At-home fertility care company Mosie Baby announced it received FDA 510(k) clearance for the first over-the-counter intravaginal insemination (IVI) kit, which allows individuals to perform at-home insemination using either a fresh or cryogenically frozen…
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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:
– Syapse®, a leading real-world evidence (RWE) company dedicated to extinguishing the fear and burden of serious diseases, and the FDA Oncology Center of Excellence (OCE) today announced the renewal of…
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The FDA recalled 60 medical devices last year, and the running total for this year is 56. The good news is that there’s a startup working to make future totals lower.
The startup, named Ketryx,…
Americans can’t afford their medications. About 25% leave prescriptions unfilled, split pills, or skip doses. Seniors face challenges covering non-Medicare services, including prescriptions. Even those with commercial health insurance are not immune. One-third of…
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Virtual primary care company TytoCare announced an exclusive partnership with Idaho-based St. Luke’s Health System to provide virtual care services to the care provider’s members and employees beginning in 2024. The Israeli health tech company…
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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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What You Should Know: Paige, a global leader in end-to-end digital pathology solutions and clinical AI applications that assist in diagnosing cancer, announced it has teamed up with Nuance, a Microsoft company, to create the largest digital…
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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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