What You Should Know:
– Curavit Clinical Research, a leader in decentralized clinical trials (DCTs) for digital therapeutics (DTx), successfully completed a study for the Sana Device, a virtual reality (VR) mask aiming to reduce…
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Nanox’s HealthFLD, an AI-powered software, has received FDA clearance for automated analysis of liver attenuation from CT scans. This breakthrough technology facilitates early detection of fatty liver, aiding clinicians in diagnosing metabolic diseases. With…
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What You Should Know:
– Samsung’s Galaxy Watch has received De Novo authorization from the US Food and Drug Administration (FDA) for its sleep apnea detection feature.
– This marks a significant step forward in wearable…
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Visibly, a leading healthcare technology company, is thrilled to announce the merger of Visibly and EyecareLive. As the developer of the world’s first FDA-cleared online visual acuity test, Visibly is committed to growing convenient access…
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Hologic’s Genius Digital Diagnostics System, empowered by the Genius Cervical AI algorithm, has received FDA approval, marking a significant advancement in cancer screening technology. This innovative system integrates deep learning AI with advanced imaging…
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Medical technology firm Hologic has been granted clearance from the FDA to market its Genius Digital Diagnostics System, powered by the company’s Genius Cervical AI algorithm.The digital cytology system–a medical diagnostic tool used to…
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Moderate-risk medical devices constitute 99% of those that have been regulated by the U.S. Food and Drug Administration (FDA) since it gained authority to regulate medical technology nearly five decades ago. This article presents…
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Qure.ai, a leader in medical imaging AI, achieves FDA breakthrough device status for its qSpot-TB solution, enhancing its regulatory standing alongside four FDA clearances and 61 EU MDR CE marks within 18 months. qSpot-TB,…
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According to the CDC, 42% of Americans are considered obese. There aren’t enough obesity medicine specialists to see them all. Brand medications are on the FDA shortage list and natural methods such as diet…
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DeepTek.ai has unveiled Augmento X-Ray, a pioneering CADe Chest X-Ray AI solution at RSNA23. Augmento X-Ray promises to streamline chest X-ray interpretation, reducing radiologist workload and improving patient care. Powered by US FDA Cleared…
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