The 4DMedical Ltd (ASX: 4DX) share price is $3.95, down 1.5% today, but up a staggering 1,173% over 12 months.
This ASX 200 healthcare share is a major outlier in a sector that has been struggling big-time for many months.
In fact, healthcare has been the worst performer of the 11 ASX 200 market sectors over the past year, down 39%.
So, why are 4DMedical shares bucking the trend?
Image source: Getty Images
4DMedical shares shooting the lights out
4DMedical shares have ripped higher as the respiratory imaging technology company takes big strides in its growth.
Samy Sriram, a market analyst at online investment platform, Stake, sums it up:
Its performance is built on a series of catalysts, each of which is the opposite of what's hurting its peers.
ASX 200 healthcare companies are facing many headwinds today.
Sriram cites currency challenges for companies reporting in US dollars, and the likelihood of further interest rate rises in Australia.
Cost-of-living pressures in Australia and worldwide are also prompting people to delay treatments, such as surgeries.
Higher shipping costs due to the Iran war, new caps on insurance payouts in some nations, and higher staff wages are also having an impact.
However, 4DMedical has cleared one of the biggest hurdles for ASX biotechs today: regulatory uncertainty in the world's biggest market, the United States.
Amid leadership changes at the US Food and Drug Administration (FDA), there are also conflicting signals on future approval standards.
A US rare diseases advocacy organisation says uncertainty has become so great that biotechs are finding it difficult to raise funding.
Sriram said:
While other ASX healthcare stocks are being hammered by FDA uncertainty under Trump, 4DX had already cleared the hurdle.
In September 2025, 4DMedical received FDA 510(k) clearance for its CT:VQ platform.
4DX also secured a one-year contract with GlaxoSmithKline (LSE: GSK), starting in May 2026, to provide lung imaging biomarkers for pharmaceutical clinical trials.
What is CT:VQ?
4DMedical describes CT:VQ as the world's first non‑contrast post‑processing technology that transforms routine chest CTs into quantitative, lobar ventilation and perfusion maps without the need for patients to be injected with contrast agents or radioisotopes.
It's a software-as-a-service (SaaS) system compatible with the 14,500 CT scanners already installed across the US.
Sriram said 4DMedical shares are bucking the trend because the company is in a different stage of its regulatory and commercial journey than its healthcare sector peers.
She said:
The headwinds hammering CSL Ltd (ASX: CSL), Cochlear Ltd (ASX: COH) and ResMed CDI (ASX: RMD) don't apply to a company that cracked the US market open from scratch.
It's a pure growth story in a sector that's otherwise in a value reset.
Last month, 4DMedical announced several other regulatory approvals, including certification for CT:VQ in the United Kingdom.
The company said:
UK clearance opens access to one of the world's most developed diagnostic imaging markets, with millions of chest CT scans performed annually across respiratory, oncology and acute care pathways.
Should you buy 4DMedical shares?
This ASX 200 healthcare share sure is popular with Aussie investors.
Over the past 30 days, 4DMedical shares were the most traded ASX 200 healthcare stock on Stake, and 70% of orders were buys.
There is a consensus hold rating among three analysts on the CommSec trading platform today.
Stuart Bromley from Medallion Financial Group also has a hold rating on 4DMedical shares.
Bromley noted that 4DMedical has a strong regulatory moat in the US, and commented (courtesy The Bull):
In a relatively short time since the US Food and Drug Administration approved its CT:VQ product, US hospitals are adopting it, including the highly renowned Mayo Clinic.
Also, 4DX has been included in the S&P/ASX200 Index, which should generate more interest in the company.
4DMedical shares ascended into the ASX 200 on 20 April in place of Insignia Financial, which was acquired by Daintree BidCo.
