MassDevice12d
FDA clears AI 3D head, neck imaging tech from RapidAI
RapidAI announced that it received FDA 510(k) clearance for its Lumina 3D automated 3D imaging reconstruction solution.
Miamisburg-based Riverain Technologies receives FDA clearance for AI-powered imaging software
A Dayton-area medical technology firm has recently had its AI-driven image processing and analysis technology cleared by the ...
Healio12d
FDA grants 510(k) clearance to AI Optics’ handheld retinal imaging system
The FDA has granted 510(k) clearance to AI Optics’ Sentinel Camera, a handheld retinal imaging system that captures ...
Ibex Medical Analytics Receives First FDA 510(k) Clearance
Ibex Medical Analytics (Ibex), the leader in AI-powered cancer diagnostics, today announced that it has received U.S. Food ...
FDA Approval Race: AI-Powered Innovations Reshape the Healthcare Landscape
Beyond Stargate's big players, a growing number of innovators have been revolutionizing healthcare by making recent ...
Business Wire7d
Ibex Medical Analytics Receives First FDA 510(k) Clearance
BOSTON--(BUSINESS WIRE)--Ibex Medical Analytics (Ibex), the leader in AI-powered cancer diagnostics, today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance ...
TMCnet6d
Neuvotion Receives FDA Clearance for NeuStim™ Providing Non-Invasive, High-Resolution Stimulation for the Hand After Stroke or Spinal Cord Injury
Neuvotion has received FDA 510(k) clearance for their first product, NeuStim™, a non-invasive, surgery-free wearable that ...
MassDevice6d
Neuvotion wins FDA nod for neuromod wearable
Neuvotion announced today that it received FDA 510(k) clearance for its first product, the NeuStim wearable device.
Morningstar6d
FDA Approval Race: AI-Powered Innovations Reshape the Healthcare Landscape
Spectral AI's DeepView® System is a predictive medical device and associated software ... also recently announced that it received 510(k) clearance from the FDA for the updated portfolio of ...
Fierce Healthcare11d
How Eko Health is reinventing the stethoscope, aiming to change early detection of heart and lung disease
The digital health company gave a centuries-old device—the stethoscope ... Last April, the Food and Drug Administration cleared Eko's AI algorithm that captures cases of low cardiac ejection ...