ENGLEWOOD CLIFFS, N.J., Jan. 13, 2025 /PRNewswire/ — BRAIN.Q, is excited to announce the CE Mark for its BQ 2.0 system, designed to reduce disability following ischemic stroke, the number one cause of disability worldwide.
SEOUL, South Korea, Nov. 25, 2024 /PRNewswire/ — Neurophet, an artificial intelligence (AI) solution company for brain disease, announced on the 25th that its brain MRI analysis software “Neurophet AQUA”, has obtained 510(k) clearance from U.S. Food and Drug Administration (FDA) for its newly integrated multiple sclerosis (MS) analysis functionality.
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.
iCad (Nasdaq:ICAD) announced today that the FDA cleared its ProFound Detection version 4.0 for digital breast tomosynthesis (DBT).
LEUVEN, Belgium, Oct. 1, 2024 /PRNewswire/ — Relu, a pioneer in artificial intelligence (AI) assisted segmentation for dental labs and software companies, proudly announces the dual achievement of 510(k) clearance by the U.S. Food and Drug Administration (FDA) and CE Mark approval by an EU Notified Body. These regulatory milestones authorize the commercial distribution of the Relu® Creator, the cutting-edge dental tool that enables users to create 3D anatomical models from patients in just minutes.
Nevro (NYSE:NVRO) announced today that it received FDA approval for an AI-powered, personalized pain management platform for spinal cord stimulation.
CENTER VALLEY, Pa., Sept. 5, 2024 /PRNewswire/ — Odin Medical Ltd., an Olympus Corporation company, has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the first cloud-based Artificial Intelligence (AI) technology designed to assist gastroenterologists in detecting suspected colorectal polyps during colonoscopy procedures, the CADDIE™ computer-aided detection (CADe) device.
PARIS, Sept. 3, 2024 /PRNewswire/ — European MedTech startup AZmed, recognized as a leading company in AI for medical imaging, today announced that its Rayvolve solution has received 510(k) clearance from the Food and Drug Administration (FDA) for detecting fractures on pediatric X-rays. This milestone comes two years after receiving FDA clearance for adult fracture detection, positioning Rayvolve as a top-performing solution for detecting fractures in adult and pediatric patients. The clearance was supported by an independent study conducted with SimonMed Imaging, one of the largest outpatient imaging providers in the U.S.