What You Should Know:
– RapidAI, a pioneer in deep clinical AI, announced U.S. FDA clearance for five new imaging modules—Rapid DeltaFuse™, Rapid LMVO, Rapid MLS, Rapid OH, and Rapid Aortic for measurement.
– The expansion…
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What You Should Know:
– Ceribell, Inc. today announced that the U.S. FDA has granted 510(k) clearance for its next-generation Clarity® algorithm.
– The FDA clearance makes the Ceribell System the first and only AI-powered point-of-care…
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What You Should Know:
– GE HealthCare has announced the submission of a 510(k) to the U.S. FDA for Photonova™ Spectra, its new photon-counting computed tomography (PCCT) system with advanced AI algorithms.
– Built on proprietary…
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What You Should Know:
– The U.S. Food and Drug Administration (FDA) has recently issued several key clearances, marking significant advancements across diagnostics, surgery, and remote patient monitoring.
– These FDA clearances reflect a deepening integration…
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What You Should Know:
– HeartFocus, the revolutionary, AI-enabled cardiac imaging software developed by data-driven medtech company DESKi, today announced its U.S. commercial launch.
– HeartFocus will initially be available on Butterfly Network’s handheld ultrasound devices, the FDA-cleared…
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What You Should Know:
– Better Medicine, an AI-powered diagnostic startup for radiology, has secured nearly €6M ($6.89M) in total funding. The company recently raised €1M ($1.1M) in a pre-seed funding round led by Soulmates…
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What You Should Know:
– DeepHealth, a subsidiary of RadNet, has received FDA 510(k) clearance for its new remote scanning solution, TechLive™. The vendor-agnostic platform is designed to address the growing radiology technologist shortage by…
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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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