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Synchron clinical trial on Stentrode

Synchron Receives FDA Clearance To Start Clinical Trial On Wearable That Helps Paralyzed People...

Synchron, a venture-backed brain data transfer company, today announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational Device Exemption (IDE) application for its flagship product, the […]
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Dexcom Receives FDA Clearance for API Integration

Dexcom Receives FDA Clearance for its Real-Time API Integration with Third-Party Apps and Devices

DexCom, the global leader in real-time continuous glucose monitoring (CGM) for people with diabetes, announced the FDA clearance of the Dexcom Partner Web APIs, enabling invited third-party developers to integrate […]
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Natural Cycles FDA Clearance Wearables

Natural Cycles Gets FDA Clearance to Use Its Birth Control App With Wearables

For years, women have been getting help from an app called Natural Cycles to track their ovulation cycles as a form of contraception. Now, the FDA has given clearance to […]
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Nuvo Group FDA clearance for Uterine Activity

Nuvo Group’s Remote Uterine Activity Monitoring Module Gets 510(k) FDA Clearance

Remote pregnancy monitoring company Nuvo Group announced that it has received FDA clearance to add a new uterine activity module that provides capability for remote monitoring of uterine activity (UA). […]
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Masimo FDA 510(k) Clearance Radius Tº Thermometer

Masimo Receives FDA 510(k) Clearance for Prescription and OTC Use of Radius Tº Thermometer

Masimo has secured 510(k) clearance from the FDA for the prescription and over-the-counter (OTC) use of its Radius Tº wearable and wireless thermometer for patients and consumers five years and […]
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FDA eXciteOSA sleep apnea

FDA Authorizes Daytime Device to Reduce Snoring and Mild Obstructive Sleep Apnea

The U.S. Food and Drug Administration (FDA) has authorized marketing of eXciteOSA – a neuromuscular tongue stimulating device that could help prevent sleep apnea and snoring – and it doesn’t […]
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