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Pro Medicus (ASX:PME) share price falls after FDA news

The Pro Medicus Ltd (ASX: PME) share price is down despite announcing some positive news from the FDA.

Pro Medicus describes itself as a leading medical imaging IT provider. It offers a full range of radiology IT software and services to hospitals, imaging centres and health care groups worldwide.

Pro Medicus’ FDA news

The company announced that it has received FDA clearance for its breast density AI algorithm. This is in addition to previously receiving CE clearance from Europe and TGA clearance in Australia, paving the way for the company to market the algorithm across all three jurisdictions.

Pro Medicus explained that the breast density algorithm is intended for use with compatible full field digital and digital breast tomosynthesis systems. It assesses breast density from a mammography study and provides an ACR BI-RADS Atlas 5th edition breast density category to aid radiologists in the assessment of breast tissue composition.

The company said that this paves the way for commercialisation in North America, Europe and Australia.

Pro Medicus CEO Dr Sam Hupert said: “We developed this algorithm using our own AI accelerator platform which enabled us to significantly speed up every stage of the process from concept to FDA approval. 

This not only provides us with a fast-track mechanism to develop our own algorithm in the future, it paves the way for further collaborations with the growing number of our research orientated clients.”

What to make of this announcement

There weren’t any financial numbers given in the announcement, so it’s hard to judge what kind of financial impact this will have.

The world is moving increasingly towards technology and artificial intelligence, so it’s good to see that Pro Medicus is getting ahead. Hopefully it can claim clear market leadership with this.

I think Pro Medicus is one of the highest quality businesses on the ASX share. But the strength of its share price performance over the last 10 months – roughly doubling – means I don’t think it’s the best idea to buy today despite recent contract wins. Instead, there are other ASX growth shares that I like the look of such as Volpara Health Technologies Ltd (ASX: VHT) and Pushpay Holdings Ltd (ASX: PPH).

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