Oxitone Medical (Oxitone), an Israeli-based medical device and digital health company developing wearable monitoring solutions has received 510(k) clearance from the FDA for its wrist-sensor pulse oximetry bracelet Oxitone 1000. The wrist-sensor pulse oximeter Oxitone 1000 measures critical vital signs such as SpO2 and pulse rate with the same precision as conventional fingertip pulse oximeters.The Oxitone solution has been validated in pilot studies in a number of medical settings including
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FDA Clearance
Philips Awarded FDA Clearance for Digital Pathology Solution for Primary Diagnostic Use
Today, Philips announced it has received regulatory clearance from the FDA (via De Novo classification) for its IntelliSite Pathology Solution, marking a significant leap forward for the pathology services industry in the U.S. De novo classification is the regulatory pathway for marketing clearance for novel, low- to moderate-risk medical devices that are the first of their kindAs the first and only digital pathology system to be approved for primary diagnostic use in the country, today’s news
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