Up more than 800% in a year. Why this ASX medical tech stock just hit an all-time high

4DMedical shares have surged over 800% as US hospital adoption and FDA clearance drive momentum.

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The meteoric rise of 4DMedical Ltd (ASX: 4DX) has grabbed the attention of ASX investors this year. On Friday, the stock closed up 12.14% at $5.08, marking not only a strong weekly finish but also a fresh all-time high for the respiratory imaging specialist.

Over the past 12 months, 4DX shares have surged an astonishing 815%, putting it among the best-performing stocks on the ASX.

So, what's driving this extraordinary rally, and can the momentum continue?

Let's take a closer look.

What does 4DMedical do?

4DMedical is a healthcare technology company focused on advanced respiratory imaging.

Its flagship product, CT:VQ, uses software to convert standard CT scans into detailed functional lung images. This allows clinicians to assess lung ventilation and blood flow without radioactive tracers, offering a faster and less invasive alternative to traditional nuclear medicine scans.

The technology is designed to help diagnose and monitor conditions such as pulmonary embolism, chronic obstructive pulmonary disease, and other respiratory illnesses.

US adoption gathering pace

One of the biggest catalysts for the share price this year has been accelerating adoption in the United States.

Earlier this month, 4DMedical announced that UC San Diego Health had begun clinical adoption of CT:VQ. This followed earlier uptake by major institutions, including Stanford University, the Cleveland Clinic, and the University of Miami.

These high-profile academic centres are seen as important reference sites. Their adoption helps validate the technology and supports broader rollout across hospital networks.

The company has structured its early deployments under launch agreements, with a pathway toward full commercial contracts over time.

$150 million placement strengthens balance sheet

Adding further momentum, 4DMedical recently completed a $150 million institutional placement.

The capital raise strengthens the balance sheet and provides funding to accelerate US commercialisation, expand sales capability, and support ongoing product development.

While the placement results in dilution for existing shareholders, the market response suggests investors view the funding as an important step to support long-term growth.

What are the risks?

Despite the strong share price performance, the risks remain.

4DMedical is still in the early stages of commercialisation and is not yet profitable. So, execution will be critical, particularly in converting pilot and launch sites into recurring revenue contracts.

The valuation has also risen sharply to around $2.7 billion, meaning expectations are now very high.

Foolish Takeaway

4DMedical's rise has been nothing short of remarkable.

With FDA clearance, growing US adoption, and a well-funded expansion plan, the company has strong momentum behind it.

However, after an 800% rally in just 12 months, investors should expect volatility and keep a close eye on execution as the next phase of growth unfolds.

Motley Fool contributor Aaron Teboneras has no position in any of the stocks mentioned. The Motley Fool Australia's parent company Motley Fool Holdings Inc. has no position in any of the stocks mentioned. The Motley Fool Australia has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips.

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