Health receives FDA certificate for algorithm related to pulmonary embolism

AI-powered imaging and care coordination company received FDA 510(k) certification for an algorithm that can help determine the severity of a pulmonary embolism.

Startup received the green light of the agency end of last month for the RV/LV ratio algorithm, measures the ventricular diameter of the heart to provide the maximum right ventricular to left ventricular diameter ratio. Determine the possible rate help identify right ventricular dysfunction in the heartThat could be a sign of poor results.

“With this clearance, the Viz PE Solution now includes both,” said Dr Kenneth Rosenfield, head of interventional and vascular medicine at Massachusetts General Hospital and co-founder of the PERT Consortium. detection of blood clots in the lungs and stress levels in the right heart. , said in a statement. is a sponsor of the PERT Consortium, which focuses on pulmonary embolism research and care.

“This will enable clinicians to rapidly triage patients and provide appropriate treatment, by providing a powerful tool for early detection and risk stratification. Rapid critical decision-making This will definitely save lives.”


This payment marks’s third 510(k) so far this year. At the end of July, it announced Viz Subdural had been removed to flag potential cases of subdural haemorrhage. It also received 510(k) in February for an algorithm designed to detect brain aneurysms.

The most recent raised $100 million Series DI round that raised its valuation to $1.2 billion. When the round was announced in April, the company said it would use the capital to drive growth and add new classification capabilities to its platform. Founded in 2016, has raised over $250 million in venture capital.

There are a number of companies focused on using AI to detect and categorize potential health concerns based on image results. Earlier this summer, Aidoc raised $110 million in Series EAS funding round to further expand its platform, to include AI tools and care coordination software. It recently received FDA license 510(k) for tools to find and classify potential brain aneurysm and pneumothoraxor atelectasis.

In May, RapidAI get clearance for its own pulmonary embolism-focused tool. Other companies in the AI ​​imaging space include Gleamer, Nanox and

Source link


News5h: Update the world's latest breaking news online of the day, breaking news, politics, society today, international mainstream news .Updated news 24/7: Entertainment, the World everyday world. Hot news, images, video clips that are updated quickly and reliably

Related Articles

Back to top button