BlinkLab Sets Q1 2026 for Pivotal FDA Autism Diagnostic Trial with New MD

Leadership Shift Reflects Strategic Growth

BlinkLab Limited, an Australian digital health innovator focused on neurodevelopmental diagnostics, has announced a significant leadership change with the appointment of Dr Henk-Jan Boele as Managing Director. Dr Boele, who co-founded the company and has served as CEO since its inception, will now take on expanded responsibilities to guide BlinkLab through its pivotal FDA 510(k) regulatory trial for its BlinkLab Dx 1 autism diagnostic technology.

This leadership evolution comes as the company prepares to commence the main study of its FDA trial in the first quarter of 2026, marking a critical milestone in its journey toward early commercialisation. The Board’s decision to elevate Dr Boele underscores the need for clear strategic alignment and operational focus amid increasing clinical and regulatory complexities.

Progress and Milestones Pave the Way

Under Dr Boele’s stewardship, BlinkLab has achieved several foundational milestones that have de-risked its regulatory pathway. Notably, the company completed a successful pilot study that delivered positive results, bolstering confidence in its technology. Additionally, BlinkLab has established a network of leading U.S. clinical sites, including top autism research centers, to support its upcoming FDA trial.

The company’s capacity to manage multiple complex research programs across various neurodevelopmental conditions and international jurisdictions further highlights its operational maturity. This includes ongoing work targeting ADHD and dementia, alongside autism, positioning BlinkLab as a versatile player in digital health diagnostics.

Board Changes Signal New Phase

Alongside Dr Boele’s appointment, BlinkLab announced the resignation of Non-Executive Director Jane Morgan, effective immediately. Ms Morgan played a pivotal role in guiding the company through its IPO and early ASX listing phases, helping to establish BlinkLab’s profile within the Australian capital markets. Her departure marks a natural transition as the company moves from early development toward regulatory and commercial execution.

Both Dr Boele and Ms Morgan expressed mutual respect and optimism for BlinkLab’s future, with Ms Morgan reaffirming her support as a shareholder and advocate. The Board expressed gratitude for her contributions and wished her success in her future endeavors.

Looking Ahead

As BlinkLab prepares to launch its pivotal FDA 510(k) trial in early 2026, the company’s leadership and board changes reflect a sharpened focus on navigating the regulatory landscape and accelerating commercial readiness. The appointment of Dr Boele as Managing Director ensures continuity and clarity of accountability at a critical juncture, while the company’s recent capital raising and clinical progress provide a solid foundation for growth.

Investors and observers will be watching closely as BlinkLab advances its technology toward market entry, potentially transforming early autism diagnosis through smartphone-based AI and machine learning innovations.