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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Virtual and augmented reality are gaining wider acceptance in healthcare. While there are still challenges and deployment hurdles, more and more organizations are using AR and VR as the technologies evolve and the many benefits…
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UK-based digital health tech company Huma has received FDA 510(k) Class II clearance for its configurable disease-agnostic Software as a Medical Device platform, which includes the company’s cardiovascular risk score algorithm. The company, which received…
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Huma Therapeutics has received US Food and Drug Administration (FDA) Class II clearance for its disease-agnostic Software-as-a-Medical-Device (SaMD) platform, enabling companies to launch their own algorithm innovations more quickly to the platform and allowing…
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