Skip to main content

FDA clearance 510(k)

By Jessica Hagen | 02:56 pm | September 18, 2025
The offering projects real-time 3D visuals of screw placement into a surgeon's field of view to improve accuracy in spine surgery.
By Emily Olsen | 02:35 pm | September 22, 2021
The new clearance expands its insulin dosing support to bolus and premixed insulin titration for Type 2 diabetes.
By Mallory Hackett | 03:15 pm | July 07, 2020
RapidAI, a health tech company specializing in stroke imaging, has received clearance from the FDA for its Rapid ASPECTS neuroimaging analysis device.
By Dean Koh | 04:17 am | July 02, 2020
The AI tool can now be used to triage radiology scans with intracranial bleeds, mass effect, midline shift, and cranial fractures.