aBSI is a software-only medical device designed to quantitatively assess and analyze skeletal disease burden on bone scans from nuclear medicine imaging. It helps healthcare professionals by automatically detecting and quantifying lesions to support clinical decision-making, particularly in oncology, by measuring disease extent in the skeleton.
Intended Use
aBSI is intended to be used by trained healthcare professionals and researchers for acceptance, transfer, storage, image display, manipulation, quantification and reporting of digital medical images acquired using nuclear medicine imaging. It provides PACS tools and clinical applications for oncology including lesion marking and quantitative analysis.
Technology
aBSI is a software-only medical device that quantitatively assesses a patient’s skeletal disease on bone scans by detecting high intensity regions within a refined skeletal atlas covering from skull to entire femur and humerus. It uses DICOM SPECT images and provides cloud-based access with features such as automatic image adjustment, hotspot detection, and exportable summary data.
Performance
Performance testing included software verification and validation, analytical validation studies of linearity, accuracy, precision, reproducibility, and phantom comparisons against predicate device. Two clinical studies demonstrated predictive value of automated Bone Scan Index (aBSI) in metastatic castration-resistant prostate cancer patients, associating aBSI with overall survival and radiographic progression.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
5/10/2019
2 months - 2
FDA Approval
8/5/2019
Other devices from EXINI Diagnostics AB
- aPROMISE X2022 • 510K
- aPROMISE2021 • 510K
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