Imricor Medical Systems Inc (ASX: IMR) shares are racing higher on Thursday after the company released an update that has excited investors.
At the time of writing, the ASX healthcare stock is up 15.24% to $2.08.
That adds to a much better run in 2026, with the share price now up around 36% since January.
The latest gain is tied to Imricor's MRI-guided medical technology, which has been a key part of its US plans.
It is still early days, but today's announcement gives shareholders a better idea of how the US opportunity may build from here.
Let's take a look.
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FDA clearance gives Imricor a lift
According to the release, Imricor has received FDA 510(k) clearance to expand the labelling for its NorthStar system to include pediatric use.
This means the US Food and Drug Administration has reviewed the device and is comfortable that it is similar enough to another product already sold in the country.
The company also received the same clearance for its Vision-MR Diagnostic Catheter.
Essentially, both products can now be marketed for use in children, as well as adults, in the United States.
This follows the FDA clearance Imricor received in January for adult patients, with the company submitting the pediatric label expansion in April.
A new US pathway opens up
Imricor's technology lets doctors carry out some procedures inside an MRI scanner.
That means they do not need to rely as much on X-ray equipment, which can expose patients and hospital staff to radiation.
The new clearance means Imricor's technology can now be used in children for MRI-guided procedures, including cardiac catheterisations.
That could be useful for young patients, especially if they need more than one procedure over time.
Imricor said more than 250,000 diagnostic right and left heart catheterisations are performed each year in the US across adult and children's hospitals.
The company sees diagnostic procedures as another possible market for NorthStar, which helps guide doctors during MRI-based procedures.
Why investors are looking further ahead
Imricor believes the pediatric market could become an early entry point for NorthStar and its Vision-MR Diagnostic Catheter.
That's because children's hospitals may have a stronger reason to look at technology that reduces radiation exposure during procedures.
If hospitals start adopting the system, it could help Imricor build a stronger base in the United States before pushing deeper into the adult market.
Chair and CEO Steve Wedan said the company wants to help doctors and patients move away from radiation-heavy procedures where possible.
