- AI
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- CT
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- Ultrasound
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- Mammography
FDA Clears Updated Version of Sonio Detect Fetal Ultrasound Device
The second version of the device reportedly detects T2/T3 fetal ultrasound views with 93.7 percent sensitivity and enables 63 percent of AIUM exam protocols without manual annotation.
The Food and Drug Administration (FDA) has granted 510(k) clearance for the second version of the Sonio Detect fetal ultrasound device.
The updated Sonio Detect provides a 91.4 percent sensitivity for T1 fetal ultrasound views and a 93.7 percent sensitivity for T2 and T3 views, according to Sonio, the developer of Sonio Detect.
An upgraded version of the Sonio Detect fetal ultrasound system has garnered FDA 510(k) clearance. Key attributes of the device include 93.4 percent sensitivity and 94.9 percent specificity in detecting fetal brain structures in the second and third trimesters, according to Sonio, the developer of the device.
The company said other key benefits of the fetal ultrasound system include:
• 93.4 percent sensitivity and 94.9 percent specificity in detecting fetal brain structures in the second and third trimesters;
• 91.9 percent sensitivity and 97.6 percent specificity in detection of fetal heart structures in the second and third trimesters; and
• automated annotation for 63 percent of American Institute of Ultrasound in Medicine (AIUM) exam protocols.
“We’re excited to reach this new milestone in Sonio’s launch in the US Market,” says Cecile Brosset, the CEO of Sonio. “Alongside our adoption in multiple hospitals across the US this year, we are proud to continue successfully expanding within the US provider market with this additional clearance.”
FDA Clears AI-Powered Ultrasound Software for Cardiac Amyloidosis Detection
November 20th 2024The AI-enabled EchoGo® Amyloidosis software for echocardiography has reportedly demonstrated an 84.5 percent sensitivity rate for diagnosing cardiac amyloidosis in heart failure patients 65 years of age and older.
The Reading Room: Racial and Ethnic Minorities, Cancer Screenings, and COVID-19
November 3rd 2020In this podcast episode, Dr. Shalom Kalnicki, from Montefiore and Albert Einstein College of Medicine, discusses the disparities minority patients face with cancer screenings and what can be done to increase access during the pandemic.
