One of the best performers on the All Ordinaries index today has been Imricor Medical Systems Inc (ASX: IMR) shares.
At the time of writing, this ASX stock is up 18% to a 52-week high of $2.25.
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Why is this ASX stock jumping today?
Investors have been bidding this medical device company's shares higher today after it made a big announcement.
According to the release, the United States Food and Drug Administration (FDA) has granted 510(k) clearance for the company's NorthStar Mapping System under the premarket notification process.
NorthStar is the first and only MRI-native 3D mapping and guidance system to receive FDA clearance. It is Imricor's first capital equipment and first software-centric product approval in the United States.
Management notes that this marks the ASX stock's second FDA clearance, after receiving 510(k) clearance for the VisionMR Diagnostic Catheter earlier this month. It believes the approval significantly strengthens Imricor's position as the market leader in MRI-guided interventional procedures.
This was no overnight success. The company highlights that NorthStar's clearance by the U.S. FDA marks the culmination of years of research, development, 3rd party partnerships, and regulatory work. The system is designed and intended to be the central hub of every interventional cardiac MRI lab (iCMR).
And there may be more to come. Management is expecting multiple regulatory clearances and approvals this calendar year, as its full MRI-guided electrophysiology platform is progressively introduced to the market.
This FDA clearance enables the ASX stock to commercially market NorthStar in the United States, which is the world's largest electrophysiology market.
Commenting on the news, Imricor's chair and CEO, Steve Wedan, said:
At Imricor, we have been building a comprehensive suite of uniquely MRI-compatible devices for two decades. These devices, which include both consumable products and capital equipment, enable doctors to harness the superior soft tissue imaging of MRI to precisely guide minimally invasive procedures in a 100% radiation-free setting. Our goal is to enable better, faster, safer and less expensive treatments for patients worldwide; and as the world's largest market, the United States is critical to our goal.
When it comes to iCMR procedures, NorthStar is the central hub that brings everything together. It's designed to not only facilitate diagnostic cardiac electrophysiology and ablations procedures, but also to provide MRI guidance capabilities for other procedures. And since NorthStar is primarily a software product, it ushers in Imricor's software era in which AI will play a big role in the future. NorthStar's platform provides a path for capability expansion that is virtually unlimited, and we will continue to invest in and expand its capabilities for years to come.
