What You Should Know: Annalise.ai, a leader in AI-powered medical imaging solutions, announced the receipt of 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the triage and notification of obstructive hydrocephalus (OHCP)…
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Welldoc®, a digital health leader revolutionizing chronic care, today announced the receipt of its 11th 510(k) clearance from the Food and Drug Administration (FDA) for its award-winning diabetes digital health solution,…
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First Light Field-Enabled Surgical Technology Company Secures Additional Institutional Capital to Drive Adoption of its AI-Driven Platform
Proprio, a Seattle-based surgical technology company, today announced that it has secured $43 million in Series B funding…
The U.S. Food and Drug Administration’s approval of Viz.ai’s hypertrophic cardiomyopathy establishes a new category for cardiovascular machine learning-based notification software.WHY IT MATTERS
Viz.ai, a disease detection and intelligent care coordination company, said in its…
What You Should Know: Movano Health, makers of the Evie Ring, the first medical-grade wearable smart ring for women announced that it has submitted a 510(k) premarket notification to the U.S. Food and Drug…
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Healthcare innovation in drug development intersects with a few critical trends: the rise of artificial intelligence (AI) applications in healthcare—particularly machine learning (ML) and predictive analytics; the need to reduce the costs associated with…
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Nesa obtains US FDA 510(k) for fibroid mapping techIndian femtech Nesa Medtech has received the United States Food and Drug Administration 510(k) clearance for its fibroid mapping tool.
Its Fibroid Mapping Reviewer Application assists in…
By Jill McKeon
July 12, 2023 – MedCrypt, a cybersecurity solution provider for medical device manufacturers, announced a partnership with Kansas State University (KSU) to drive medical device security research. MedCrypt provided a grant to KSU…
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SpassMed scores US FDA 510(k) for AI sepsis detection softwareSouth Korean medical AI company SpassMed has received the United States Food and Drug Administration’s 510(k) clearance for its AI-powered sepsis detection software.
The AI solution…
When regulators speak, we listen.
Naturally risk-averse industries like the life sciences need health authority acceptance before trying new approaches and especially before committing to wholesale operational change, even if the outcome has great potential….
