article thumbnail

Hyperfine secures CE marking for Swoop portable MRI system

AuntMinnie

Connecticut-based company Hyperfine has secured CE marking under the European Medical Device Regulation for its Swoop portable brain MRI system. The company in 2023 secured initial CE certification for the Swoop system. Hyperfine said this latest approval will help position the company to launch the system broadly across Europe.

MRI 130
article thumbnail

The Rise of AI in Medical Devices: What It Means for Hiring and Innovation

MRI Network

The number of machine learning- and AI-powered medical devices approved by the U.S. In 2024, the FDA approved nearly 1,000 AI medical devices compared to just 221 in 2023. At the same time, there are concerns about whether the FDA has approved some medical devices too quickly.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

FDA issues guidance on scanning interference with implanted medical devices

AuntMinnie

Despite reported issues with CT scanning interfering with certain medical devices, the U.S. Food and Drug Administration (FDA) has said CT is still the preferred imaging modality for patients with medical devices. CT is safer than magnetic resonance imaging (MRI) for people with devices of unknown MRI safety status."

article thumbnail

CMS to make proposed MRI safety codes official

Health Imaging

The new code family was created to "capture the physician work involving patients with implanted medical devices that require access to MR diagnostic procedures."

article thumbnail

Don't get burned: Expert tips and tricks on MRI safety

AuntMinnie

How can MRI staff reduce the impact of radiofrequency-induced heating? Are tattoos and implantable medical devices safe? What are the special risks in 7-tesla MRI? System-wide vulnerabilities need to be addressed and coherent MRI safety strategies must be implemented, they added. How can quenching be avoided?

MRI 290
article thumbnail

Gleamer acquires Pixyl, Caerus Medical

AuntMinnie

AI medical imaging firm Gleamer has acquired two developers of AI-powered MRI applications, Pixyl and Caerus Medical. Pixyl is the developer of Pixyl.Neuro, which is CE-marked and has been cleared as a Class IIa medical device by the U.S. Financial and other details of the acquisitions were not disclosed.

Medical 130
article thumbnail

Imaging startup Ezra hopes to launch 15-minute, $500 whole-body MRI by 2026

Radiology Business

Food and Drug Administration clearance for its Ezra Flash, a class 2 medical device. The New York-based healthcare AI firm has scored U.S.