PainChek Lands Proven Medtech Chair to Lead Its Push Into the US Market
PainChek appoints Lil Bianchi as Non-Executive Chair to drive US market push
PainChek Ltd (ASX: PCK) has appointed Lil Bianchi as Non-Executive Chair of its Board, effective 25 May 2026. The appointment is timed to the company’s accelerating push into the US market, following FDA De Novo clearance and access to US Centers for Medicare and Medicaid Services (CMS) reimbursement. Incumbent Chair John Murray transitions to a Non-Executive Director role, remaining on the Board as the company enters what management describes as a key international growth phase.
When big ASX news breaks, our subscribers know first
Who is Lil Bianchi?
Ms Bianchi brings a career spanning global corporates, technology start-ups, and initial public offering (IPO) environments, with particular depth in scaling medical technology companies into international markets. Her credentials are directly aligned with PainChek’s current stage of growth.
Key highlights from her professional profile include:
- Chair of 4DMedical (ASX: 4DX): A global leader in respiratory imaging that has grown from its IPO in 2020 to a $2 billion+ market capitalisation and entry to the ASX200 in 2026, achieving major regulatory clearances globally and building a US customer base that includes some of the world’s most renowned medical institutions
- Non-Executive Director of Qscan Radiology Group: Founded in 2006, Qscan has expanded to more than 80 clinics focused on diagnostic medical imaging and interventional procedures across five Australian states
- Expertise spanning business transformation, AI and SaaS technologies, governance, capital markets, and international commercialisation
- Background across global corporates, tech start-ups, and IPO environments, with board, CEO, and senior executive leadership experience
Her 4DMedical track record is particularly relevant to investors. That appointment saw Ms Bianchi guide a medtech company through US market entry, major regulatory clearances, and sustained growth to ASX200 inclusion. PainChek is now at a comparable inflection point.
Lil Bianchi, Incoming Non-Executive Chair
“I am absolutely delighted to be appointed Chair of PainChek at this exciting moment in the Company’s journey. PainChek is well positioned as the world’s first FDA-cleared medical device for pain assessment. I look forward to joining the team and bringing my additional experience and capability to support PainChek’s global expansion at this key inflection point, as we accelerate access into the large US market with our groundbreaking medical device that has immediate access to US CMS reimbursement. I want to take this opportunity to thank John Murray, who has Chaired the Company through listing on the ASX, development of a first commercial product and establishment in the Australian, UK and North American markets.”
Why this appointment matters for PainChek’s US strategy
The US opportunity PainChek is now pursuing
FDA De Novo clearance is a regulatory pathway granted by the US Food and Drug Administration (FDA) for novel, low-to-moderate risk medical devices that have no legally equivalent predicate already on the market. For PainChek, this classification confirms the safety and effectiveness of its AI-powered pain assessment technology for the US healthcare system. Paired with access to US CMS reimbursement, which means US healthcare providers can be paid back by the federal government’s Medicare and Medicaid programmes for using the device, the commercial pathway into the world’s largest healthcare market is now open.
PainChek already holds regulatory clearance across a substantial global footprint, with the US representing the most recent and commercially significant addition.
| Market | Regulatory Status | Key Milestone |
|---|---|---|
| Australia | TGA-cleared | First regulatory clearance; origin market |
| United Kingdom | Cleared | Established commercial presence |
| Canada | Cleared | Regulatory approved medical device |
| European Union | Cleared | Regulatory approved medical device |
| New Zealand | Cleared | Regulatory approved medical device |
| Singapore | Cleared | Regulatory approved medical device |
| Malaysia | Cleared | Regulatory approved medical device |
| United States | FDA De Novo cleared | Most recent clearance; CMS reimbursement access secured |
What Bianchi’s appointment signals
The board restructure reflects PainChek’s transition from a company establishing its platform to one positioned to scale it internationally. Ms Bianchi’s appointment is a deliberate move to bring in leadership with demonstrated experience in precisely this type of commercial expansion.
The company enters this phase with substantial existing traction: contracts with over 2,000 aged care facilities and more than 20,000,000 digital pain assessments conducted globally. That commercial foundation, combined with US FDA clearance and CMS reimbursement access, positions the company to pursue a significantly larger addressable market.
John Murray, Outgoing Chair and Incoming Non-Executive Director
“After an extensive search, we are delighted to be able to announce the appointment of someone of the calibre of Lil Bianchi to Chair the Company for the next stage of its international growth. Lil has excellent skills and proven experience of growing medtech in international markets, and in particular penetrating the North American market. I look forward to working with Lil as a Non-Executive Director.”
The next major ASX story will hit our subscribers first
Looking ahead: PainChek’s growth trajectory
The appointment points to a clear set of near-term strategic priorities for the company:
- Accelerating US market penetration by leveraging FDA De Novo clearance and CMS reimbursement access to drive adoption among US healthcare providers
- Scaling internationally under new Chair leadership with proven medtech growth experience across the US and European markets
- Continued expansion of the global customer base beyond the existing 2,000+ aged care facility contracts
PainChek enters this phase as the world’s first FDA-cleared medical device for pain assessment, with a Chair who has previously navigated comparable medtech growth cycles at the international level. The combination of first-mover regulatory positioning and experienced board leadership represents the company’s core proposition to investors as it pursues the US market opportunity.
Don’t Miss the Next Healthcare Breakout
Big News Blast delivers FREE breaking ASX healthcare news directly to your inbox within minutes of release, complete with in-depth analysis already done for you. Over 20,000+ subscribers rely on it to stay ahead of market-moving announcements. Click the “Free Alerts” button at StockWire X to start receiving alerts the moment news breaks.