What You Should Know:
– Smileyscope™, a pioneer in virtual reality (VR) therapeutic solutions, has received Class II clearance from the U.S. Food and Drug Administration (FDA) for its Smileyscope™ Therapy system.
– The FDA clearance…
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What You Should Know: Mosie Baby, a pioneering at-home fertility care company, has secured FDA Class II clearance for its Mosie Baby Kit making it the first and only FDA-cleared over-the-counter kit for use…
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What You Should Know:
– GE Healthcare (Nasdaq: GEHC) announced the US FDA 510K clearance of Critical Care Suite 2.1, featuring an innovative pneumothorax (PTX) detection algorithm that helps clinicians quickly and accurately identify and…
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SyntheticMR’s SyMRI 3D, pending FDA clearance, heralds a transformative era in medical imaging. This pioneering technology introduces unparalleled capabilities, enabling precise brain region analysis and comprehensive lesion assessments. SyMRI 3D’s isotropic resolution promises enhanced…
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4D Medical achieves FDA clearance for CT LVAS, a game-changing CT-based ventilation software complementing its XV LVAS. This advanced technology, showcased at RSNA 2023, enriches CT scans with detailed functional insights, empowering radiologists to…
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“NeuroShield,” by InMed.AI, secures FDA clearance as a pioneering AI-driven tool quantifying brain volumes from MRI data. This groundbreaking platform offers ethnicity-specific reference ranges and aids neurodegenerative disease diagnosis and treatment planning. With impressive…
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AI’s impact on healthcare unfolds through HEALWELL AI’s acquisition of Pentavere, fortifying data-driven diagnostics. Forward Health introduces CarePods, reshaping accessibility to comprehensive medical services. Lunit’s FDA clearance for breast cancer detection highlights AI’s pivotal…
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AIRS Medical has entered a strategic partnership with MRI pioneer FONAR Corporation to advance healthcare solutions in North America. Leveraging FONAR’s 45 years of MRI expertise, AIRS Medical’s SwiftMR, an AI-driven imaging enhancement technology,…
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What You Should Know: – RapidAI has received FDA clearance for Rapid SDH, its AI-powered module for the detection and notification of suspected hemispheric acute and chronic subdural hematoma. – The need for the…
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Soundwave Hearing has gained FDA clearance for its Sontro Self-Fitting Over-the-Counter (OTC) Hearing Aids. These advanced hearing aids, combined with the otoTune app, harness AI and personalization to address mild to moderate hearing impairments…
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