- AI
- Molecular Imaging
- CT
- X-Ray
- Ultrasound
- MRI
- Facility Management
- 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.”
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.
Study Finds Transvaginal Ultrasound Unreliable for Detecting Endometrial Cancer in Black Patients
July 3rd 2024Utilizing a threshold of less than 5 mm of ultrasound-measured endometrial thickness, the authors of a new study noted an 11.4 percent false-negative probability for endometrial cancer in Black patients.
New Study Shows Non-Radiologists Interpreting 28 Percent of Imaging for Medicare Patients
June 28th 2024While radiologists interpreted approximately 99 percent of all non-cardiac CT, MRI and nuclear medicine studies in hospital and emergency department settings for Medicare beneficiaries, new research shows significantly less radiologist review of cardiac imaging and office-based imaging.
FDA Clears Pocket-Sized ECG System and AI Technology for Detection of Cardiac Conditions
June 27th 2024Using a reduced leadset and deep neural network algorithms trained on more than 175 million electrocardiograms, the KAI 12L technology reportedly detects up to 35 cardiac determinations, including acute myocardial infarction.
