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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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NCC seek stronger cyber resilience as AI intensifies cyber threats

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The Nigerian Communications Commission (NCC) has called for stronger collaboration, improved digital security infrastructure and effective policies to address emerging cyber threats driven by Artificial Intelligence (AI).

Dr Aminu Maida, Executive Vice-Chairman of the NCC, made the call at the second edition of the International Cybersecurity Conference (ICSC), held on Tuesday in Abuja.

The theme of the conference was, “Cyber Resilience in the Age of AI: Defending Minds, Networks and Nation”.

Maida said AI had significantly increased the sophistication, speed and scale of cyberattacks, making cybersecurity a national imperative.

He said telecommunications infrastructure had become central to Nigeria’s digital economy, supporting financial transactions, communications, public services and business operations, thereby making its protection critical to national security.

He said cyber resilience went beyond preventing attacks to developing the capacity to anticipate, withstand and recover from disruptions while ensuring the continuity of essential services and economic activities.

According to him, emerging threats include AI-driven phishing, automated credential attacks, deepfakes designed to bypass authentication systems and malware capable of modifying itself to evade detection.

“The recent international cybersecurity incidents involving attacks on supermarket refrigeration systems in France and spyware targeting journalists and media personnel in the Middle East underscore the need for stronger digital defences.

“Section 4 of the Nigerian Communications Act, 2003, mandates the commission to protect consumer rights, safeguard national interests and promote the safety and efficiency of communications infrastructure.

“We have established the NCC Computer Security Incident Response Team (NCC-CSIRT) to monitor threats, facilitate intelligence sharing and coordinate responses to cybersecurity incidents across the telecommunications sector,” he said.

Maida said that the commission’s cyber resilience framework for the Nigerian communications sector provided common security standards for licensed operators and strengthened coordination with the national Computer Emergency Response Team, (ngCERT).

“There are three critical areas for strengthening cyber resilience. They include protecting human minds through cybersecurity awareness.

“There is also securing networks through robust security architecture, and defending the nation through collaboration among regulators, telecommunications operators, financial institutions and security agencies,” he said.

He urged telecommunications operators to adopt Zero Trust Architecture, which requires continuous verification of users and systems, while ensuring that AI models integrated into network operations were regularly assessed for vulnerabilities.

The National Security Adviser (NSA), Malam Nuhu Ribadu, said that digital development and national security could no longer be treated as separate priorities.

Ribadu was represented by Prof. Gerald Ilukwe from the Office of the National Security Adviser (ONSA) .

He said that AI presented opportunities for strengthening cyber defences but could also enable criminals to develop sophisticated scams, clone voices and spread false information.

He urged Nigerians to verify identities and authenticate suspicious requests before taking action.

“There is a need to secure digital supply chains, including AI models, data services and third-party technology providers.

“Vulnerabilities within one organisation can compromise other institutions and critical national infrastructure.

Ribadu said that the ONSA, through the National Cyber Security Coordination Centre, was strengthening coordination among relevant institutions and providing tools, laboratories and cyber ranges to analyse threats, investigate incidents and test response capabilities.

He said that a review of the National Cybersecurity Policy and Strategy, last updated in 2021, was underway to address emerging challenges, including AI-enabled fraud, supply-chain vulnerabilities, workforce development and international cooperation

“Recommendations from the conference will contribute to the ongoing review. The revised strategy will establish measurable priorities, promote accountability and strengthen the country’s capacity to respond to cyber incidents,” he said.

Rep. Ayodeji Stanley, Chairman, House of Representatives Committee on ICT and Cybersecurity, described cybersecurity as a moving target that required continuous innovation, adaptable legislation and international cooperation.

Stanley drew on his experience working on complex information technology systems in the United States.

He said the transition from traditional computing to cloud technologies had introduced new security challenges, requiring continuous improvements in protection mechanisms.

He urged policymakers, security experts and technology practitioners to develop forward-looking solutions that would protect critical systems across sectors, including food security.

Stanley said that cyberattacks could have consequences beyond the disruption of digital services.

He called for a collective global response to cyber threats, saying countries must work together to develop effective policies and innovative approaches capable of addressing the rapidly changing cybersecurity landscape.

(NAN)

The post NCC seek stronger cyber resilience as AI intensifies cyber threats appeared first on Business Today NG.

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Upwind raises $400M after walking away from Datadog acquisition offer

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Upwind, a San Francisco startup that uses AI to secure cloud infrastructure, has raised a $400 million Series C round at a $3.8 billion valuation led by Bessemer Venture Partners, with participation from existing backers including Greylock Partners and Craft Ventures.

The round comes nine months after Upwind closed its previous $250 million financing at a $1.5 billion valuation.

The fresh funding, which has been in the works for months, nearly fell apart after Datadog attempted to buy the company, according to a person familiar with Upwind. Datadog is a publicly traded company that sells tools for monitoring how software runs, known as observability. It didn’t offer a premium above the $3.8 billion valuation set by venture capital investors, the person said, so Upwind decided to stay independent.

Four-year-old Upwind has grown rapidly amid rising AI-driven cybersecurity threats. The startup has been adding $20 million to $30 million in annualized recurring revenue (ARR) each quarter and is projected to end the year at roughly $90 million, according to a person familiar with Upwind’s financials. That means that VCs and Datadog valued the startup at more than 40 times its forecast ARR, a common yardstick for pricing software companies. The high multiple is also well below the 80x ARR fetched by Cyera, another fast-growing cybersecurity startup, according to TechCrunch reporting from earlier this year.

Cybersecurity is poised to be the third big wave of AI software that companies will pay for after AI coding tools and customer support, Theory Ventures general partner Tomasz Tunguz recently wrote in his widely read blog.

By walking away from an acquisition offer, Upwind clearly believes that the company will ultimately be worth more than the $3.8 billion that Datadog was ready to pay for it. However, given how few cybersecurity companies have gone public in recent years, an eventual sale remains the most likely outcome for the startup.

Upwind continues to draw acquisition interest, according to a person familiar with the company.

The startup was founded by Amiram Shachar, who sold his previous company, the cloud spend management startup Spot.io, to NetApp for $450 million. Upwind calls its approach to thwarting threats “runtime” security, which means it alerts and remedies attacks and vulnerabilities in active services in real time.

TechCrunch has reached out to both Upwind and Datadog for comment.

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