4D Medical’s FDA Win and Pilbara Minerals’ Interim CFO MedTech and Mining Updates

3 min read | September 01, 2025 04:39 PM AEST | By Team Kalkine Media

Highlights

  • 4D Medical secures historic FDA clearance for CT:VQ lung imaging tool

  • CT:VQ offers non‑contrast, scalable lung diagnostics leveraging existing CT infrastructure

  • Pilbara Minerals appoints Flavio Garofalo as interim CFO while searching for permanent replacement

4D Medical (ASX: 4DX) achieved a landmark moment with FDA approval of its CT:VQ device, described as the world’s first CT‑based, contrast‑free ventilation‑perfusion imaging technology. The tool enables functional lung assessment—airflow and blood flow—without using radioactive tracers, making it faster and safer than conventional nuclear VQ scans. It operates on existing CT machines, thus widening access across rural and smaller healthcare settings. This technology holds promise for enhancing diagnostics of respiratory conditions like pulmonary embolism, asthma, and chronic obstructive pulmonary disease

How Is CT:VQ Positioned in the US Healthcare Market?

The CT:VQ system taps into a substantial installed base of CT scanners in the US, particularly important in regions lacking nuclear medicine infrastructure. The company sees opportunities for broader clinical deployment and is already initiating research collaborations, such as with Stanford for evaluation projects ahead of commercial rollout

Who Is Flavio Garofalo and Why Is Pilbara Minerals Appointing Him as Interim CFO?

Pilbara Minerals (ASX: PLS), a key player in lithium production, appointed its group financial controller, Flavio Garofalo, as interim chief financial officer following the departure of Luke Bortoli. Garofalo joined the company in early last year and brought over two decades of financial leadership experience, including prior roles as CFO and Company Secretary at several ASX-listed mining firms

What Is the Company Doing to Fill the Permanent CFO Role?

Pilbara Minerals has engaged global executive search firm Heidrick & Struggles to lead a formal process in appointing a permanent CFO. The company is considering both internal and external candidates to fill the role and will provide updates as the search progresses

what does this mean for Pilbara Minerals amid executive changes?

Garofalo’s interim appointment ensures continuity in financial leadership during a dynamic period for the company. His experience will support Pilbara as it navigates lithium market fluctuations and executes growth plans, while the formal recruitment process moves forward.

Entity-Rich Definitions

CT:VQ (Computed Tomography Ventilation‑Perfusion)
A non-contrast lung imaging test enabled by CT technology, providing combined functional and structural data. It offers a safer, more scalable method for assessing airflow and perfusion across lung tissues.

Interim Chief Financial Officer (Interim CFO)
An interim CFO is a temporary financial executive appointed to steer a company’s financial management during transitions. The role maintains leadership stability while the permanent position is being filled.


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