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First Cloud-Based AI Endoscopy System for Colonoscopy Receives FDA Clearance

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.

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Vesalio launches pVasc Thrombectomy System in the U.S. for peripheral occlusions

PLANO, Texas, Sept. 4, 2024 /PRNewswire/ — Vesalio announces the U.S. commercialization of pVasc™ Thrombectomy System for non-surgically removing peripheral occlusions. pVasc targets the full range of embolisms from soft, acute clots to fibrin-rich, calcified ones, enabling a fast and safe removal. Its unique Drop Zone™ technology traps, retains and securely removes thrombus to restore flow in patients suffering from acute limb ischemia (ALI) and other conditions related to peripheral artery disease (PAD).

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US FDA Grants Clearance for DaylightRx

SAN FRANCISCO, Sept. 4, 2024 /PRNewswire/ — Big Health, a leading developer of digital mental health treatments, has been granted clearance by the U.S. Food and Drug Administration (FDA) for its digital therapeutic, DaylightRx. DaylightRx is a prescription device delivering Cognitive Behavioral Therapy and can be made available on the order of a licensed healthcare provider. DaylightRx is a digital therapeutic intended to treat generalized anxiety disorder (GAD) by improving a patient’s GAD symptoms as an adjunct to usual care in patients aged 22 years and older.

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AliveDx Receives IVDR-CE Mark for Multiplexed Assay to Accurately Detect Celiac Disease (CD) on the MosaiQ® System

EYSINS, Switzerland, Sept. 3, 2024 /PRNewswire/ — At AliveDx, our mission is to empower diagnostic insights, transform patient care, and innovate for life. We are excited and proud to announce AliveDx has received IVDR-CE mark certification for its multiplexed MosaiQ AiPlex™ CD microarray immunoassay, designed to improve the accuracy and speed of diagnosing celiac disease

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