What You Should Know:
– Axena Health, a medical device company focused on female pelvic health, announced a collaboration with Mayo Clinic to integrate educational content on overactive bladder (OAB) into its clinically proven Leva®…
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Breakthrough in Women’s Healthcare Technology
GE HealthCare has achieved a significant milestone with FDA 510(k) clearance for their updated Voluson Expert Series ultrasound systems. The series, comprising Voluson Expert 22, 20, and 18, represents a…
Groundbreaking AI Technology Receives FDA Approval
RapidAI has achieved a significant milestone with FDA 510(k) clearance for their revolutionary Lumina 3D system. This automated 3D imaging reconstruction solution leverages cutting-edge AI technology to replace traditional…
Welcome to the January edition of Digital Health Digest, your trusted source for the latest in digital health and healthcare technology!In this episode, we cover major updates transforming the digital health landscape—from Bicycle Health…
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Welcome to our deep dive into the digital health trends that are set to revolutionize healthcare in 2025!In this video, we explore the cutting-edge developments and emerging technologies that promise to redefine how care…
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AI Optics, an AI-enabled medical device company, has received FDA 510(k) clearance for its Sentinel Camera.The handheld retinal imaging system captures high-quality images of the human eye, helping to address gaps in retinal disease…
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Margaret Nardini, Healthcare Product Manager at Accruent
The complexity and cost of medical devices are escalating, and with it, the stakes for maintaining these assets efficiently and compliantly are increasing. In some cases, this requires…
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What You Should Know:
– GE HealthCare has received 510(k) clearance from the United States Food and Drug Administration (FDA) for its updated portfolio of Voluson™ Expert Series ultrasound systems.
– The Voluson Expert 22, 20,…
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Hong Kong-based startup PanopticAI has obtained regulatory approval in the United States for its contactless pulse rate measuring application. It received the US Food and Drug Administration’s 510(k) clearance for the PanopticAI Vital Signs app…
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Joseph M. Saunders, Founder and CEO, RunSafe Security
Medical device manufacturers face a conundrum. To meet recent FDA requirements, which were initially introduced a little over a year ago, they now need to quickly provide…
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