Trends in software as a medical device (Preprint)

UNSTRUCTURED Software-as-a-medical-device (SaMD) has gained popularity as a type of medical device. However, to date, empirical analysis of SaMD trends have been lacking. Using databases managed by the US medical device regulator (the Food and Drug Administration), we map the path SaMD takes towards classification and recorded adverse events. The findings show that while SaMD has been identified in literature as an area of development, the data analysis suggests that this growth has been modest. These devices are overwhelming classified as moderate to high risk and they take a very particular path to that classification. The digital revolution in health care is less pronounced when evidence is considered of SaMD. In general, the trend for software registration mimics that of medical devices.

Is Visual Registration Equivalent to Semiautomated Registration in Prostate Biopsy?

In magnetic resonance iimaging- (MRI-) ultrasound (US) guided biopsy, suspicious lesions are identified on MRI, registered on US, and targeted during biopsy. The registration can be performed either by a human operator (visual registration) or by fusion software. Previous studies showed that software registration is fairly accurate in locating suspicious lesions and helps to improve the cancer detection rate. Here, the performance of visual registration was examined for ability to locate suspicious lesions defined on MRI. This study consists of 45 patients. Two operators with differing levels of experience (<1 and 18 years) performed visual registration. The overall spatial difference by the two operators in 72 measurements was 10.6 ± 6.0 mm. Each operator showed a spatial difference of 9.4 ± 5.1 mm (experienced; 39 lesions) and 12.1 ± 6.6 mm (inexperienced; 33 lesions), respectively. In a head-to-head comparison of the same 16 lesions from 12 patients, the spatial differences were 9.7 mm ± 4.9 mm (experienced) and 13.4 mm ± 7.4 mm (inexperienced). There were significant differences between the two operators (unpaired,Pvalue = 0.042; paired,Pvalue = 0.044). The substantial differences by the two operators suggest that visual registration could improperly and inaccurately target many tumors, thereby potentially leading to missed diagnosis or false characterization on pathology.

Organizational Software Use Policies

This chapter discusses organizational software use policies. Specifically it gives the meaning of software use policy, software use policy components bothering on; general statement of policy, user education, budgeting and acquisition of software, registration, installation, storage and documentation of software, record keeping, software use, internet and shareware use, software audit and use survey, employee/user duty to report underlicensing, disciplinary measures on defaulters, corporate handling of employee questions regarding an organization’s software, need for software use policy in an organization, organizational software use policy formulation process, qualities of a software use policy, policy education and enforcement, problems of software use policy as well as future trends in organizational software use policy.

Does PET/CT render software registration obsolete?

Summary:It was the success of software-based image registration that eventually led to the introduction of hardware-based concepts for image fusion, such as combined PET/CT tomographs. A prototype PET/CT was first presented in 1998, with various commercial designs to follow since 2000. PET/ CT is used primarily as a diagnostic modality in the field of extra-cerebral oncology imaging. The major advantage of combined imaging over retrospective software registration is the nearly identical position of the patient during both complementary examination, and therefore tomograms of identical parts of the body can be provided in spatially-corresponding slices. Despite the availability of hardware combinations of complementary imaging modalities software-based image registration, however, still inherits a major role in subsequent data processing, in particular when individual imaging modalities other than combined PET/CT are being used during patient workup. Furthermore, software is likely to become an important tool for the correction of residual motion-induced mis-registration within combined PET/CT data sets, and for follow-up studies involving, for example, CT, PET, and PET/CT. Therefore, flexible algorithms that utilize nonlinear interpolation schemes implemented on fast computer systems are needed, and will continue to contribute to successful image registration and fusion in clinical practice.