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FDA approval, fundraising, and the reality of building in healthcare according to BioticsAI founder

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Founders building in the healthcare space can’t just build fast and break things. Timelines stretch longer, stakes are higher, and success depends on navigating systems that reward rigor over speed. 

That’s exactly the reality Robhy Bustami, co-founder and CEO of BioticsAI, has been building in. His company is developing an AI copilot for ultrasound that helps detect fetal abnormalities, an area where misdiagnosis rates remain surprisingly high. Bustami joined Isabelle Johannessen on Build Mode to discuss how the company has navigated a highly regulated space and kept the team motivated while cutting through all the red tape.

BioticsAI started scrappy. The team built an early, functioning version of the product for under $100,000, an almost unheard-of milestone in the medical device world. That prototype helped them win TechCrunch Startup Battlefield in 2023, bringing early visibility and credibility. In January, they gained FDA approval, which means they can begin launching in hospitals and growing the business at a new rate. 

From day one, the team approached product development with FDA approval in mind. Instead of building first and figuring out regulation later, they integrated clinical validation, regulatory strategy, and product development into a single process. That meant working closely with clinicians, collecting large-scale datasets, and running structured clinical studies before ever reaching the submission stage.

The FDA process itself is often viewed as a black box, but Bustami emphasizes that founders don’t have to navigate it blindly. Early engagement with regulators, through pre-submission meetings, helped the team align on study design and expectations. Still, risk never fully disappears. For many investors, the biggest question is simple: What if the FDA says no?

Internally, those long timelines create a different kind of challenge: keeping a team motivated when the biggest milestone is years away. At BioticsAI, that meant building a culture of alignment across engineers, clinicians, and researchers, ensuring everyone got to see the wins that were happening.

 “Making sure everyone is completely aligned, even if it’s outside of their technical scope,” Bustami said, “constantly seeing wins on the R&D side,” from clinical studies to new healthcare partnerships.

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Now, with FDA clearance secured, BioticsAI is entering a new phase: deployment. The company is beginning to roll out its technology in hospitals, with plans to expand beyond obstetrics into broader areas of reproductive health.

Building in healthcare is a long game. It requires patience, discipline, and a willingness to operate in uncertainty. For founders willing to take that path, the reward isn’t just a successful company — it’s the chance to build something that genuinely changes how care is delivered.


Subscribe to Build Mode on Apple Podcasts, Spotify, or wherever you like to listen. Watch the full videos on YouTube. Isabelle Johannessen is our host. Build Mode is produced and edited by Maggie Nye. Audience Development is led by Morgan Little. And a special thanks to the Foundry and Cheddar video teams. 


Apply to Startup Battlefield: We are looking for early-stage companies that have an MVP. So nominate a founder (or yourself). Be sure to say you heard about Startup Battlefield from the Build Mode podcast. Apply here.

TechCrunch Disrupt 2026: We’re back for TechCrunch Disrupt on October 13 to 15 in San Francisco, where the Startup Battlefield 200 takes the stage. So if you want to cheer them on, or just network with thousands of founders, VCs, and tech enthusiasts, then grab your tickets.

Use code buildmode15 for 15% off any ticket type. 

When you purchase through links in our articles, we may earn a small commission. This doesn’t affect our editorial independence.

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Rescue operation ongoing for abducted Oyo pupils, teachers: Army chief

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The Chief of Army Staff (COAS), Lt.-Gen. Waidi Shaibu, says troops are making significant progress towards the rescue of 39 pupils and seven teachers abducted in Oyo.

Mr Shaibu disclosed this during an interactive session with media executives on Saturday in Port Harcourt, Rivers State, as part of activities marking the 2026 Nigerian Army Day Celebration.

The victims were abducted on May 15 from three schools in the Orire Local Government Area of Oyo.

“Operations are currently ongoing to rescue those children abducted in Oyo State, and we are making tremendous progress,” the army chief said.

He expressed confidence that the operation would lead to the safe rescue of the victims and their reunion with their families.

Mr Shaibu said the Nigerian Army remained actively engaged in various operations across the country’s six geopolitical zones to address evolving security challenges.

Speaking on operations in the North-East, he said troops under Operation Hadin Kai had recorded significant successes against insurgents and terrorists.

According to him, the operation recently neutralised a high-profile Islamic State commander, Abu-Bilal al-Minuki, in collaboration with United States partners.

“Operation Hadin Kai has neutralised over 1,872 insurgents, while many terrorists have surrendered to troops,” he said.

Mr Shaibu noted that improved security had enabled displaced persons to return to their communities, citing the recent closure of the Internally Displaced Persons camp in Bama, Borno.

In the North-West, he said Operation Fansan Yamma had continued to degrade bandit groups through the neutralisation of criminal elements and recovery of weapons.

The COAS also highlighted achievements in the North-Central region through Operations Enduring Peace, Whirl Stroke, and the newly established Operation Savannah Shield.

He said the operations had enhanced security in Plateau, Benue, Nasarawa, Kwara, Niger and parts of Kogi.

In the South-East, Mr Shaibu said the security situation had improved considerably, noting that there were no reported disruptions during the last Christmas celebrations.

“In the South-South, the nation’s oil output has improved, which is a testament to the success of operations against illegal bunkering, crude oil theft and pipeline vandalism,” he said.

The army chief described the South-West as one of the most peaceful regions, apart from the recent abduction incident in Oyo.

Mr Shaibu announced that the federal government had approved measures to strengthen military manpower to tackle emerging security threats.

He disclosed that President Bola Tinubu had approved the establishment of a new Nigerian Army depot in Amasiri-Edda, Ebonyi, bringing the number of army depots to three.

The COAS added that the depots in Zaria (Kaduna), Osogbo (Osun), and Amasiri-Edda (Ebonyi) were expected to recruit and train 28,000 young Nigerians.

“I recently directed the recruitment of 28,000 young Nigerians to enhance manpower for our various operations across the country.

“So far, the Zaria depot has graduated 6,000 soldiers, Osogbo has graduated 5,000, while Amasiri-Edda will soon graduate 3,000, bringing the total to 14,000,” he said.

Mr Shaibu added that the army had reviewed its curriculum to focus on marksmanship, counter-insurgency and counter-terrorism operations.

He said recruits now undergo about 11 months of intensive military training, including advanced infantry and acclimatisation exercises.

The COAS further disclosed that the army had acquired armoured personnel carriers, mine-resistant vehicles and unmanned aerial vehicles to strengthen operational effectiveness.

He said personnel had been deployed for specialised training both locally and abroad to ensure proficiency in operating modern military equipment.

“The acquisition of armed and surveillance drones, alongside enhanced aviation capabilities, has improved response times and operational success across theatres of operation,” he added.

Mr Shaibu reaffirmed the army’s commitment to safeguarding the nation and responding effectively to emerging security challenges.

(NAN) 

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United States will monitor Nigeria’s 2027 election — Congressman, Moore  

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A United States Congressman, Rep Riley Moore has said that the United States will closely monitor Nigeria’s 2027 general election and how the electoral process is conducted.

Moore made the remark during an interview on Noire TV on Saturday.

When asked whether he was aware of the forthcoming election in Nigeria and if there was anything the United States could do to provide political support.

Responding, the congressman said, “we will be paying close attention to Nigeria’s 2027 election.”

He added that the United States would be watching the outcome of the polls and the manner in which they are conducted.

“We are certainly going to be watching these results and how these elections will unfold and how they are executed and that something that myself and my administration will pay very close attention too,” he said.

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