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.
UroGen's UGN-103 IND accepted by FDA for bladder cancer treatment
MaaT Pharma reveals positive 18-month data for MaaT013 in GI-aGvHD
Innate Pharma advances Sanofi-developed NK cell engager to Phase 2 for blood cancer patients
Soligenix receives orphan drug designation from FDA for active ingredient in SuVax
Candel Therapeutics granted FDA Orphan Drug Designation for CAN-2409 in pancreatic cancer treatment
Lipogems completes patient enrolment in ARISE I US FDA IDE study
Amylyx Pharmaceuticals' AMX0035 shows promising impact on Wolfram syndrome symptoms
Roche attains CE Mark for first companion diagnostic for HER2-low metastatic breast cancer
Cadrenal Therapeutics' tecarfarin receives US FDA Orphan Drug Designation
BioCity Biopharma's BC2027 Phase one study IND application receives US FDA approval
Seres Therapeutics completes patient enrollment for SER-155 Phase 1B trial