Is there no stopping this groundbreaking ASX healthcare share?

This ASX healthcare share has caught fire recently. Imricor Medical Systems Inc (ASX: IMR) has surged 52% over the past 12 months.

On Wednesday the ASX small-cap healthcare stock gained another 7.8% at $2.20, bringing this year’s gain to 44%.

Investors are clearly backing what the ASX healthcare share is building in a US$10 billion market. And is there more to come?

Global first in cardiac care

Imricor has been carving out a few global firsts in cardiac care recently. The US-based medical technology business focuses on MRI-guided cardiac ablation and claims to be the first to deliver commercially viable MRI-compatible consumables for these procedures.

Last month the ASX healthcare share announced that its NorthStar Mapping System is the first MRI-native 3D mapping and guidance system cleared by the FDA. It also marks Imricor’s first capital equipment and first software-driven approval in the US.

This wasn’t an overnight win. Imricor says NorthStar’s FDA clearance caps years of R&D, third-party collaboration, and regulatory heavy lifting. The system is built to anchor every interventional cardiac MRI (iCMR) lab as its central hub.

Multiple clearances expected

Crucially, FDA approval opens the door to commercial sales of NorthStar in the United States — the world’s largest electrophysiology market. And the pipeline isn’t slowing.

Management expects multiple regulatory clearances this year as it rolls out its full MRI-guided electrophysiology platform. Investors in the ASX healthcare share are eagerly awaiting what management will reveal on 25 February when it delivers its second-half 2025 results.

Management said NorthStar’s clearance was the company’s second FDA win. It followed 510(k) approval for the VisionMR Diagnostic Catheter earlier in January. The approval further cements Imricor’s push to lead the MRI-guided interventional market.

Technology that matters

The innovations of the ASX healthcare share matter. Traditional ablation relies on X-ray guidance. Imricor’s iCMR platform lets doctors see the heart in real time using MRI.

That means better soft tissue visibility, no radiation exposure, and potentially better outcomes. If adoption builds, MRI-guided ablation could shift from niche to standard practice.

What next for the ASX healthcare share?

In March last year, the medical company raised $70 million to fund global expansion, commercial growth and R&D. Imricor isn’t thinking small. It is rolling out across four key regions: the US, Australia and New Zealand, the Middle East, and Europe, where it holds CE Mark approval.

It’s expanding into Germany, the Netherlands, France and Italy, running more US trials to secure FDA clearance, and has already signed exclusive distribution deals in the Middle East, including first sales in Qatar.

Analyst coverage is limited. TradingView data show that 3 brokers rate the $660 million ASX healthcare a strong buy. They have set an average 12-month price target of $2.49, which points to a 13% upside.

The most bullish analyst sees a possible gain of 26% for the next 12 months.  

The post Is there no stopping this groundbreaking ASX healthcare share? appeared first on The Motley Fool Australia.

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Motley Fool contributor Marc Van Dinther has positions in Imricor Medical Systems. 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.