FDA clears Time Medical's MRI

Time Medical has received FDA approval for its Pica 0.35T whole-body open MRI system.

The Metuchen, N.J.-based company said its Pica features a 0.35T compact, permanent magnet with a gradient strength of 25 mT/m, a gradient slew rate of 50 T/m/s and a gradient rise time of 0.5 ms. The firm said the system also features openGL based visualization with auto window/Level, move, zoom, multiple image display, annotate, measurements, multi-planar reformat, real-time MIP, CINE, multiple viewport and cross-exam review.

Around the web

As debate simmers over how best to regulate AI, experts continue to offer guidance on where to start, how to proceed and what to emphasize. A new resource models its recommendations on what its authors call the “SETO Loop.”

FDA Commissioner Robert Califf, MD, said the clinical community needs to combat health misinformation at a grassroots level. He warned that patients are immersed in a "sea of misinformation without a compass."

With generative AI coming into its own, AI regulators must avoid relying too much on principles of risk management—and not enough on those of uncertainty management.

Trimed Popup
Trimed Popup