MedTech News
FDA authorizes the first AI-driven MRI solution for safer Alzheimer’s treatment
BOSTON and LEUVEN, Belgium, Nov. 14, 2024 /PRNewswire/ — Why this news will impact the lives of people affected by Alzheimer’s disease:
Eko Health Granted Category III CPT Code for SENSORA™ AI Heart Disease Detection Platform
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.
FDA Grants De Novo Authorization to OMRON Healthcare for New Blood Pressure Monitors with AI-Powered AFib Detection Feature
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.
Implantica submits FDA PMA application Clinical Module 2 for RefluxStop™ for U.S. market approval
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.
Dean Kamen, insulin pump pioneer, wants to shake up diabetes tech
Kamen and Sequel Medtech CEO Alan Lotvin say they are offering greater precision in insulin delivery with new pump technology in the Twiist device.
SONOMOTION ANNOUNCES FDA DE NOVO CLEARANCE FOR ITS STONE CLEAR™ 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.
SmartCardia Receives FDA Clearance for Outpatient Cardiac Telemetry for Its 7-Lead ECG Patch and Cloud Platform
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
Johnson & Johnson wins FDA IDE for Ottava surgical robot
Johnson & Johnson MedTech announced today that the FDA granted its Ottava surgical robot investigational device exemption (IDE).