Intracardiac injection

Heart Failure start-up, Acorai, embarks on the next vital stage towards regulatory approval

Retrieved on: 
Wednesday, August 16, 2023
Well, Duke University, Royal Brompton and Harefield NHS Foundation Trust, Partnership, De novo, Heart failure, Therapy, Sahlgrenska University Hospital, Prevalence, Health care, MLG, Harefield Hospital, Quality of life, Intracardiac injection, Oct, History, Teaching hospital, TCT, Duke University School of Medicine, Royal Brompton Hospital, Vital signs, Patient, Machine learning, Rigshospitalet, Algorithm, Pedigree, Mid America Heart Institute, Entrepreneurship, Coronary artery disease, FDA, City centre, Health, ICPM, Luke the Evangelist, St Luke's, Software, Medical device, Pharmaceutical industry, Kansas City metropolitan area

Acorai was designated as a breakthrough device by the US FDA in August 2023 and they aim to submit their heart monitor for regulatory approval to the FDA and CE-marking in 2024.

Key Points: 
  • Acorai was designated as a breakthrough device by the US FDA in August 2023 and they aim to submit their heart monitor for regulatory approval to the FDA and CE-marking in 2024.
  • Acorai is developing a first-of-its-kind, scalable medical device for non-invasive intracardiac pressure monitoring to improve heart failure management for more than 64 million patients worldwide.
  • Dr. Dar is a cardiologist specializing in heart failure and leads the advanced heart failure, heart transplant, and mechanical circulatory support research programme at Harefield Hospital.
  • We look forward to collaborating with Acorai, whose heart monitor may have the potential to 'change the game' in diagnostics, monitoring, and treatment of patients with heart failure."

Heart Failure start-up, Acorai, embarks on the next vital stage towards regulatory approval

Retrieved on: 
Wednesday, August 16, 2023
Well, Duke University, Royal Brompton and Harefield NHS Foundation Trust, Partnership, De novo, Heart failure, Therapy, Sahlgrenska University Hospital, Prevalence, Health care, MLG, Harefield Hospital, Quality of life, Intracardiac injection, Oct, History, Teaching hospital, TCT, Duke University School of Medicine, Royal Brompton Hospital, Vital signs, Patient, Machine learning, Rigshospitalet, Algorithm, Pedigree, Mid America Heart Institute, Entrepreneurship, Coronary artery disease, FDA, City centre, Health, ICPM, Luke the Evangelist, St Luke's, Software, Medical device, Pharmaceutical industry, Kansas City metropolitan area

Acorai was designated as a breakthrough device by the US FDA in August 2023 and they aim to submit their heart monitor for regulatory approval to the FDA and CE-marking in 2024.

Key Points: 
  • Acorai was designated as a breakthrough device by the US FDA in August 2023 and they aim to submit their heart monitor for regulatory approval to the FDA and CE-marking in 2024.
  • Acorai is developing a first-of-its-kind, scalable medical device for non-invasive intracardiac pressure monitoring to improve heart failure management for more than 64 million patients worldwide.
  • Dr. Dar is a cardiologist specializing in heart failure and leads the advanced heart failure, heart transplant, and mechanical circulatory support research programme at Harefield Hospital.
  • We look forward to collaborating with Acorai, whose heart monitor may have the potential to 'change the game' in diagnostics, monitoring, and treatment of patients with heart failure."

Acorai receives Breakthrough Device Designation for their non-invasive intracardiac pressure monitor

Retrieved on: 
Thursday, August 10, 2023
Heart failure, New Standard, HF, Intracardiac injection, SPAP, Patient, Machine learning, Motivation, External carotid artery, Ethics, System, FDA, Health, ICPM, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Breakthrough, Food, Software, Pharmaceutical industry, Medical device, Management, MD

Acorai is developing a first-of-its-kind, non-invasive intracardiac pressure monitoring (IPCM) device with a unique, patented hardware technology and proprietary machine learning system.

Key Points: 
  • Acorai is developing a first-of-its-kind, non-invasive intracardiac pressure monitoring (IPCM) device with a unique, patented hardware technology and proprietary machine learning system.
  • The Breakthrough Device application was supported by preliminary data of 281 patients from their 400-patient Swedish pilot study, which demonstrated a strong correlation to the invasive gold-standard measurements of pulmonary pressure.
  • Kasper Bourdette, Chief Operating Officer and Co-Founder added that "receiving breakthrough designation is a massive inflection point in our device development journey, and we are thrilled for the decision.
  • Implications of the Breakthrough Device Designation:
    Receiving the Breakthrough Device Designation accelerates the development and review process, underscoring the potential of Acorai to address unmet medical needs in heart failure management.

Acorai receives Breakthrough Device Designation for their non-invasive intracardiac pressure monitor

Retrieved on: 
Thursday, August 10, 2023
Heart failure, New Standard, HF, Intracardiac injection, SPAP, Patient, Machine learning, Motivation, External carotid artery, Ethics, System, FDA, Health, ICPM, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Breakthrough, Food, Software, Pharmaceutical industry, Medical device, Management, MD

Acorai is developing a first-of-its-kind, non-invasive intracardiac pressure monitoring (IPCM) device with a unique, patented hardware technology and proprietary machine learning system.

Key Points: 
  • Acorai is developing a first-of-its-kind, non-invasive intracardiac pressure monitoring (IPCM) device with a unique, patented hardware technology and proprietary machine learning system.
  • The Breakthrough Device application was supported by preliminary data of 281 patients from their 400-patient Swedish pilot study, which demonstrated a strong correlation to the invasive gold-standard measurements of pulmonary pressure.
  • Kasper Bourdette, Chief Operating Officer and Co-Founder added that "receiving breakthrough designation is a massive inflection point in our device development journey, and we are thrilled for the decision.
  • Implications of the Breakthrough Device Designation:
    Receiving the Breakthrough Device Designation accelerates the development and review process, underscoring the potential of Acorai to address unmet medical needs in heart failure management.

ŌNŌCOR Reports First-In-Human Use of the ŌNŌ Retrieval System for Percutaneous Removal of an Intracardiac Tumor

Retrieved on: 
Tuesday, August 2, 2022
Neoplasm, University, GLOBE, Echocardiography, Physician, Cardiology, Use, Muscle tissue, UW, CEO, Medical Center, McCabe, Intracardiac injection, Interventional cardiology, Safety, Section, Time-invariant system, FDA, Patient, Steinberg, LLC, Medical device, Medical imaging, DRS

PHILADELPHIA, Aug. 02, 2022 (GLOBE NEWSWIRE) -- NCOR LLC is excited to announce the first-in-human use of the N endovascular retrieval system for removal of an intracardiac tumor.

Key Points: 
  • PHILADELPHIA, Aug. 02, 2022 (GLOBE NEWSWIRE) -- NCOR LLC is excited to announce the first-in-human use of the N endovascular retrieval system for removal of an intracardiac tumor.
  • Intracardiac tumors affect thousands of patients around the world annually, but prior to N, open-heart surgery was required for removal.
  • This first-of-its-kind procedure opens the door to a new therapeutic strategy for patients around the world suffering from cardiac masses.
  • *The NCOR LLC N retrieval device is indicated for use in the cardiovascular system to retrieve foreign objects using minimally invasive procedures.

YorLabs Announces Appointment of William Starling as Chairman of the Board

Retrieved on: 
Wednesday, April 27, 2022
EP, Workflow, LLC, Cath lab, Starling, Technology, Environment, Solution, Electrophysiology, Algorithm, Intracardiac injection, LP, Cardiology, IC, Industry, Transducer, Medical imaging, Online shopping

PORTLAND, Ore., April 27, 2022 /PRNewswire-PRWeb/ -- YorLabs, a developer of cutting-edge intracardiac image guided therapy solutions, announced it has recently appointed William "Bill" Starling as chairman of the board. Starling is a leading life sciences serial entrepreneur, angel investor and venture capitalist with more than 40 years of experience in the industry. With his appointment, YorLabs has initiated the first step in building a veteran team of cardiology, ultrasound and other industry executives to enable next generation, image guided therapy solutions based on wireless integrated technologies. This could offer a significant advancement for interventional cardiology (IC) and electrophysiology (EP).

Key Points: 
  • PORTLAND, Ore., April 27, 2022 /PRNewswire-PRWeb/ -- YorLabs, a developer of cutting-edge intracardiac image guided therapy solutions, announced it has recently appointed William "Bill" Starling as chairman of the board.
  • "We are pleased to have Bill join YorLabs and help lead us into a new era of intracardiac imaging," said Anshumali Roy, founder and chief technology officer, YorLabs.
  • YorLabs is developing a world class, intracardiac image guided therapy platform with dedicated application and procedural based settings.
  • The YorLabs solution is designed to be an intuitive platform while eliminating capital outlays and significantly enhancing workflow.

Clinical Data Acquired by the PURE EP™ System Published in the Journal of Cardiac Electrophysiology

Retrieved on: 
Monday, October 4, 2021
Online, Journal of Cardiovascular Electrophysiology, Northwestern University, University of Pennsylvania, PURE, NASDAQ, University of Colorado, FHRS, Nautilus, Inc. v. Biosig Instruments, Inc., Hospital, Decision-making, Principal, University, Electrophysiology, ST, Wiley (publisher), 3D, Journal, Mayo Clinic, Manuscript, Intracardiac injection, ECG, Massachusetts General Hospital, GLOBE, Medical imaging

The PURE EP 2.0 study was conducted at three U.S. hospitals: Texas Cardiac Arrhythmia Institute at St. Davids Medical Center, Mayo Clinic Jacksonville, and Massachusetts General Hospital.

Key Points: 
  • The PURE EP 2.0 study was conducted at three U.S. hospitals: Texas Cardiac Arrhythmia Institute at St. Davids Medical Center, Mayo Clinic Jacksonville, and Massachusetts General Hospital.
  • Intracardiac signal data of clinical interest were collected during 51 cardiac ablation procedures using the PURE EP System, the signal recording system, and the 3D mapping system at the same time stamps.
  • The results from the PURE EP 2.0 study clearly validate the clinical importance of our technology and position the Company for continued growth and success.
  • The Company's first product, PURE EP (tm) System is a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording and storing of electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory.