FDA Cleared Patient Monitoring Sensors

FDA clears smart inhaler cap from Cognita Labs

Released on January 23, 2020

Santa Ana, California-based startup Cognita Labs has won FDA clearance for its first device, a smart cap for inhalers used by […]

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FDA Cleared Sensors Wearables

FDA Clears VivaLNK’s Wearable ECG Platform

Released on January 21, 2020

FDA has cleared VivaLNK’s continuous ECG platform. Consisting of reusable wearable ECG sensors and associated software development kit, the sensor platform gives […]

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Cardiology FDA Cleared

BioCardia Fills in a Key Piece of CardiaAmp Puzzle with New Clearance

Released on January 17, 2020

BioCardia has filled in another piece of the CardiAmp Cell Therapy puzzle with a new clearance from FDA. The San Carlos, […]

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FDA Cleared Gastroenterology Imaging

PENTAX Releases IMAGINA LED Powered Endoscopy System

Released on January 16, 2020

PENTAX is releasing its IMAGINA Endoscopy System in the U.S., having just received FDA clearance for the GI imaging platform. The […]

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AI FDA Cleared Neuro

US FDA clears Aidoc’s complete AI stroke package

Released on January 14, 2020

Aidoc has announced that the US Food and Drug Administration (FDA) has cleared its AI solution for flagging large vessel occlusion […]

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FDA Cleared Neuro Vascular

Penumbra Announces FDA Clearance of Indigo® Aspiration System for Treatment of Pulmonary Embolism

Released on January 10, 2020

ALAMEDA, Calif.–(BUSINESS WIRE)– Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, today announced U.S. Food and Drug Administration […]

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FDA Cleared Wearables

Reliefband unveils therapeutic wearables and gets expanded FDA approval for treating motion sickness

Released on January 6, 2020

Reliefband Technologies has unveiled a new line of therapeutic wearables that prevent nausea and vomiting associated with motion sickness, and it […]

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FDA Cleared Surgery

Augmedics Secures FDA Clearance for xvision, an AR Surgical Guidance System

Released on January 3, 2020

Augmedics, a Chicago-based startup developing surgical virtual reality technologies, received FDA 510k clearance for its augmented reality (AR) xvision system. xvision […]

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Cardiology FDA Cleared Ophthalmology

Masimo’s RD SET Sensors Now with Improved Accuracy for Neonates

Released on January 3, 2020

Masimo has won FDA clearance for its RD SET sensors, that feature the company’s signature Measure-through Motion and Low Perfusion SET […]

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Diagnostics FDA Cleared

Masimo’s improved pulse oximetry tech now available to all U.S. newborns

Released on January 2, 2020

Masimo (NSDQ:MASI) has won FDA clearance for pulse oximetry sensors with improved oxygen saturation accuracy specifications for newborns over 3 kg in […]

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FDA Cleared Spine Surgery

Augmedics launches its Xvision Spine AR nav system in U.S.

Released on December 26, 2019

Augmedics announced today that it won FDA 510(k) clearance for and initiated the U.S. launch of its Xvision Spine augmented reality guidance […]

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Digital Health FDA Cleared

Osia, a New Type of Implantable Hearing Solution by Cochlear, Secures FDA Clearance: Interview

Released on December 23, 2019

Earlier this month, Cochlear received FDA clearance for the Osia 2 System, the first active osseointegrated steady-state implant (OSI). The Osia […]

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