OTC
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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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CES 2019
Tivic Health Receives FDA 510(k) Clearance To Market ClearUP™ To Treat Sinus Pain Associated With Allergic Rhinitis/Hay Fever
SAN FRANCISCO, Jan. 3, 2019 /PRNewswire/ — Tivic Health Systems Inc. today announced that ClearUP Sinus Pain Relief, a first-in-class bioelectronic treatment for sinus pain due to allergic rhinitis (hay fever), has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). ClearUP is an over-the-counter (OTC) device that provides consumers with a simple, non-invasive and drug-free option to relieve sinus…
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