AI in Healthcare - Will It Get Bigger on the ASX?
The United States regulator has authorised more artificial intelligence (AI) medical devices in each year from 2017 to 2025. This piece looks at four ASX companies that sell AI software to hospitals and clinics. It asks whether the group is likely to get bigger. One of the four is Echo IQ (ASX: EIQ), which Samso has followed since 2025. On 8 September 2026 the company said the regulator had not cleared its second product. The share price halved after the news. Our earlier pieces are listed under Previous Samso Coverage.
All prices in this piece are as at the close of ASX trading on 9 October 2026.
What AI in Healthcare Means for an ASX Investor
In this piece, AI in healthcare means software that reads a medical scan or test and gives the doctor a measurement or a flag. The doctor still makes the decision.
The main market is the United States. A product of this kind needs authorisation from the Food and Drug Administration (FDA) before it can be sold there. Most software gets it through a route called 510(k), and the result is called a clearance. In a 510(k), the company shows its product is substantially equivalent to one already on the market.
The FDA keeps a public list of AI-enabled devices it has authorised for sale. Most are 510(k) clearances. The list held 1,614 devices when we read it on 11 October 2026. [R1] Radiology, the reading of scans, accounts for 1,230 of them, or 76 per cent. The FDA authorised 335 in 2025 against 114 in 2020 (FIGURE 01). Samso counted the yearly figures from the FDA file.
Clearance lets a company sell its product, and it still has to find buyers. More than 1,600 authorised devices may also mean more competition.
The Four ASX Healthcare AI Companies
We have chosen four companies. Each has at least one product cleared by the FDA. Products from Pro Medicus, Artrya and Echo IQ are on the FDA list. The 4DMedical clearance is as the company announced it. [R16] The market values in the table are rounded, because we took them from the ASX data feed and did not check the share counts. TABLE 01 sets the four companies side by side.
Pro Medicus is the large one. Its Visage 7 software lets radiologists view and report on scans, and hospitals pay by the number of scans under long contracts. It reported revenue of A$261.7 million for the year to 30 June 2026. [R2] It also has an AI product of its own, Visage Breast Density, which the FDA cleared in January 2021. [R1] The A$261.7 million covers the whole business, and AI is one part of it.
4DMedical turns an ordinary chest computed tomography (CT) scan into a map of how air and blood move through the lungs. Artrya reads a CT scan of the heart arteries and reports narrowing and plaque, the fatty build-up in the artery wall. Two Artrya modules were cleared in 2025 and a third is not yet cleared. [R8] [R9] Echo IQ reads the measurements from a heart ultrasound to flag severe aortic stenosis, a narrowing of the valve through which blood leaves the heart.
The three smaller companies are early in their sales. 4DMedical reported revenue of A$7.1 million for the year. [R6] Artrya reported A$28,000. [R8] Echo IQ reported A$91,646. [R10] Their market values are about A$2.4 billion, about A$500 million and about A$400 million. [R15] Those market values rest on sales that are still to come.
Pro Medicus as a Lender to Smaller AI Companies
Pro Medicus has lent to one of the other three and has agreed to fund a second. In July 2025 it lent 4DMedical A$10 million for two years at 12.5 per cent interest, with an option to distribute 4DMedical products. [R3]
In June 2026 it agreed to put up to A$20 million into Echo IQ through convertible notes. A convertible note is a loan that the lender can swap for shares. The notes carry interest of 12.5 per cent. Pro Medicus can choose whether to provide the second A$10 million. That second amount is tied to FDA clearance of Echo IQ's second product. Pro Medicus would also resell the Echo IQ products in the United States. [R4] The note agreements were signed on 17 August 2026. [R10]
This is one way the group can grow. Pro Medicus already has its software inside large American hospitals. A small company that sells through Pro Medicus gets access to those hospitals. We have not confirmed that the first A$10 million has been paid to Echo IQ. The second A$10 million is tied to a clearance the FDA has not given so far.
Who Pays for the AI Scan
A hospital is more likely to use the software widely if someone pays for each use. In the United States that depends on two things. One is a billing code, known as a CPT code. The other is the rate an insurer pays against it. Medicare, the government insurer mainly for people aged 65 and over, publishes its rates. Private insurers set their own.
Artrya says its plaque analysis is billed under an existing code at US$950 per scan assessed. [R8] 4DMedical says the rate set by the Medicare agency for its lung scan is US$650.50. [R7] A rate like this goes to the hospital or clinic that bills the code. The software company's share is a separate matter. Echo IQ does not have a code of its own. Its customers seek payment under a miscellaneous code, and its application for a specific one was not approved in September 2025. [R10]
Put together, Artrya and 4DMedical each report a stated rate, and Echo IQ does not have a specific code. We have not checked these rates against the Medicare schedules. A code also does not mean a hospital will order the scan.
The Echo IQ FDA Decision in September 2026
Echo IQ's first product, EchoSolv AS, was cleared in October 2024. Its second, EchoSolv HF, is for heart failure. On 8 September 2026 the company said the FDA had issued a Not Substantially Equivalent determination on its application. [R12] In plain terms, the FDA did not accept that the product matched one already on the market, so it is not cleared.
Echo IQ says it disagrees with the FDA on some points and believes there is still a path to clearance. It also says the decision does not affect EchoSolv AS. [R12] On 17 September it said the FDA's concerns were limited to the statistical analysis behind the clinical validation. It named three routes, which are an appeal, a review by the FDA Ombudsman and a new application. [R17] On 12 October it said it had filed an appeal and that the FDA had accepted it. It expects a meeting with the FDA within 30 days. [R19]
The shares last traded at A$1.28 on 4 September. They were in a trading halt on 7 and 8 September and closed at 64 cents on 9 September. [R18] We can probably safely assume the fall was due to the FDA decision. On 1 July 2026 the company said institutions had committed about A$110 million at A$1.45 a share. [R11] The shares closed at 53 cents on 9 October 2026, below that price.
The company said on 8 September that it had cash of more than A$105 million as at July 2026. [R12] For a shareholder that means Echo IQ has that cash and one product it can sell in the United States. The second is not cleared and is under appeal.
Share Prices of the Four Companies Over the Past Year
We ran through the charts of all four (FIGURE 02, which shows two years). Over the year to 9 October 2026, Pro Medicus is down 44 per cent, from A$298.02 to A$165.73. 4DMedical is up 74 per cent. Artrya is up 14 per cent. Echo IQ is up 194 per cent after the September fall. The S&P/ASX 200 Health Care index, which tracks the larger listed health companies, is down 15 per cent over the same year. [R15] Pro Medicus has large sales and its shares fell over the year. The other three have small sales and their shares rose.
The other three are much smaller than Pro Medicus. Their prices can move a long way on one announcement, as Echo IQ shows. Their charts should not be read as literally as the chart of a large company.
Companies Leaving and Joining the ASX
Volpara Health Technologies, a breast imaging AI company, was bought by Lunit at A$1.15 a share and left the ASX in May 2024. [R14]
Harrison.ai is a private Australian healthcare AI company. The ABC reported on 8 September 2026 that it had cut Australian staff and was starting a radiology service in the United States. [R13] The ABC also reported a June job advertisement that referred to getting ready for an ASX listing. The company has not announced one. We did not find a healthcare AI company that listed on the ASX in 2026. Identifai Genetics, a prenatal genetic testing company that Samso covered in September, is due to list in October 2026. We have not counted it as a healthcare AI company. The listed group can shrink through a takeover.
Samso Concluding Comments
Will AI in healthcare get bigger on the ASX? We think it probably will, if bigger means more products and more money raised. It has not meant more listed companies so far. The FDA is authorising more AI devices each year. Each of the three smaller companies holds far more cash than it earned in sales last year. 4DMedical had A$278 million at 30 June 2026. [R5] Artrya had A$74 million in cash and term deposits. [R9] Echo IQ reported more than A$105 million as at July 2026. [R12]
We cannot yet say whether sales will get bigger. Only Pro Medicus earns large sales today. For the other three, what comes next is hospitals using the product and insurers paying for it.
SAMSO TAKE A product of this kind can depend on one decision by a regulator. Echo IQ's shares fell from A$1.28 to 64 cents after one. We think investors can check three things. Is the product cleared? Is there a billing code for it? Are customer receipts in the quarterly cash report going up? |
THE OTHER WAY TO READ THIS The share prices may already allow for the growth. Market values are many times sales at all four companies. [R15] Pro Medicus, the one with large sales, is down 44 per cent over the year. A rising count of FDA clearances may also mean more competition for each company. Only one of the four has large sales. Echo IQ's second product is not cleared. The listed group lost Volpara to a takeover in 2024, and we did not find a new healthcare AI listing in 2026. |
Previous Samso Coverage of ASX Healthcare AI
Samso has written on Echo IQ since 2025 and on other healthcare AI subjects in 2026. The pieces are listed newest first.
29 APRIL 2026 Echo IQ – EchoSolv AS Enters Mount Sinai Health System
23 APRIL 2026 AI and Dementia: How Artificial Intelligence Is Changing Diagnosis, Care and Early Detection
15 APRIL 2026 Echo IQ – AI Diagnostics, Mayo Clinic & Hypergrowth
25 MARCH 2026 Echo IQ – Mayo Clinic Agreement Expands Commercial Pathway for EchoSolv HF After FDA Clearance
13 JANUARY 2026 ASX Healthcare Companies Snapshot – 4DMedical Limited | Actinogen Medical Limited | Neuren Pharmaceuticals Limited | Oneview Healthcare PLC
25 NOVEMBER 2025 Echo IQ Limited - EchoSolv HF Validated at Mayo Clinic Platform – Lining Up for FDA 510(k) Submission
VOCABULARY 510(k). The usual FDA route for medical software. The company shows its product is substantially equivalent to one already legally on the market. The result is called a clearance. Not Substantially Equivalent. An FDA finding that a 510(k) product has not been shown to match an existing one. The product is not cleared. CPT code. A billing code used in the United States. Hospitals and doctors use it to bill an insurer. Medicare. The United States government health insurer mainly for people aged 65 and over. Convertible note. A loan that the lender can swap for shares in the borrower. Placement. A sale of new shares to selected large investors. Appendix 4C. The quarterly cash report that some ASX companies must lodge. It shows cash received from customers and cash spent. Market value. The share price multiplied by the number of shares on issue. |
References and Sources
Each source has a marker such as [R1]. The same marker appears in the text where that source is used. Company figures are quoted from the documents named. The two figures and the table are original Samso illustrations of sourced data.
[R1] FDA, Artificial Intelligence-Enabled Medical Devices list, page updated 4 September 2026. Read 11 October 2026. fda.gov.
[R2] Pro Medicus, full year results announcement, 18 August 2026. announcements.asx.com.au.
[R3] 4DMedical, "4DMedical secures $10m strategic investment from Pro Medicus", 31 July 2025. announcements.asx.com.au.
[R4] Echo IQ, "Binding Heads of Agreement secured with leading health imaging company, Pro Medicus Limited (ASX: PME)", 25 June 2026. announcements.asx.com.au.
[R5] 4DMedical, quarterly activities report and Appendix 4C for the June 2026 quarter, 31 July 2026. announcements.asx.com.au.
[R6] 4DMedical, Appendix 4E for the year to 30 June 2026, 28 August 2026. bulletin.webull.com.
[R7] 4DMedical, investor presentation, 19 January 2026. announcements.asx.com.au.
[R8] Artrya, Appendix 4E and Annual Report for the year to 30 June 2026, 19 August 2026. bulletin.webull.com.
[R9] Artrya, quarterly activities report and Appendix 4C for the June 2026 quarter, 29 July 2026. investorpa.com.
[R10] Echo IQ, Annual Report for the year to 30 June 2026, 28 August 2026. bulletin.webull.com.
[R11] Echo IQ, "EchoIQ receives firm commitments for a ~A$110m institutional placement to fund US commercial expansion and accelerate EchoSolv AI product pipeline", 1 July 2026. announcements.asx.com.au.
[R12] Echo IQ, "EchoSolv HF FDA application update", 8 September 2026. announcements.asx.com.au.
[R13] ABC News, "Startup Harrison.ai lays off Australian staff, pivots to US after $32m government investment", 8 September 2026. abc.net.au.
[R14] Volpara Health Technologies, scheme implementation announcement, 21 May 2024. announcements.asx.com.au.
[R15] Share prices from Yahoo Finance daily closes. Market values from the ASX company data feed. Both read for the close of 9 October 2026. asx.com.au.
[R16] 4DMedical, company release on the FDA 510(k) clearance of CT:VQ, 4 September 2025. 4dmedical.com.
[R17] Echo IQ, "EchoSolv HF FDA application update", 17 September 2026. announcements.asx.com.au.
[R18] ASX, trading halt notice for EchoIQ Limited, 7 September 2026. announcements.asx.com.au.
[R19] Echo IQ, "EchoSolv HF FDA 510(k) update", 12 October 2026. cdn-api.markitdigital.com.
Cover photo: A computed tomography (CT) scanner at Craig Joint Theater Hospital, Bagram Air Field, in 2015. US Air Force photo by Senior Airman Cierra Presentado. Public domain, via Wikimedia Commons. The photograph is mirrored left to right and cropped. It is shown under the Samso News blue glass on the article cover.
 The Samso Way – Seek the ResearchHere at Samso, we pride ourselves on delivering content for investors that is independent and informed by over three decades of experience in the industry. Our content is well-researched and is only created if I see merit in discussing the company's story. Our mission is simple. Cut through the noise and spotlight what matters. Genuine stories, grounded insights, and real opportunity. Investors can explore our four core platforms:
There may be numerous paths to success in investing, but the common thread among successful individuals is that they remain committed to making informed decisions. Equip yourself with the right knowledge and tools, and you will be well on your way to achieving your financial goals. Most importantly, investors need to be absolutely diligent in understanding their own risk-reward tolerance and capabilities. Never bite off more than you can chew. As they say, Rome wasn't built in a day, and the Great Wall stood because it took centuries to complete. The Samso Philosophy: Stay curious. Stay sharp. And remember, digging deeper always uncovers the real value. In Life, there is no such thing as a Free Lunch. Never bite off more than you can chew is my parting comment. Happy Investing, and the only four-letter word you need to know is DYOR. To support our independent work, please head over to our Support Page and give us a helping hand in any of the ways listed. This is a new initiative for the Samso Platform, and it was always the concept of Samso when we started this journey in 2018. DisclaimerThe information or opinions provided herein do not constitute investment advice, an offer, or solicitation to subscribe for, purchase, or sell the investment product(s) mentioned herein. It does not take into consideration, nor have any regard to your specific investment objectives, financial situation, risk profile, tax position and particular, or unique needs and constraints. About SamsoSamso is a trusted platform that equips dedicated investors with up-to-date industry knowledge and insights from top CEOs and thought leaders. By staying informed on business advancements and market trends, investors can enhance their financial decisions through a combination of expert guidance and their own research. Coffee with Samso, Samso Insights, Samso News and Samso Research are four ways into the same work. Interviews, long-form research, short takes on announcements and company-specific studies. Every one of them is about how to think about investing rather than what to buy. Samso News | www.samso.com.au | An Investor Lens on ASX-Listed Companies Samso News is independent research commentary for general information only. Nothing in this article is financial product advice, and it does not take into account any reader's objectives, financial situation or needs. Figures are drawn from public sources believed reliable at the stated dates but are not guaranteed. Market-sensitive numbers change daily. Samso or associated parties may hold positions in, or have commercial arrangements with, companies mentioned. Seek professional advice before making investment decisions. © Samso 2026 · samso.com.au |
Comments