Medtech company gains FDA clearance for automated echocardiography software

Medical technology company has gained federal clearance for its automated decision support system used during echocardiography exams, the firm announced Tuesday.

The U.S. Food and Drug Administration granted clearance to the image analysis software known as Us2.v1. The Singapore-based company says its patented solution recognizes and analyzes 2D and doppler echo images, automating measurements required to diagnose heart conditions.

"With this … we’ve moved the field of AI beyond just a narrow feature for echocardiography, to a complete decision support solution for cardiologists and primary care providers,” CEO and Co-founder of the firm James Hare said in a statement.

Brigham and Women’s Hospital performed a validation study following multiple trials with pharmaceutical partners, such as AstraZeneca. Fully automated measurements were reproducible with processing times approaching nearly 2 minutes per exam, according to the announcement.

The team hopes doctors using its tool can more quickly diagnose a variety of heart conditions, including pulmonary hypertension and heart failure. 

“AstraZeneca is excited to partner with because we believe it has the potential to transform the management of heart failure, bringing early access to echocardiography, including expert-level analyses, to primary care settings, the general community and even to patients’ home,” said Joris Silon, senior vice president of the Cambridge, U.K.-based firm’s BioPharmaceuticals Business Unit.

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