Cape Town‑based AI Diagnostics has secured R85 million in a pre‑Series A round, earmarked for scaling its AI‑enhanced digital stethoscope that screens for tuberculosis (TB) through real‑time lung‑sound analysis. The funding, led by The Steele Foundation for Hope, also saw participation from the iFSP Group, the Global Innovation Fund, and returning investors such as Africa Health Ventures and Savant. Management says the capital will fast‑track clinical validation, hardware refinement, and the rollout of operational infrastructure across sub‑Saharan Africa and select Asian markets.
Founded in 2020, the startup introduced the Ostium digital stethoscope, paired with a proprietary AI engine called AI.TB. Unlike traditional stethoscopes, the device can be operated by community health workers, nurses or pharmacists, instantly flagging patients whose acoustic signatures suggest a TB infection. Those flagged are then referred for confirmatory testing, dramatically shortening the pathway from suspicion to diagnosis.
The South African Health Products Regulatory Authority has already granted approval for the device, and the company reports having screened more than a thousand South Africans to date. Ongoing clinical trials now span over ten countries across Africa and Asia, aiming to prove the model’s accuracy in diverse epidemiological settings.
TB burden
South Africa remains one of the world’s TB hotspots. According to the World Health Organization’s 2025 Global TB Report, the nation recorded 249 000 new TB cases in 2024, with an estimated 54 000 deaths. A national prevalence survey cited by AI Diagnostics revealed that 58 % of individuals testing positive for TB were asymptomatic, underscoring the shortcomings of symptom‑based screening. Moreover, more than half of TB cases in southern Africa occur in people living with HIV, compounding diagnostic challenges.
“The AI model flags individuals whose lung sounds have signals associated with TB in real time so healthcare providers can refer them for diagnostic testing immediately,” explained CEO Braden van Breda. He added that the technology could reshape screening by bringing reliable detection to remote clinics lacking X‑ray equipment or specialist physicians.
Lead investor Joe Exner, CEO of The Steele Foundation for Hope, praised the hardware as “a breakthrough that places genuine diagnostic capability in the hands of nurses and community health workers.” He highlighted the device’s potential to bridge gaps where conventional radiography is unavailable.
Industry observers note that the stethoscope has changed little since its invention over a century ago. Rowena Luk, managing partner at Africa Health Ventures, believes AI Diagnostics could spearhead the next evolution of the instrument, turning a ubiquitous tool into a smart, data‑driven diagnostic ally.
Van Breda emphasized that the new capital signals a shift in investor mindset: “Global health is increasingly viewed as a commercial opportunity, not merely a philanthropic cause.” He urged that TB has historically suffered from under‑funding relative to its impact, especially in low‑ and middle‑income regions.
Despite the promising outlook, the company withheld details on its post‑money valuation, cumulative fundraising totals, and specific unit economics. Likewise, it has not released the sensitivity and specificity metrics of the AI model compared with standard sputum testing or AI‑assisted chest X‑ray, leaving some clinical questions open.
Nonetheless, the infusion of R85 million equips AI Diagnostics to accelerate product development, expand clinical trials, and begin large‑scale deployments. If the AI‑driven stethoscope lives up to its early performance data, it could markedly narrow the detection gap that has long plagued TB control programs, saving lives across some of the world’s most vulnerable communities.