FDA clears AI software for reading portable MRI brain scans

An AI application that interprets MRI scans of the brain for signs or confirmation of injury has received 510(k) clearance from the FDA.

Hyperfine Research of Guilford, Connecticut, announced the development this week, saying the algorithms work with the company’s portable MRI machine called Swoop and are included in the system’s standard software setup.

The Swoop system is portable, and Hyperfine is positioning the newly approved AI capability as a way to equip clinicians at all levels of expertise with images, interpretative aids and annotations right at the bedside.

The company says the AI helps quickly deliver segmented images along with such measurements as ventricular volume, brain alignment and midline shift (a clinical measure of brain injury).

Announcement here.

Dave Pearson

Dave P. has worked in journalism, marketing and public relations for more than 30 years, frequently concentrating on hospitals, healthcare technology and Catholic communications. He has also specialized in fundraising communications, ghostwriting for CEOs of local, national and global charities, nonprofits and foundations.

Around the web

The final list also included diabetes drugs sold by Boehringer Ingelheim and Merck. The first round of drug price negotiations reduced the Medicare prices for 10 popular drugs by up to 79%. 

HHS has thought through the ways AI can and should become an integral part of healthcare, human services and public health. Last Friday—possibly just days ahead of seating a new secretary—the agency released a detailed plan for getting there from here.

Philips is recalling the software associated with its Mobile Cardiac Outpatient Telemetry devices after certain high-risk ECG events were never routed to trained cardiology technicians as intended. The issue, which lasted for two years, has been linked to more than 100 injuries.