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Intended Use

aPROMISE is intended to be used by healthcare professionals and researchers for acceptance, transfer, storage, image display, manipulation, quantification and reporting of digital medical images acquired using nuclear medicine imaging, specifically PSMA PET/CT. It provides PACS tools and a clinical application for oncology including marking of regions of interest and quantitative analysis.

Technology

aPROMISE is a cloud-based software platform accessible via web interface, compliant with DICOM 3 standard for whole body PET and CT images. It provides multiple scan upload, displays studies in PET, CT, PET/CT fusion and MIP views, supports AI-enabled automated segmentation of skeleton and soft tissue organs, automated hotspot detection and quantitative analysis of regions of interest. Users verify image and study quality before report generation. Reports are electronically signed and can be exported as images or DICOM files.

Performance

Performance validation included a digital phantom validation study demonstrating accuracy and linearity of SUV and volume quantification, a comparison to predicate device showing equivalent marking and quantitative performance, and a clinical study demonstrating automated quantification reproducibility and high sensitivity for suspicious lesion detection. Software was verified and validated according to FDA guidance, with moderate level of concern. No sterilization or biocompatibility concerns as it is software-only.

View FDA documentation

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    5/28/2021

    2 months
  • 2

    FDA Approval

    7/27/2021

Other devices from EXINI Diagnostics AB

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