Integrated Devices: A New Regulatory Pathway to Promote Revolutionary Innovation.

Policy Points Current medical device regulatory frameworks date back half a century and are ill suited for the next generation of medical devices that involve a significant software component. Existing Food and Drug Administration efforts are insufficient because of a lack of statutory authority, whereas international examples offer lessons for improving and harmonizing domestic medical device regulatory policy. A voluntary alternative pathway built upon two-stage review with individual component review followed by holistic review for integrated devices would provide regulators with new tools to address a changing medical device marketplace.

The Variability of Semen Parameters With Sexual Abstinence Using Mail-in Sperm Testing Is Similar to That Seen With Traditional In-Office Semen Analysis.

The impact of ejaculatory abstinence on semen parameters using in-office semen analyses has been well-established; however, their variability has not been evaluated in men using mail-in semen analysis kits. Our study aims to describe how the sperm parameters using mail-in semen analysis tests change with abstinence and validate their equivalence to those seen with in-office semen analysis tests. We retrospectively reviewed the semen analysis results of men using mail-in semen analysis tests provided by Give Legacy, Inc (Legacy) facilities from 2019 to 2021. We collected their demographic information, abstinence duration, and semen parameters (conventional and kinematic) from their records. Semen samples were categorized as normozoospermic and oligozoospermic based on concentration. The shape of the relationship between abstinence duration and semen parameters was assessed via generalized additive models. We have collected 3,469 unique samples provided by 2,609 (75%) normozoospermic men and 860 (25%) oligozoospermic from all over the United States. In normozoospermic men, longer periods of sexual abstinence were linked to higher levels of sperm concentration, total sperm count, and total motile sperm. However, there was a decline in both total and progressive motility. Conversely, in oligozoospermic men, extended periods of abstinence led to a rapid decline in total motile sperm, as well as total and progressive motility. There was no significant correlation observed between sexual abstinence and variations in sperm morphology. Our study shows that variability of sperm parameters with abstinence, as measured through mail-in semen analysis tests, is comparable to the patterns observed with conventional in-office sperm testing.

Recall patterns and risk of primary liver cancer for subcentimeter ultrasound liver observations: a multicenter study.

BACKGROUND: Patients with cirrhosis and subcentimeter lesions on liver ultrasound are recommended to undergo short-interval follow-up ultrasound because of the presumed low risk of primary liver cancer (PLC). AIMS: The aim of this study is to characterize recall patterns and risk of PLC in patients with subcentimeter liver lesions on ultrasound. METHODS: We conducted a multicenter retrospective cohort study among patients with cirrhosis or chronic hepatitis B infection who had subcentimeter ultrasound lesions between January 2017 and December 2019. We excluded patients with a history of PLC or concomitant lesions ≥1 cm in diameter. We used Kaplan Meier and multivariable Cox regression analyses to characterize time-to-PLC and factors associated with PLC, respectively. RESULTS: Of 746 eligible patients, most (66.0%) had a single observation, and the median diameter was 0.7 cm (interquartile range: 0.5-0.8 cm). Recall strategies varied, with only 27.8% of patients undergoing guideline-concordant ultrasound within 3-6 months. Over a median follow-up of 26 months, 42 patients developed PLC (39 HCC and 3 cholangiocarcinoma), yielding an incidence of 25.7 cases (95% CI, 6.2-47.0) per 1000 person-years, with 3.9% and 6.7% developing PLC at 2 and 3 years, respectively. Factors associated with time-to-PLC were baseline alpha-fetoprotein >10 ng/mL (HR: 4.01, 95% CI, 1.85-8.71), platelet count ≤150 (HR: 4.90, 95% CI, 1.95-12.28), and Child-Pugh B cirrhosis (vs. Child-Pugh A: HR: 2.54, 95% CI, 1.27-5.08). CONCLUSIONS: Recall patterns for patients with subcentimeter liver lesions on ultrasound varied widely. The low risk of PLC in these patients supports short-interval ultrasound in 3-6 months, although diagnostic CT/MRI may be warranted for high-risk subgroups such as those with elevated alpha-fetoprotein levels.

Geographic Differences in Semen Quality among a Cohort of American Men Using Mail-in Sperm Testing Kits.

PURPOSE: To evaluate the relationship between regional geography and sperm parameters in a cohort of American men using at-home mail-in semen collection kits with no previous self-reported history of male factor infertility. MATERIALS AND METHODS: In this study, 5,822 men from six different regions of the United States (Northeast, Southeast, Midwest, West, Pacific, and Southwest) who self-requested semen analysis between 2019 and 2021 were enrolled. RESULTS: Across the entire cohort, the mean sperm concentration was 43.79±55.43 ×106 sperm/mL; total sperm count 138.93±149.96 ×106 sperm/mL; total motile sperm 54.73±81.90 ×106/ejaculate; total motility 30.18%±22.87%; progressive motility 21.61%±17.32%; sperm with normal morphology 8.79%±8.87%. Patients from the West region displayed lower median sperm concentration, total motile sperm, and total motility than men from the other four regional areas. A lower median total sperm count, and lower median progressive motility were also detected among patients in the Southwest region. Conversely, higher results were detected in patients from the Midwest (higher median total motile sperm, total and motility) and from the Northeast (higher median sperm concentration and total sperm count) regions. Men from the Southeast (OR, 1.3168; 95% CI, 1.1142-1.5563) and Southwest (OR, 1.3145; 95% CI, 1.0735-1.6096) regions were more likely to have oligozoospermia than those living elsewhere. CONCLUSIONS: This study provides the most comprehensive and up-to-date report on semen parameter variability among a cohort of men living in six different regions of the continental USA. This study will pave the way into a deeper discussion of the interplay between geography, social determinants of fertility care and semen quality.

Semen parameter variability among users of at-home sperm testing kits.

BACKGROUND: Despite the generally accepted World Health Organization guidelines on semen analysis, an individual's results can display significant variation when performed across time or in different laboratories. Semen parameters are in fact highly variable measures that can differ significantly between various analyses. Numerous researchers have discovered a wide range of semen parameters within each individual male, but only a few studies included the analysis of semen parameters variability in patients with infertility. The aim of this study was to evaluate the inter- and intra-individual variability of semen parameters in men of reproductive age with normozoospermia and those with oligozoospermia. METHODS: Five hundred and thirteen who provided ≥ 2 semen samples (798 samples in total) using an at-home mail-in kit over a period of about 2 years were enrolled in the study. Semen samples collection using Give Legacy at-home mail-in semen collection kit; semen analysis at a CLIA-certified laboratory. RESULTS: The degree of intra-subject variation across all semen parameters was lower in men with normozoospermia compared to men with oligozoospermia. Men with normozoospermia furthermore demonstrated a level of intra-subject variation that was lower than inter-subject variation across all measured parameters. No association was observed between intra-subject coefficients of variation in any of the semen parameters, including sperm concentration, sperm count, motile sperm count, total motility, progressive motility, the percentage of sperm with normal morphology, and the age, duration of abstinence, and BMI of the men. CONCLUSION: The results of this observational study confirm the significant variability in semen parameters in men with normozoospermia and oligozoospermia, as measured from at-home semen collection kit samples. This further underscore the importance of securing multiple samples for analysis to provide a robust assessment of male fertility.

It Takes a Village: A Multimodal Approach to Addressing Radiologist Burnout.

Burnout is a significant issue confronting the medical profession, to which radiology is no exception. Addressing burnout demands a full-spectrum response, in keeping with its complexity, prevalence, and significance. This manuscript brings together key techniques at the individual, peer, and institutional levels to offer a multifaceted approach to ameliorating radiologist burnout. Such an approach would begin by equipping physicians with the skillset necessary to identify signs of burnout in themselves and others. Institutions can work to validate the radiologists they employ and work toward mitigating the impact of occupational stressors. Lastly, engaging in conversations about burnout throughout the course of one's medical career can affect a sea change in the way burnout is envisioned, and treated.

Clinical applications of AI in MSK imaging: a liability perspective.

Artificial intelligence (AI) applications have been gaining traction across the radiology space, promising to redefine its workflow and delivery. However, they enter into an uncertain legal environment. This piece examines the nature, exposure, and theories of liability relevant to musculoskeletal radiologist practice. More specifically, it explores the negligence, vicarious liability, and product liability frameworks by way of illustrative vignettes.

Safeguarding Data Security in the Era of Imaging mHealth.

Mobile health (mHealth) technologies stand poised to find broad application in the radiology space. They hold considerable promise for millions of patients in the United States, enabling at-home imaging and augmenting clinical decision-making. However, they often lie outside the ambit of FDA regulation and process vast quantities of data largely unprotected by HIPAA. This article explores features of federal mHealth policy relevant to imaging practice and advocates for greater regulatory clarity to assist radiologists, developers, and ultimately, patients.

Regulatory Issues and Challenges to Artificial Intelligence Adoption.

Artificial intelligence technology promises to redefine the practice of radiology. However, it exists in a nascent phase and remains largely untested in the clinical space. This nature is both a cause and consequence of the uncertain legal-regulatory environment it enters. This discussion aims to shed light on these challenges, tracing the various pathways toward approval by the US Food and Drug Administration, the future of government oversight, privacy issues, ethical dilemmas, and practical considerations related to implementation in radiologist practice.

Time to Revisit a Voluntary FDA Comparative Effectiveness Pathway.

Given the renewed policy focus on drug pricing and pharmaceutical innovation, this article examines the historical backdrop of efforts to integrate comparative effectiveness research into the FDA drug review process. Noting previous policy efforts over a decade ago, we characterize industry challenges and suggest a path forward.