1.Application value of optimized mesenteric defect closure technique in laparoscopic-assisted right hemicolectomy
Hengrui NIU ; Wenqing HU ; Peng CUI ; Yinhao YANG ; Jie WANG ; Dongyang SONG ; Weifeng LI ; Xiongxiong SONG ; Wei WEI
Chinese Journal of Digestive Surgery 2025;24(5):630-635
Objective:To investigate the application value of optimized mesenteric defect closure technique in laparoscopic-assisted right hemicolectomy.Methods:The retrospective and descriptive study was conducted. The clinicopathological data of 26 patients who underwent laparo-scopic-assisted right hemicolectomy at Changzhi People′s Hospital Affiliated to Changzhi Medical College from May 2023 to June 2024 were collected. There were 11 males and 15 females, aged (65.7±1.8)years. All patients received optimized mesenteric defect closure using a combined extra-corporeal-laparoscopic suturing technique. Observation indicators: (1) surgical and intraoperative conditions; (2) postoperative conditions; (3) follow-up. Measurement data with normal distribution were represented as Mean± SD, and measurement data with skewed distribution were represented as M( Q1, Q3) or M(range). Count data were described as absolute numbers. Results:(1) Surgical and intraoperative conditions. All 26 patients underwent laparoscopic-assisted right hemicolectomy with optimized mesenteric defect closure. The time of optimized mesenteric defect closure was 9.8(8.8,12.8)minutes, time of digestive tract reconstruction was 10.0(8.7,13.0)minutes, operation time was (164±4)minutes, volume of intraoperative blood loss was 50(50,100)mL. One of the 26 patients had intraoperative mesenteric hematoma, which required no specific intervention. The patient recovered uneventfully and was discharged from hospital. (2) Postoperative conditions. The visual analog scale pain score of 26 patients on postoperative day 1 and day 3 were 5(4,5) and 3(2,3), respectively. Time to postoperative first anal flatus and bowel movement were both 3(3, 4)days. Time to postoperative first intake of liquid diet was 2(2,3)days, duration of postoperative abdominal drainage was 4(3,5)days, and duration of postoperative hospital stay was 9(8,12)days. The number of lymph node dissected in 26 patients was 25(18,27) and the number of positive lymph node was 1(0,2). Cases in stage Ⅰ, stage Ⅱ and stage Ⅲ of tumor TNM staging were 5, 6, 15. (3) Follow-up. All 26 patients were followed up for 15(range, 6?20)months. Of the 26 patients, one case had incom-plete intestinal obstruction on postoperative day 25, which was diagnosed as adhesive intestinal obstruction based on imaging examination and classified as Clavien-Dindo grade Ⅱ. The patient recovered and was discharged after conservative treatment. None of the 26 patients had bleeding, infection of incision, anastomotic leakage, internal hernia, or delayed gastric emptying. There was no tumor recurrence, metastasis or death.Conclusion:The optimized mesenteric defect closure tech-nique in combined extracorporeal-laparoscopic suturing procedure can be used in laparoscopic-assisted right hemicolectomy.
2.A randomized controlled trial on the efficacy of compound polyethylene glycol electrolyte powder com-bined with linaclotide for bowel preparation in elderly constipated patients before colonoscopy
Jianjun ZHANG ; Haipeng WANG ; Guangfeng DONG ; Ming CHEN ; Jinqi LIU ; Hao ZHANG ; Mingjuan SUN ; Meng LU ; Huizhuan ZHAI ; Xingguang HUANG ; Zengjun LI ; Dongyang WANG
The Journal of Practical Medicine 2025;41(19):2967-2971
Objective To evaluate the efficacy and safety of polyethylene glycol electrolyte powder(PEG)combined with linaclotide(Lin)for bowel preparation in elderly constipated patients before colonoscopy.Methods In this prospective,randomized controlled trial,90 elderly patients with constipation undergoing colonoscopy were recruited at our hospital from June 2022 to December 2023.Participants were randomly assigned to three groups(n=30 each):PEG-3L alone,PEG-3L+Lin,and PEG-2L+Lin.Primary outcome was Boston Bowel Preparation Scale(BBPS)score and secondary outcomes included adverse event rates,colonoscopy completion rate,withdrawal time,and polyp detection rate.Statistical analysis was performed using independent t-tests and chi-square tests.Results The PEG-3L+Lin group achieved significantly higher BBPS scores than both PEG-3L alone and PEG-2L+Lin groups did(both P<0.001).The PEG-2L+Lin group also outperformed the PEG-3L alone group in cleansing efficacy(90.0%vs.76.7%,P=0.008).The PEG-2L+Lin group demonstrated the best tolerability and lowest adverse event rate,the PEG-3L group had the longest withdrawal time(P<0.05),but the three groups showed no significant difference in polyp detection rates.Conclusion PEG combined with linaclotide significantly improves bowel cleansing in elderly constipated patients.PEG-2L+Lin regimen provides optimal balance between efficacy,safety,and tolerability,making it a preferable choice for this population.
3.Safety and efficacy of different anastomotic techniques following proximal gastrectomy: a meta-analysis
Dongyang SONG ; Zehua WANG ; Jie WANG ; Jinjie ZHANG ; Shasha LI ; Kun ZHANG ; Guohua GAO ; Wenqing HU
Chinese Journal of Gastrointestinal Surgery 2025;28(10):1179-1193
Objective:This meta-analysis compares the postoperative outcomes of the double-flap technique (DFT) versus esophagogastrostomy (EG), jejunal interposition (JI), double-tract reconstruction (DTR), and gastric tube anastomosis (GTA) following proximal gastrectomy for gastric cancer.Methods:Prospective and retrospective studies published from database inception until June 2025 were retrieved from PubMed, Embase, Web of Science, Scopus, CNKI, and Wanfang databases. Studies reporting at least one predefined outcome with extractable data were included. Outcomes of interest consisted of incidence of gastroesophageal reflux, overall postoperative complications, anastomotic leakage, anastomotic stenosis, and digestive reconstruction time. Two investigators independently performed literature screening, data extraction, and quality assessment. Randomized controlled trials (RCTs) were evaluated with the Cochrane ROB 2.0 tool, retrospective cohort studies with the Newcastle-Ottawa Scale (NOS), and single-arm studies with the JBI critical appraisal tool. Dichotomous outcomes were pooled using risk ratios (RRs), and continuous variables were summarized with standardized mean differences (SMDs), using fixed- or random-effects models based on I2 statistics. Publication bias was assessed via funnel plots and Egger's test.Results:A total of 55 studies published between 2007 and 2025 were included, comprising 5 RCTs and 50 retrospective studies. Among 4,380 patients, 732 underwent EG, 454 GTA, 1,480 DTR, 468 JI, and 1,246 DFT. Quality assessment indicated that all except six retrospective cohort studies (rated as moderate quality) were of high quality or had low risk of bias. Among the five reconstruction methods, DFT showed the lowest incidence of gastroesophageal reflux (6.6%, 82/1,246) and overall postoperative complications (11.6%, 144/1,246). JI had the lowest rate of anastomotic leakage (1.3%, 6/468), followed by DFT (1.4%, 18/1,246), and DTR had the lowest rate of anastomotic stenosis (2.4%, 36/1,480), followed by DFT (7.5%, 94/1,246). DFT required the longest operative time for reconstruction ([141.2 ± 597.6] minutes), and DTR required the shortest ([50.1 ± 39.0] minutes). Compared to EG, DFT was associated with a significantly lower risk of gastroesophageal reflux (RR=0.13 ,95%CI: 0.03-0.55, P = 0.01), and no significant differences were observed in overall complications (RR=0.98, 95%CI: 0.55-1.74, P = 0.93), anastomotic leakage (RR = 0.81, 95%CI: 0.04-18.43, P = 0.90), or anastomotic stenosis (RR = 0.75, 95%CI: 0.09-6.39, P = 0.79). Compared to JI, DFT showed no significant differences in gastroesophageal reflux (RR = 0.36, 95%CI: 0.10-1.25, P=0.11), overall complications (RR=2.06, 95%CI: 0.30-14.11, P=0.46), anastomotic leakage (RR=2.05, 95%CI: 0.26-16.18, P=0.49), or anastomotic stenosis (RR=0.83, 95%CI: 0.10-7.17, P=0.87). Similarly, compared to DTR, DFT had a lower risk of overall complications (RR=0.70, 95%CI: 0.50-0.98, P=0.04) but a longer reconstruction time (SMD: 2.55, 95%CI: 0.31-4.79, P=0.03). No significant differences were found in gastroesophageal reflux (RR = 0.68, 95%CI: 0.35-1.30, P=0.24), anastomotic leakage (RR=0.59, 95%CI: 0.16-2.17, P=0.43), or anastomotic stenosis (RR=2.44 , 95%CI: 0.44-13.64, P=0.31). Compared to GTA, DFT was associated with a significantly lower risk of gastroesophageal reflux (RR = 0.53, 95%CI: 0.33-0.88, P=0.01), but again there were no significant differences in overall complications (RR = 0.69, 95%CI: 0.41-1.16, P=0.16), anastomotic leakage (RR = 0.25, 95%CI: 0.03-2.14, P=0.21), or anastomotic stenosis (RR=0.65, 95%CI: 0.24-1.76, P=0.40). No significant publication bias was detected in the analysis (Egger's test P>0.05). Conclusions:Among the five common anastomotic methods after proximal gastrectomy, DFT demonstrates superior anti-reflux efficacy, outperforming EG and GTA in particular in preventing gastroesophageal reflux. DFT also exhibits a lower overall complication risk compared with DTR but maintains anastomotic safety comparable with that of the other techniques.
4.Epidemiological characteristics and spatiotemporal distribution of hepatitis C in Henan Province from 2012 to 2022
Lu LIU ; Yugang NIE ; Xiaoyu JI ; Guolong ZHANG ; Yang LIU ; Dongyang ZHAO ; Ning LI
Chinese Journal of Preventive Medicine 2025;59(8):1203-1208
Objective:To analyze the epidemiological characteristics and spatiotemporal distribution of hepatitis C in Henan province from 2012 to 2022.Methods:The case report data on hepatitis C from counties and districts in Henan between 2012 and 2022 were collected. The distribution characteristics were analyzed by descriptive epidemiological methods, and GeoDa1.2 software was used to perform spatial autocorrelation analysis. The spatiotemporal epidemiological analysis was conducted using SaTScan 10.1 software.Results:A total of 274 485 hepatitis C cases were reported in Henan from 2012 to 2022. The reported annual average incidence rate was 25.84/100 000 and showed an overall downward trend from 2012 to 2022 ( Z=-4.05, P<0.001). More cases were reported in women. The cases were mainly aged 40-69 years and farmers. Spatial autocorrelation analysis showed that the reported cases of hepatitis C present spatial clustering during 2012—2022, and the areas with high incidence were mainly distributed in counties or districts of Zhengzhou, Zhumadian, Xuchang, Zhoukou, and Nanyang. One class I clustering area was detected by spatiotemporal scanning, which mainly covered Xuchang, Pingdingshan and the surrounding counties ( LLR=16 117.73, RR=1.81, P<0.001). Conclusion:The reported cases of hepatitis C in Henan Province show an overall downward trend from 2012 to 2022 and present spatiotemporal clustering. The seasonal regularity of the hepatitis C epidemic is not obvious. People aged 40-69 years old and farmers are the key population for prevention and control.
5.Safety and efficacy of different anastomotic techniques following proximal gastrectomy: a meta-analysis
Dongyang SONG ; Zehua WANG ; Jie WANG ; Jinjie ZHANG ; Shasha LI ; Kun ZHANG ; Guohua GAO ; Wenqing HU
Chinese Journal of Gastrointestinal Surgery 2025;28(10):1179-1193
Objective:This meta-analysis compares the postoperative outcomes of the double-flap technique (DFT) versus esophagogastrostomy (EG), jejunal interposition (JI), double-tract reconstruction (DTR), and gastric tube anastomosis (GTA) following proximal gastrectomy for gastric cancer.Methods:Prospective and retrospective studies published from database inception until June 2025 were retrieved from PubMed, Embase, Web of Science, Scopus, CNKI, and Wanfang databases. Studies reporting at least one predefined outcome with extractable data were included. Outcomes of interest consisted of incidence of gastroesophageal reflux, overall postoperative complications, anastomotic leakage, anastomotic stenosis, and digestive reconstruction time. Two investigators independently performed literature screening, data extraction, and quality assessment. Randomized controlled trials (RCTs) were evaluated with the Cochrane ROB 2.0 tool, retrospective cohort studies with the Newcastle-Ottawa Scale (NOS), and single-arm studies with the JBI critical appraisal tool. Dichotomous outcomes were pooled using risk ratios (RRs), and continuous variables were summarized with standardized mean differences (SMDs), using fixed- or random-effects models based on I2 statistics. Publication bias was assessed via funnel plots and Egger's test.Results:A total of 55 studies published between 2007 and 2025 were included, comprising 5 RCTs and 50 retrospective studies. Among 4,380 patients, 732 underwent EG, 454 GTA, 1,480 DTR, 468 JI, and 1,246 DFT. Quality assessment indicated that all except six retrospective cohort studies (rated as moderate quality) were of high quality or had low risk of bias. Among the five reconstruction methods, DFT showed the lowest incidence of gastroesophageal reflux (6.6%, 82/1,246) and overall postoperative complications (11.6%, 144/1,246). JI had the lowest rate of anastomotic leakage (1.3%, 6/468), followed by DFT (1.4%, 18/1,246), and DTR had the lowest rate of anastomotic stenosis (2.4%, 36/1,480), followed by DFT (7.5%, 94/1,246). DFT required the longest operative time for reconstruction ([141.2 ± 597.6] minutes), and DTR required the shortest ([50.1 ± 39.0] minutes). Compared to EG, DFT was associated with a significantly lower risk of gastroesophageal reflux (RR=0.13 ,95%CI: 0.03-0.55, P = 0.01), and no significant differences were observed in overall complications (RR=0.98, 95%CI: 0.55-1.74, P = 0.93), anastomotic leakage (RR = 0.81, 95%CI: 0.04-18.43, P = 0.90), or anastomotic stenosis (RR = 0.75, 95%CI: 0.09-6.39, P = 0.79). Compared to JI, DFT showed no significant differences in gastroesophageal reflux (RR = 0.36, 95%CI: 0.10-1.25, P=0.11), overall complications (RR=2.06, 95%CI: 0.30-14.11, P=0.46), anastomotic leakage (RR=2.05, 95%CI: 0.26-16.18, P=0.49), or anastomotic stenosis (RR=0.83, 95%CI: 0.10-7.17, P=0.87). Similarly, compared to DTR, DFT had a lower risk of overall complications (RR=0.70, 95%CI: 0.50-0.98, P=0.04) but a longer reconstruction time (SMD: 2.55, 95%CI: 0.31-4.79, P=0.03). No significant differences were found in gastroesophageal reflux (RR = 0.68, 95%CI: 0.35-1.30, P=0.24), anastomotic leakage (RR=0.59, 95%CI: 0.16-2.17, P=0.43), or anastomotic stenosis (RR=2.44 , 95%CI: 0.44-13.64, P=0.31). Compared to GTA, DFT was associated with a significantly lower risk of gastroesophageal reflux (RR = 0.53, 95%CI: 0.33-0.88, P=0.01), but again there were no significant differences in overall complications (RR = 0.69, 95%CI: 0.41-1.16, P=0.16), anastomotic leakage (RR = 0.25, 95%CI: 0.03-2.14, P=0.21), or anastomotic stenosis (RR=0.65, 95%CI: 0.24-1.76, P=0.40). No significant publication bias was detected in the analysis (Egger's test P>0.05). Conclusions:Among the five common anastomotic methods after proximal gastrectomy, DFT demonstrates superior anti-reflux efficacy, outperforming EG and GTA in particular in preventing gastroesophageal reflux. DFT also exhibits a lower overall complication risk compared with DTR but maintains anastomotic safety comparable with that of the other techniques.
6.Epidemiological and molecular traceability analysis of the first cluster outbreak of D8 genotype measles in Henan Province
Xiaoxiao ZHANG ; Binghui DU ; Daxing FENG ; Wenhui WANG ; Jing LI ; Lili LIU ; Hui ZI ; Qihua WAN ; Songtao ZHAO ; Xiaoli WANG ; Xiaobo WU ; Yonghao GUO ; Yanyang ZHANG ; Dongyang ZHAO
Chinese Journal of Preventive Medicine 2025;59(8):1294-1298
In February 2025, a local cluster outbreak caused by the D8 genotype Measles virus (MV) was first discovered in Henan Province. Epidemiological investigations and laboratory testing were conducted, including the collection of serum and throat swabs for MV IgM antibody and nucleic acid detection, virus isolation and genetic homology analysis. Measures such as close contact tracing, vaccination rate assessment and supplementary immunization activities were implemented, successfully preventing broader community transmission. A total of three cases were reported during the outbreak, including one imported-related adolescent and two secondary local adult cases. All cases presented with typical symptoms such as fever and rash. Both adult cases were complicated by pneumonia, with one case developing into severe pneumonia. MV genotyping showed that the two secondary cases were both the D8 genotype, with the viral sequences being completely homologous to the Kazakhstan strain. Among the close contacts, 98.2% were adults, and 142 individuals received emergency vaccination.
7.Arthroscopic suture anchor fixation for acute bony Bankart lesions: excellent bone healing with a low complication rate
Qiangqiang LI ; Peng SUN ; Yu ZHANG ; Kai FU ; Yao YAO ; Jianghui QIN ; Jin XIONG ; Qing JIANG ; Dongyang CHEN
Chinese Journal of Orthopaedics 2025;45(8):523-530
Objective:To investigate the clinical outcomes of arthroscopic suture anchor fixation for acute bony Bankart lesions.Methods:Data of 49 patients with acute bone Bankart injury treated with suture anchor fixation under arthroscopy at the Affiliate Nanjing Drum Tower Hospital of Nanjing University School of Medicine from February 2019 to July 2024 were retrospectively analyzed, including 34 males and 15 females, aged 46.4±17.7 years (range, 18-81 years). Body mass index was 26.3±4.2 kg/m 2 (range, 19.8-37.9 kg/m 2). There were 17 patients with left shoulder and 32 patients with right shoulder. The time from injury to operation was 12.6±10.5 d (range, 1-50 d). CT three-dimensional reconstruction showed that the area of bone defect accounted for 20.1%±11.4% (range, 8%-49%) of the glenoid area. According to the degree of bone defect, there were 38 cases in the bone defect area ≤25% group and 11 cases in the bone defect area >25% group. All 49 patients received shoulder arthroscopic fixation with wire anchor. All 49 the patients were treated under shoulder arthroscopy using suture anchor technique. Using American Shoulder & Elbow Surgeon (ASES) score, University of California, Los Angeles (UCLA) score, Rowe score as well as shoulder range of motion to evaluate shoulder function. The position and healing of the fracture mass were evaluated with shoulder joint CT and three-dimensional reconstruction at immediate and final follow-up. Results:The incision healed in one stage and no infection occurred in all patients. All 49 patients were followed up for a period of 3 to 81 months, with an average follow-up of 23.8±20.2 months. At the final follow-up, the mean forward elevation, external rotation, and internal rotation improved from 126.1°±20.3°, 36.9°±14.0°, and 10±2 preoperatively to 167.1°±15.5°, 66.8°±8.3°, and 6±1 at the last follow-up, respectively ( P<0.05). At the final follow-up, the mean ASES score, UCLA score, and Rowe score were all significantly improved from 41.3±11.9, 14.2±6.1 and 46.9±14.7 preoperatively to 89.7±7.8, 31.5±3.6 and 92.4±7.4, respectively ( P<0.05). The differences between the final follow-up and preoperative values for forward elevation in the bone defect area >25% group and the bone defect area ≤25% group were 43°±20° and 41°±21°, respectively. The differences in lateral external rotation were 34°±8° and 29°±18°, while the differences in internal rotation (measured by hand-behind-back reach) were 5±2 and 4±2, respectively. None of these differences were statistically significant. The differences between the final follow-up and preoperative scores in the bone defect area >25% fracture fragment group and the bone defect area ≤25% group were as follows: ASES score, 50.9±14.4 vs. 47.7±12.8; UCLA score, 18.4±3.2 vs. 17.0±6.9; and Rowe score, 40.5±13.5 vs. 46.9±15.0. None of these differences were statistically significant. CT examination at the last follow-up showed that all fractures were healed, all patients in the bone defect area ≤25% group achieved good reduction, and 3 patients in the bone defect area >25% group had step-offs on the glenoid surface. Postoperative shoulder adhesion occurred in 5 patients, which was improved after intensive abduction and external rotation exercise. Conclusions:Arthroscopic suture anchor fixation is effective for the bone defect area ≤25% bony Bankart lesions, offering advantages of minimal invasiveness and rapid recovery. For lesions involving more than the bone defect area 25% of the glenoid surface, enhanced fixation strength is recommended to prevent fracture fragment displacement.
8.Discovery of E0199: A novel compound targeting both peripheral NaV and KV7 channels to alleviate neuropathic pain.
Boxuan ZHANG ; Xiaoxing SHI ; Xingang LIU ; Yan LIU ; Xuedong LI ; Qi WANG ; Dongyang HUANG ; Weidong ZHAO ; Junru CUI ; Yawen CAO ; Xu CHAI ; Jiahao WANG ; Yang ZHANG ; Xiangyu WANG ; Qingzhong JIA
Journal of Pharmaceutical Analysis 2025;15(1):101132-101132
This research study focuses on addressing the limitations of current neuropathic pain (NP) treatments by developing a novel dual-target modulator, E0199, targeting both NaV1.7, NaV1.8, and NaV1.9 and KV7 channels, a crucial regulator in controlling NP symptoms. The objective of the study was to synthesize a compound capable of modulating these channels to alleviate NP. Through an experimental design involving both in vitro and in vivo methods, E0199 was tested for its efficacy on ion channels and its therapeutic potential in a chronic constriction injury (CCI) mouse model. The results demonstrated that E0199 significantly inhibited NaV1.7, NaV1.8, and NaV1.9 channels with a particularly low half maximal inhibitory concentration (IC50) for NaV1.9 by promoting sodium channel inactivation, and also effectively increased KV7.2/7.3, KV7.2, and KV7.5 channels, excluding KV7.1 by promoting potassium channel activation. This dual action significantly reduced the excitability of dorsal root ganglion neurons and alleviated pain hypersensitivity in mice at low doses, indicating a potent analgesic effect without affecting heart and skeletal muscle ion channels critically. The safety of E0199 was supported by neurobehavioral evaluations. Conclusively, E0199 represents a ground-breaking approach in NP treatment, showcasing the potential of dual-target small-molecule compounds in providing a more effective and safe therapeutic option for NP. This study introduces a promising direction for the future development of NP therapeutics.
9.The application prospects, ethical risks, and governance pathways of artificial womb technology
Chinese Medical Ethics 2025;38(5):656-662
The research on artificial womb technology and “fetus and newborn” by Deby et al., as well as the Food and Drug Administration’s discussion on whether the world’s first human clinical trial of “artificial womb” technology should be approved, have sparked a new wave of research on artificial womb technology. By extending and deepening relevant foreign research, the three potential application prospects of artificial womb technology were clarified, including rescuing extremely preterm infants, reducing the burden of pregnancy, and assisting advanced maternal age. The ethical risks it faced were pointed out, encompassing the moral status of the gestational entity was questionable, and the risks of technological experimentation could not be quantified. The governance pathways were clarified, involving multi-layered ethical considerations to complete the clear identification of the gestational entity’s identity, and multi-faceted patient-doctor consultations to achieve clear risk notification. Through discussions on the application prospects, ethical risks, and governance pathways of artificial womb technology can improve human welfare and realize the technology for human use.
10.Advances and future research prospects in regulatory policies for clin-ical trials of artificial intelligence medical devices
Hao LIANG ; Shun WANG ; Cheng CUI ; Ling SONG ; Ailin SUN ; Man LI ; Jie QIAO ; Chun-li SONG ; Haiyan LI ; Yangguang ZHAO ; Haiyan LI ; Chenguang ZHANG ; Dongyang LIU
Chinese Journal of Clinical Pharmacology and Therapeutics 2025;30(3):427-431
Artificial intelligence(AI)has emerged as a cutting-edge technology leading the future and is a key engine for China's development.In the innovation and research of medical devices,AI has provided critical support in the areas of intelligent diagnostic assistance,intelligent therapeutic assis-tance,intelligent monitoring,life support,et al.Ma-chine learning-enabled device software functions(ML-DSFs)have become an essential component of many medical devices.Recently,the United States Food and Drug Administration(FDA)released a draft guidance titled"Marketing Submission Rec-ommendations for a Predetermined Change Con-trol Plan for Artificial Intelligence/Machine Learn-ing(AI/ML)-Enabled Device Software Functions(Draft)."that aimed to provide a forward-looking approach to foster the development of ML medical devices.By supporting iterative updates through modifications,this approach ensures the continu-ous safety and effectiveness of the devices.This guidance represents the latest in regulatory direc-tion and is especially beneficial for enhancing the quality and efficiency of clinical trials for AI prod-ucts.Therefore,we plan to provide a detailed intro-duction and interpretation of the guidance,with the aim of learning from international advanced regulatory concepts and experiences to promote the development of ML-DSFs with more profound international influence.

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