It is difficult to determine a cause of bile duct stricture and dilatation. Eosinophilic cholangitis, a rare benign condition, may be one cause of bile duct stricture and dilatation. It can be evaluated using various methods of histopathology, radiographs, endoscopy, and hematologic findings. Treatment generally involves steroid therapy which can lead to improvement. This case report will discuss eosinophilic cholangitis, emphasizing that while it can easily be overlooked but should be considered in differential diagnoses.

This paper analyzes the regulatory frameworks for artificial intelligence/machine learning AI/ML-enabled medical devices in the European Union (EU), the United States (US), and the Republic of Korea, with a focus on applications in spine surgery. The aim is to provide guidance for developers and researchers navigating regulatory pathways. A review of current literature, regulatory documents, and legislative frameworks was conducted. Key differences in regulatory bodies, risk classification, submission requirements, and approval pathways for AI/ML medical devices were examined in the EU, US, and Republic of Korea. The EU AI Act (2024) establishes a risk-based framework, requiring regulatory review based on device risk, with high-risk devices subject to stricter oversight. The US applies a more flexible approach, allowing multiple submission pathways and incorporating a focus on continuous learning. The Republic of Korea emphasizes possibilities of streamlined approval and with growing use of real-world data to support validation. Developers must ensure regulatory alignment early in the development process, focusing on key aspects like dataset quality, transparency, and continuous monitoring. Across all regions, the need for technical documentation, quality management systems, and bias mitigation are essential for approval. Developers are encouraged to adopt adaptable strategies to comply with evolving regulatory standards, ensuring models remain transparent, fair, and reliable. The EU’s comprehensive AI Act enforces stricter oversight, while the US and Korea offer more flexible pathways. Developers of spine surgery AI/ML devices must tailor development strategies to align with regional regulations, emphasizing transparent development, quality assurance, and postmarket monitoring to ensure approval success.

Purpose: 11C-Methionine PET/CT is a promising method for detecting parathyroid lesions in patients with primary hyperparathyroidism (PHPT). We aimed to determine the diagnostic ability and correlation of digital 11C-Methionine PET/CT for parathyroid lesions in patients with PHPT, particularly in cases where standard imaging methods yielded inconclusive results. Methods: This retrospective analysis was conducted on patients diagnosed with PHPT who underwent digital 11C-Methionine PET/CT imaging because of ambiguous results on standard imaging work-up ( 99m Tc-MIBI parathyroid scan and/or neck ultrasonography). Quantitative 11C-Methionine PET/CT parameters, including maximum standardized uptake value (SUVmax), mean SUV (SUVmean), peak SUV (SUVpeak), parathyroid methionine volume (PMV), and whole methionine uptake(WMU: PMV multiplied by SUVmean) were calculated with various thresholds, and their correlations with biochemical andpathologic parameters were investigated. Results: This study included 22 consecutive patients (10 men and 12 women) with a median age of 64.0 years. The lesion detection rate and sensitivity of digital 11C-Methionine PET/CT were 81.8% (18/22) and 100.0% (18/18), respectively.Quantitative analysis revealed that serum PTH (r = 0.490, P = 0.039) and serum calcium (r = 0.583, P = 0.011) were signifi-cantly correlated with PMV50%. Conclusion Digital 11C-Methionine PET/CT offers good performance in the detection of parathyroid lesions in PHPT patients with inconclusive standard imaging work-up. The volume parameter of PMV50% significantly correlated biochemi-cal parameters and can serve as a complementary diagnostic tool.

It is difficult to determine a cause of bile duct stricture and dilatation. Eosinophilic cholangitis, a rare benign condition, may be one cause of bile duct stricture and dilatation. It can be evaluated using various methods of histopathology, radiographs, endoscopy, and hematologic findings. Treatment generally involves steroid therapy which can lead to improvement. This case report will discuss eosinophilic cholangitis, emphasizing that while it can easily be overlooked but should be considered in differential diagnoses.

This paper analyzes the regulatory frameworks for artificial intelligence/machine learning AI/ML-enabled medical devices in the European Union (EU), the United States (US), and the Republic of Korea, with a focus on applications in spine surgery. The aim is to provide guidance for developers and researchers navigating regulatory pathways. A review of current literature, regulatory documents, and legislative frameworks was conducted. Key differences in regulatory bodies, risk classification, submission requirements, and approval pathways for AI/ML medical devices were examined in the EU, US, and Republic of Korea. The EU AI Act (2024) establishes a risk-based framework, requiring regulatory review based on device risk, with high-risk devices subject to stricter oversight. The US applies a more flexible approach, allowing multiple submission pathways and incorporating a focus on continuous learning. The Republic of Korea emphasizes possibilities of streamlined approval and with growing use of real-world data to support validation. Developers must ensure regulatory alignment early in the development process, focusing on key aspects like dataset quality, transparency, and continuous monitoring. Across all regions, the need for technical documentation, quality management systems, and bias mitigation are essential for approval. Developers are encouraged to adopt adaptable strategies to comply with evolving regulatory standards, ensuring models remain transparent, fair, and reliable. The EU’s comprehensive AI Act enforces stricter oversight, while the US and Korea offer more flexible pathways. Developers of spine surgery AI/ML devices must tailor development strategies to align with regional regulations, emphasizing transparent development, quality assurance, and postmarket monitoring to ensure approval success.

Purpose: 11C-Methionine PET/CT is a promising method for detecting parathyroid lesions in patients with primary hyperparathyroidism (PHPT). We aimed to determine the diagnostic ability and correlation of digital 11C-Methionine PET/CT for parathyroid lesions in patients with PHPT, particularly in cases where standard imaging methods yielded inconclusive results. Methods: This retrospective analysis was conducted on patients diagnosed with PHPT who underwent digital 11C-Methionine PET/CT imaging because of ambiguous results on standard imaging work-up ( 99m Tc-MIBI parathyroid scan and/or neck ultrasonography). Quantitative 11C-Methionine PET/CT parameters, including maximum standardized uptake value (SUVmax), mean SUV (SUVmean), peak SUV (SUVpeak), parathyroid methionine volume (PMV), and whole methionine uptake(WMU: PMV multiplied by SUVmean) were calculated with various thresholds, and their correlations with biochemical andpathologic parameters were investigated. Results: This study included 22 consecutive patients (10 men and 12 women) with a median age of 64.0 years. The lesion detection rate and sensitivity of digital 11C-Methionine PET/CT were 81.8% (18/22) and 100.0% (18/18), respectively.Quantitative analysis revealed that serum PTH (r = 0.490, P = 0.039) and serum calcium (r = 0.583, P = 0.011) were signifi-cantly correlated with PMV50%. Conclusion Digital 11C-Methionine PET/CT offers good performance in the detection of parathyroid lesions in PHPT patients with inconclusive standard imaging work-up. The volume parameter of PMV50% significantly correlated biochemi-cal parameters and can serve as a complementary diagnostic tool.

It is difficult to determine a cause of bile duct stricture and dilatation. Eosinophilic cholangitis, a rare benign condition, may be one cause of bile duct stricture and dilatation. It can be evaluated using various methods of histopathology, radiographs, endoscopy, and hematologic findings. Treatment generally involves steroid therapy which can lead to improvement. This case report will discuss eosinophilic cholangitis, emphasizing that while it can easily be overlooked but should be considered in differential diagnoses.

This paper analyzes the regulatory frameworks for artificial intelligence/machine learning AI/ML-enabled medical devices in the European Union (EU), the United States (US), and the Republic of Korea, with a focus on applications in spine surgery. The aim is to provide guidance for developers and researchers navigating regulatory pathways. A review of current literature, regulatory documents, and legislative frameworks was conducted. Key differences in regulatory bodies, risk classification, submission requirements, and approval pathways for AI/ML medical devices were examined in the EU, US, and Republic of Korea. The EU AI Act (2024) establishes a risk-based framework, requiring regulatory review based on device risk, with high-risk devices subject to stricter oversight. The US applies a more flexible approach, allowing multiple submission pathways and incorporating a focus on continuous learning. The Republic of Korea emphasizes possibilities of streamlined approval and with growing use of real-world data to support validation. Developers must ensure regulatory alignment early in the development process, focusing on key aspects like dataset quality, transparency, and continuous monitoring. Across all regions, the need for technical documentation, quality management systems, and bias mitigation are essential for approval. Developers are encouraged to adopt adaptable strategies to comply with evolving regulatory standards, ensuring models remain transparent, fair, and reliable. The EU’s comprehensive AI Act enforces stricter oversight, while the US and Korea offer more flexible pathways. Developers of spine surgery AI/ML devices must tailor development strategies to align with regional regulations, emphasizing transparent development, quality assurance, and postmarket monitoring to ensure approval success.

Purpose: 11C-Methionine PET/CT is a promising method for detecting parathyroid lesions in patients with primary hyperparathyroidism (PHPT). We aimed to determine the diagnostic ability and correlation of digital 11C-Methionine PET/CT for parathyroid lesions in patients with PHPT, particularly in cases where standard imaging methods yielded inconclusive results. Methods: This retrospective analysis was conducted on patients diagnosed with PHPT who underwent digital 11C-Methionine PET/CT imaging because of ambiguous results on standard imaging work-up ( 99m Tc-MIBI parathyroid scan and/or neck ultrasonography). Quantitative 11C-Methionine PET/CT parameters, including maximum standardized uptake value (SUVmax), mean SUV (SUVmean), peak SUV (SUVpeak), parathyroid methionine volume (PMV), and whole methionine uptake(WMU: PMV multiplied by SUVmean) were calculated with various thresholds, and their correlations with biochemical andpathologic parameters were investigated. Results: This study included 22 consecutive patients (10 men and 12 women) with a median age of 64.0 years. The lesion detection rate and sensitivity of digital 11C-Methionine PET/CT were 81.8% (18/22) and 100.0% (18/18), respectively.Quantitative analysis revealed that serum PTH (r = 0.490, P = 0.039) and serum calcium (r = 0.583, P = 0.011) were signifi-cantly correlated with PMV50%. Conclusion Digital 11C-Methionine PET/CT offers good performance in the detection of parathyroid lesions in PHPT patients with inconclusive standard imaging work-up. The volume parameter of PMV50% significantly correlated biochemi-cal parameters and can serve as a complementary diagnostic tool.

It is difficult to determine a cause of bile duct stricture and dilatation. Eosinophilic cholangitis, a rare benign condition, may be one cause of bile duct stricture and dilatation. It can be evaluated using various methods of histopathology, radiographs, endoscopy, and hematologic findings. Treatment generally involves steroid therapy which can lead to improvement. This case report will discuss eosinophilic cholangitis, emphasizing that while it can easily be overlooked but should be considered in differential diagnoses.