’ executive management team to lead FDA marketing approval of DrugSorb®-ATR and other global regulatory priorities PRINCETON, N.J., Jan. 17, 2023 /PRNewswire/ — CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using […]

First Patient Enrolled in REAL SSO2 Study to Evaluate Clinical Utility and Economic Value of ZOLL TherOx SSO2 Therapy

CHELMSFORD, Mass.–(BUSINESS WIRE)–ZOLL, an Asahi Kasei company, announced today that the first patient has enrolled in the REAL SSO2 post-market observational study to assess the clinical utility and cost-effectiveness of TherOx SuperSaturated Oxygen (SSO2) Therapy compared to PCI alone in standard of care treatment for ST-elevation myocardial infarction (STEMI) patients. The […]

NewAmsterdam Announces Positive Results from ROSE2, Phase 2 Trial Evaluating Obicetrapib in Combination with Ezetimibe as an Adjunct to High-Intensity Statin Therapy

— Achieved primary endpoint with statistically significant reduction in LDL-C (p < 0.0001) — — Median percent change in LDL-C of -59% in combination arm compared to -6% in placebo arm — — Favorable safety and tolerability — — Data support advancement of fixed-dose combination into bioequivalence and Phase 3 […]

Pulnovo Medical Announces Dr. Mingdong Zhang, Former FDA Medical Device Officer Joins Scientific Advisory Board

SHANGHAI, Jan. 14, 2023 /PRNewswire/ — Pulnovo Medical Limited, a globally recognized OTM platform, announced the appointment of Dr. Mingdong Zhang to the company’s Scientific Advisory Board (SAB). Dr. Zhang will provide guidance on Pulnovo Medical’s clinical development and registration strategyand supporting the company’s global development plan. Pulnovo Medical is a medical device company […]

Pie Medical Imaging announces the global release of its latest echocardiography software technology, CAAS Qardia 2.0

MAASTRICHT, Netherlands, Jan. 13, 2023 /PRNewswire/ — Pie Medical Imaging (“PMI”), a global leader in cardiac imaging, today launched CAAS Qardia 2.0, a new version of their innovative echocardiography software platform. CAAS Qardia leverages artificial intelligence driven workflows for performing key clinical measurements and ease-of-access. The CAAS Qardia platform offers in-hospital deployment as so-called zero-footprint solution, meaning access from any PC within the […]