BioticsAI, the 2023 TechCrunch Disrupt Battlefield winner, announced Monday it has secured FDA clearance for its artificial intelligence software designed to detect fetal abnormalities in ultrasound images.

Founded in 2021 by CEO Robhy Bustami alongside Salman Khan, Chaskin Saroff, and Dr. Hisham Elgammal, the company addresses a critical healthcare challenge: there is a global shortage of maternity care professionals (midwives and obstetricians). The effects of this shortage are especially noticeable in the U.S., where a recent report found that almost 50% of U.S. counties has no registered obstetricians, midwifes, L&D nurses or even proper birthing units. This shortage places an additional burden on patients (especially Black women) and existing staff alike, and makes it much more likely for abnormalities to go undiagnosed.

BioticsAI's software helps mitigate omissions and optimizes healthcare workers' workflows in several points. First, the software integrates with existing imaging devices and picture archiving and communication systems to ensure that fetal ultrasounds are not left incomplete. Then, once the imaging is complete, the software reviews the scans to check that the fetus has been appropriately captured from all angles in accordance with international standards. Then, the AI-powered component of the software helps detect any abnormalities that may be present in the scans, and automates the reporting process by extracting any relevant insights present in the imaging.

According to Bustami, whose family background in obstetrics inspired the venture, the most challenging aspect wasn't developing the AI models but ensuring reliable real-world performance across all patient demographics, especially high-risk populations. The company has been building an impressive dataset of prenatal ultrasound images, and is always on the lookout for partnerships that help it obtain more data to increase its algorithm's accuracy. Currently, BioticsAI claims its abnormality detection algorithm is 96% accurate.

With clearance now secured, BioticsAI plans to scale across healthcare systems nationwide. While its AI-component is currently focused on second trimester scans, since those are the ones used for most fetal abnormality screenings, the startup does not rule out expanding its AI-powered diagnostics tools to adjacent fields related to reproductive health and post-natal medical care.