Research & Development
Subtle Medical passes the US FDA 510(k) clearance and CE Mark approval for SubtlePET for medical imaging
6 December 2018 -

Medical device company Subtle Medical disclosed on Wednesday the receipt of the US Food and Drug Administration's (FDA) 510(k) clearance to market SubtlePET under its growing portfolio of new AI technologies.

Additionally, the company has received the approval to affix the CE Mark on SubtlePET to begin marketing in the European Economic Area without restrictions.

The SubtlePET's artificial intelligence (AI)-powered technology allows hospitals and imaging centers to enhance images from faster scans leading to an improved patient experience during imaging procedures, while boosting exam throughput and provider profitability. SubtlePET delivers a significant improvement in the image quality of noisy images resulting from shorter scans, which is particularly beneficial for children and those undergoing repeat PET exams.

Currently, SubtlePET is in pilot clinical use in multiple university hospitals and imaging centres in the US and abroad, added the company.

According to the company, the AI solution enables completion of more exams in a day compared to conventional PET imaging without the need for capital expenditures. It reduces patient time in the scanner and helps hospitals and imaging centres enhance their bottom line in today's competitive healthcare environment.

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