BioticsAI founder explains the long path to FDA clearance for AI ultrasound

In short: BioticsAI says it won FDA visibility early, earned FDA clearance in January, and is now starting to roll out its AI ultrasound tool in hospitals.

What happened

Robhy Bustami, co-founder and CEO of BioticsAI, spoke on TechCrunch’s Build Mode podcast about what it takes to build an AI product for healthcare, where rules and safety checks slow everything down.

BioticsAI is building an “AI copilot” for ultrasound. That means software that sits alongside a clinician during an ultrasound scan and helps spot possible fetal abnormalities, like a second set of eyes that does not get tired. Bustami said misdiagnosis rates in prenatal ultrasound can be higher than many people expect.

Bustami said the company designed the product with the US Food and Drug Administration (FDA) process in mind from the start. Instead of building first and worrying about approval later, the team did clinical validation early, gathered large data sets, and ran structured clinical studies before submitting to the FDA.

BioticsAI first built an early version of its product for under $100,000, which is unusual in the medical device world. That early prototype helped the company win TechCrunch Startup Battlefield in 2023. In January 2026, BioticsAI received FDA clearance, which allows it to begin launching in hospitals and grow faster.

Why it matters

AI in healthcare is not like releasing a new phone app. It is closer to getting a new airplane part approved, slow, careful, and full of checks, because mistakes can harm people. BioticsAI’s update is a reminder that when AI tools are used in medicine, the biggest challenge is often proving they work safely and reliably, not just building the software.

Source: TechCrunch AI