It has been another big day for 4DMedical Ltd (ASX: 4DX) shareholders.
The ASX 200 healthcare stock is pushing higher on Friday after releasing an update that has kept investors interested.
At the time of writing, the 4DMedical share price is up 8.75% to $4.97.
The stock is now up around 40% over the past month and an incredible 1,800% since this time last year.
Here's what 4DMedical announced to the market.
Image source: Getty Images
4DMedical gets TGA approval
According to the release, 4DMedical has received approval from the Therapeutic Goods Administration (TGA) for its CT:VQ product in Australia.
This means CT:VQ has now been included on the Australian Register of Therapeutic Goods, allowing it to be sold commercially across the country.
The company said CT:VQ is the world's first non-contrast, CT-based ventilation-perfusion imaging solution.
The software helps doctors see how air and blood move through the lungs using standard CT scans. Essentially, patients can be assessed without the need for some nuclear medicine imaging methods.
4DMedical said the approval could support use across metropolitan, regional, and rural Australia, including areas with CT scanners but limited access to nuclear medicine services.
The company noted that CT:VQ is already approved in several major markets, including the US, Europe, the UK, Canada, and New Zealand.
What investors will be watching now
The approval gives 4DMedical a new market to work with, but investors will want to see how quickly that turns into adoption.
Although, there's already some progress overseas.
In the United States, CT:VQ has been deployed at major clinical sites including Stanford, Cleveland Clinic, and the University of Miami.
The company has also signed an agreement with SimonMed Imaging, one of the largest outpatient radiology providers in the United States.
Back in Australia, the next step for the company is reimbursement.
Management said it is preparing an application to the Medical Services Advisory Committee to seek future Medicare Benefits Schedule reimbursement for CT.
If that's approved, it could make the product much easier to be used more widely across our healthcare system.
Can the rally keep going?
Without doubt, the approval is a positive milestone.
But after rocketing 1,800% in 12 months, this isn't a small company anymore flying under the radar.
4DMedical has a market capitalisation of around $2.8 billion, which means investors are already pricing in a much larger business.
And while that doesn't mean the rally has gone too far, it certainly does raise the bar.
For now, the company needs to keep showing that CT can move from approvals and trial sites into broader commercial use.
