Justin Kozak, Executive VP at Founder Shield
Digital therapeutics (DTx) are revolutionizing healthcare — from smart inhalers to virtual therapy avatars. As more patients turn to DTx apps, companies rush to deliver innovative features. But in the race to…
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Healthcare technology company Aktiia has received FDA 510(k) clearance for its over-the-counter cuffless blood pressure monitor, G0 Blood Pressure Monitoring System, also known as the Hilo Band. Aktiia’s blood pressure system, known under the Hilo…
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Minneapolis-based Fasikl has received FDA 510(k) clearance for its Felix NeuroAI Wristband for adults with essential tremor. The wearable combines AI and neurotechnology to modulate the nervous system to help alleviate functional limitations caused by…
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What You Should Know:
– PathAI, a global leader in artificial intelligence (AI) and digital pathology solutions, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its digital…
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Sora Neuroscience, a brain AI software company, announced it received FDA clearance for its Cirrus brain mapping software, which is used for helping neurosurgeons make clinical decisions. Cirrus uses functional magnetic resonance imaging (fMRI) to generate…
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Breakthrough AI Technology Transforms Portable Brain Imaging
Hyperfine Inc., the pioneering company behind the world’s first FDA-cleared AI-powered portable MRI system, has achieved another significant milestone with FDA clearance of its groundbreaking Optive AI software….
Glucose monitoring specialist Dexcom is expanding its partnership with health-tracking ring maker Oura to provide Stelo users and ring wearers with metabolic health features, including meal insights and glucose data. Stelo provides individuals 18 and…
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Revolutionary Digital Tomosynthesis System Approved
NANO-X IMAGING LTD has achieved a significant milestone with FDA 510(k) clearance for their innovative Nanox.ARC X multi-source digital tomosynthesis system. The approval process was remarkably swift, taking less than…
Extended Wear CGM Innovation Redefines Diabetes Management
Dexcom has reached a significant milestone with FDA clearance for its G7 15-Day continuous glucose monitoring system for adults 18 and older. This next-generation device extends wear time…
TytoCare lung exam
What You Should Know:
– TytoCare, a pioneering virtual care company dedicated to delivering accessible, high-quality primary care from the comfort of home announced the company has become the first in the world…
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