CAMPBELL, Calif.–(BUSINESS WIRE)–Simpson Interventions, Inc., a pioneering medical technology company specializing in cardiovascular interventional devices, today announced that its groundbreaking Acolyte Image Guided Crossing and Re-Entry Catheter System has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA). “We are thrilled to receive FDA’s Breakthrough Device […]
Other News
Acarix announces the initiation of the first US-based clinical workflow evaluation study
NEW YORK, April 11, 2024 /PRNewswire/ — Acarix, a leader in advanced acoustic-based cardiac diagnostics, announces the initiation of the first US-based clinical study to collect real-world data to compare workflows between traditional stress tests and the CADScor System. The focus is on…
InfoBionic Rebrands Company Name to ‘InfoBionic.Ai’, Reinforcing Focus on AI-Enabled ECG
April 09, 2024 07:20 PM Eastern Daylight Time BOSTON–(BUSINESS WIRE)–InfoBionic.Ai, a digital health company providing AI-powered diagnostic remote patient monitoring solutions, today announced that it has evolved its company name from ‘InfoBionic’ to ‘InfoBionic.Ai,’ signifying its continued commitment to leveraging artificial intelligence in virtual cardiac care. “We are proud to […]
AbbaDox Announces Partnership with Radiology Imaging Associates
The collaboration marks a significant step towards operational efficiency and enhanced patient care across 17 locations in Florida and the US Virgin Islands. [SUMMARY]: AbbaDox is proud to announce a strategic partnership with Radiology Imaging Associates, aimed at enhancing radiology…
AdrenoMed Receives FDA Fast Track Designation for Enibarcimab for Treatment of Septic Shock
HENNIGSDORF, Germany and BERLIN, April 10, 2024 (GLOBE NEWSWIRE) — AdrenoMed AG, the vascular integrity company, today announced that the US Food and Drug Administration (FDA) has granted Fast Track designation to its lead product candidate enibarcimab, a first-in-class non-neutralizing monoclonal antibody, for the treatment of septic shock. AdrenoMed is now preparing a confirmatory Phase IIb/III clinical trial to confirm the reduced septic shock mortality under enibarcimab treatment employing a precision medicine approach.
Silk Road Medical to Report First Quarter 2024 Financial Results on April 30, 2024
SUNNYVALE, Calif., April 09, 2024 (GLOBE NEWSWIRE) — Silk Road Medical, Inc. (Nasdaq: SILK), a company focused on reducing the risk of stroke and its devastating impact, today announced it will report financial results for the first quarter 2024 after market close on Tuesday, April 30th, 2024. Company management will host a corresponding audio webcast beginning at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time.
First Look at Data on Biosense Webster Dual Energy THERMOCOOL SMARTTOUCH™ SF Platform for Atrial Fibrillation Presented at EHRA Congress
Irvine, CA (April 9, 2024) – Biosense Webster, Inc., a global leader in cardiac arrhythmia treatment and part of Johnson & Johnson MedTech, today announced three-month follow-up results from the SmartfIRE clinical trial, unveiled in a late-breaking presentation by Dr. Tom De Potter,i an investigator in the study, during the annual meeting […]
Nuwellis Announces Launch of Ultrafiltration Therapy Using Aquadex Smartflow® System at Henry Ford Health
MINNEAPOLIS, April 09, 2024 (GLOBE NEWSWIRE) — Nuwellis, Inc. (Nasdaq: NUWE) today announced that Detroit, Michigan-based health system, Henry Ford Health, has begun offering ultrafiltration therapy to heart failure patients suffering from fluid overload using the company’s Aquadex SmartFlow system as part of Nuwellis’ pivotal REVERSE-HF clinical study. “We are […]
Silence Therapeutics Announces JAMA Publication of Additional Phase 1 Data for Zerlasiran in Subjects with Elevated Lipoprotein(a)
LONDON–(BUSINESS WIRE)–Silence Therapeutics plc, Nasdaq: SLN (“Silence” or the “Company”), an experienced and innovative biotechnology company committed to transforming people’s lives by silencing diseases through precision engineered medicines, today announced additional results from the APOLLO phase 1 study of zerlasiran (SLN360) in subjects with baseline lipoprotein(a), or Lp(a), levels at […]
HeartBeam Presents Positive Results on its Artificial Intelligence Capabilities for Detecting Arrhythmias
New Data Presented at the European Heart Rhythm Association Conference Marks First Scientific Presentation on HeartBeam AI, the Company’s Deep Learning Technology Data Shows HeartBeam AI Combined with VCG Greatly Improves Detection of Atrial Flutter over Single-Lead ECGs Found in Leading Smartwatches and Other Wearables April 09, 2024 08:31 AM […]
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