FDA Clearance
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Press Releases
Aktiia’s Hilo Band Becomes First Cuffless Blood Pressure Monitor Cleared by FDA for Over-the-Counter Use
Aktiia, a pioneer in optical blood pressure monitoring, announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for over-the-counter (OTC) use of its cuffless blood pressure monitoring technology. This clearance, granted for Aktiia’s G0 Blood Pressure Monitoring System, marks the first time the FDA has cleared a cuffless blood pressure monitor indicated for over-the-counter (OTC) use in the United States. While Aktiia’s innovative blood…
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Press Releases
Fasikl Receives FDA Clearance for Felix NeuroAI Wristband, the First and Only AI-Powered Treatment for Essential Tremor
Fasikl, a trailblazing neuro-AI company redefining the intersection of advanced bioelectronic medicine and artificial intelligence (AI), today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the first-of-its-kind Felix™ NeuroAI™ Wristband for tremor-related functional limitations in the upper limbs in adults with essential tremor. “The Felix wristband represents a significant step forward in noninvasive, personalized…
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Press Releases
Masimo W1™ Medical Watch Receives FDA 510(k) Clearance for Over-the-Counter and Prescription Use
Masimo (NASDAQ: MASI) today announced that the Masimo W1™ medical watch has received FDA 510(k) clearance for over-the-counter (OTC) and prescription use (Rx). Masimo W1 is the first FDA-cleared watch to provide continuous real-time oxygen saturation (SpO2) and pulse rate (PR) for OTC and Rx use. The FDA clearance expands the indications for the Masimo W1 in the U.S. as a medical device…
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Press Releases
Bigfoot Biomedical Receives FDA Clearance for Bigfoot Unity® Android App for People Living with Insulin-Requiring Diabetes
Bigfoot Biomedical (Bigfoot), a leader in developing intelligent connected injection support systems, today announced the U.S. Food and Drug Administration (FDA) has issued 510(k) clearance for the Android version of the Bigfoot Unity® Mobile App, a necessary component of the Bigfoot Unity® Diabetes Management System. Given that 41 percent of U.S. smartphone users choose Android devices1, this clearance enables expanded access to a…
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Press Releases
Tidepool Announces FDA Clearance of Tidepool Loop
Tidepool, a 501(c)3 nonprofit committed to empowering the next generation of innovations in diabetes management, today announced the FDA clearance of Tidepool Loop, an automated insulin dosing app intended for the management of type 1 diabetes (T1D) in persons six years of age and greater. “We knew this day would come, but we couldn’t have achieved it without the support…
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Press Releases
Wandercraft Receives FDA Clearance for Atalante, a Self-Balancing Device for Hands-Free Movement
Wandercraft, a leading company in healthcare exoskeletons, announced today that the US Food and Drug Administration (FDA) cleared the gait-training exoskeleton, Atalante, for stroke rehabilitation. Since 2020, the French company has already deployed 22 copies of its Atalante exoskeleton in clinical settings, and 5 in other research settings. The year 2022 has seen major growth for the deep tech, with more…
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