Viz.ai gets FDA De Novo approval for AI-enabled heart disease detection

The US FDA has authorised Viz.ai to aid the diagnosis of hypertrophic cardiomyopathy (HCM) with its machine learning-based software. By rapidly scanning images, the software can detect the disease earlier. HCM, which affects one million people in the US but is only diagnosed in 20% of cases, is particularly dangerous as it can lead to sudden cardiac death. Using the software will enable quicker referrals to the correct specialists and better co-ordinated treatment and follow-up.