What You Should Know:
– Proprio has secured FDA clearance for Picasso, its fourth cleared capability within the Paradigm AI surgical platform.
– The feature enables “trace-based” optical registration, allowing spine surgeons to perform real-time, radiation-free…
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What You Should Know
– AliveCor, the global leader in AI-powered cardiology, has received U.S. FDA clearance for the next generation of its KAI 12L AI. This update expands the diagnostic breadth of the Kardia…
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What You Should Know
– AccurKardia has announced its second FDA 510(k) clearance for the AccurECG™ Analysis System (v2.0). This enterprise-grade, cloud-based platform is designed to ingest data from any ECG hardware—including patches and Holters—and…
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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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