Bering Limited’s achievement of FDA clearance for BraveCX, an AI-powered chest X-ray triage tool, represents a significant breakthrough in the field of medical technology. This milestone not only underscores the company’s commitment to innovation…
Continue Reading
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…
Continue Reading
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…
Continue Reading
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…
Continue Reading
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…
Continue Reading
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…
Continue Reading
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…
Continue Reading
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…
Continue Reading
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…
Continue Reading
