Shots:
- The US FDA has granted 510(k) clearance (K260811) to Heartvue.Proton, a machine learning-powered platform for viewing, post-processing & quantitative evaluation of cardiovascular MR images
- The platform automates 2D linear dimensions, ventricular volumes & ejection fraction, and blood flow quantification, while keeping results under physician review. It integrates with hospital PACS & EHR systems to fit existing cardiology & radiology workflows
- The clearance incl. an FDA-authorized Predetermined Change Control Plan (PCCP), allowing Heartvue to improve its AI models within predefined parameters without a new submission for every change. Heartvue.ai will now begin its US commercial rollout
Ref: Businesswire | Image: Heartvue.ai | Press Release
PharmaShots, your go-to media platform for customized news ranging across multiple indications. For more information, connect with us at connect@pharmashots.com
