Medtronic receives CE Mark for Endoflip system
November 14, 2024
Endoflip is an advanced diagnostic tool that can help expedite accurate diagnosis of oesophageal motility disorders, conditions often missed during endoscopies.
Endoflip is an advanced diagnostic tool that can help expedite accurate diagnosis of oesophageal motility disorders, conditions often missed during endoscopies.
The system is designed to shorten scan times, which may be better for people who struggle to stay still or have claustrophobia, and to detect more subtle abnormalities.
EINDHOVEN, The Netherlands, Nov. 14, 2024 /PRNewswire/ — Xeltis, a leading developer of transformative implants that enable the natural creation of living and long-lasting vessels, today announces that the Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has granted aXess Breakthrough Device Designation status. aXess is Xeltis’ vascular access conduit, which enables the creation of a new, permanent, living vessel for hemodialysis vascular access.
BOSTON and LEUVEN, Belgium, Nov. 14, 2024 /PRNewswire/ — Why this news will impact the lives of people affected by Alzheimer’s disease:
SAN FRANCISCO, Nov. 14, 2024 /PRNewswire/ — Eko Health, a pioneer in applying artificial intelligence for early detection of heart and lung diseases, today announced the issuance of a Category III Current Procedural Terminology (CPT) code by the American Medical Association (AMA) for its SENSORA™ platform. The newly issued Category III CPT code will be effective on July 1, 2025, and is the first step to coverage and reimbursement for SENSORA™, bringing advanced heart disease detection to clinicians across the U.S.
HOFFMAN ESTATES, Ill., Nov. 14, 2024 /PRNewswire/ — In a pivotal stride to address the growing AFib epidemic, OMRON Healthcare today announced the U.S. Food and Drug Administration (FDA) has granted the company its De Novo authorization to market new home blood pressure monitors featuring breakthrough AI-powered atrial fibrillation detection. In a medical device first, OMRON’s novel machine learning IntelliSense™ AFib algorithm automatically analyzes the Pressure Pulse Wave generated during blood pressure measurement to detect AFib, a leading cause of stroke.
VADUZ, Liechtenstein, Nov. 14, 2024 /PRNewswire/ — Implantica AG (publ.), a medtech company at the forefront of introducing advanced technology into the body, including the unique device RefluxStop™ for the treatment of acid reflux, a treatment field with 1 billion sufferers, announces the submission of the second clinical module of the Premarket Approval (PMA) application to the US FDA for RefluxStop™ along with responses to the FDA’s findings from the first module.
Kamen and Sequel Medtech CEO Alan Lotvin say they are offering greater precision in insulin delivery with new pump technology in the Twiist device.
SAN MATEO, Calif., Nov. 13, 2024 /PRNewswire/ — SonoMotion, a medical device company developing non-invasive solutions for kidney stones, announced today that the FDA has granted de novo clearance for the Company’s Stone Clear™ device for the anesthesia-free treatment of post-lithotripsy kidney stone fragments.
LAUSANNE, Switzerland, Nov. 13, 2024 /PRNewswire/ — SmartCardia has received FDA clearance for Mobile Outpatient Cardiac Telemetry (OCT/MCT) for its 7-lead live ECG monitoring patch and cloud platform. SmartCardia’s 7L patch is easy-to-wear, cable-free, waterproof and can be used for continuous monitoring for up to 14 days