FDA
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CES 2026
The Advanced Biohacking Tool Once Reserved for Elite Athletes Is Now Available to Anyone
For years, one of the most coveted tools in the biohacking and performance world wasn’t exactly a secret, but it was something only elite athletes or people in medical offices could really access. Inside NFL training rooms, NBA facilities, PGA tour environments, and elite performance centers, high-powered pulsed electromagnetic field (PEMF) therapy, a form of frequency-based technology used to support…
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Press Releases
Withings Redefines At-Home Family Healthcare in the US with FDA Clearance of BeamO
Withings, the world leader in connected health, today announced that the FDA has cleared BeamO1, the revolutionary health check-up tool. This “thermometer of the future” combines the sensors of an electrocardiogram2, a stethoscope3, and a thermometer to transform the classic thermometer into a powerful tool for the regular monitoring of heart and lung health. Clinically developed in collaboration with renowned hospitals…
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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
Empatica Achieves CE MDR Certification for EpiMonitor, Bringing Round-the-Clock Epilepsy Monitoring to Europe
Following its successful US launch and FDA clearance, Empatica is proud to announce that EpiMonitor, its pioneering epilepsy monitoring solution, is now a CE-certified device according to EU Medical Device Regulation 2017/745 and available in Europe. EpiMonitor is a game-changing, medical-grade wearable and app combination that revolutionizes epilepsy care, providing seizure detection and alerting alongside continuous health monitoring capabilities also used…
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Press Releases
First Ever Conversation Amplifying Earphones
80% of seniors with hearing loss refuse to use hearing aids because of the expense, stigma, insertion difficulties and/or challenges of hearing conversations due to hearing aids’ inability to remove background noise. Recent FDA clearance for the sale of over-the-counter hearing aids has helped make these devices more affordable but failed to overcome the other hurdles, leaving millions of seniors…
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Press Releases
Samsung’s Sleep Apnea Feature on Galaxy Watch First of Its Kind Authorized by US FDA
Samsung Electronics Co., Ltd. announced that the sleep apnea feature1 on the Samsung Health Monitor app2 has received De Novo authorization from the United States Food and Drug Administration (FDA). This feature, will detect signs of sleep apnea using a compatible Samsung Galaxy Watch and Phone, is the first of its kind to be authorized by FDA following previous approval by South Korea’s Ministry of Food and Drug…
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Press Releases
Masimo Receives FDA Clearance for Stork™ Baby Monitoring System
–Masimo (NASDAQ: MASI), a global leader in innovative monitoring technologies used in top hospitals, announced today FDA clearance of Stork™, a revolutionary baby monitoring system, for prescription use with healthy and sick babies 0-18 months of age. Leveraging the same Masimo sensor technology that monitors more than 10 million babies in hospitals every year, Stork provides continuous, accurate monitoring of a…
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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
Withings Announces US Availability of its Body Scan Connected Health Station That Records a 6-Lead ECG, Assesses Nerve Activity and Measures Segmental Body Composition
Withings, the pioneer of the connected health movement, today announced that following its recent FDA clearance, its revolutionary Body Scan Connected Health Station is now available in the US via withings.com priced at $399.95. Body Scan provides daily analysis of biomarkers associated with common health conditions. With the ability to monitor segmental body composition, heart rate, and vascular age, it further advances…
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