Clinical Evidence Supporting US Food and Drug Administration Clearance of Novel Therapeutic Devices via the De Novo Pathway Between 2011 and 2019.
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ABSTRACT:
SUBMITTER: Johnston JL
PROVIDER: S-EPMC7551221 | biostudies-literature |
REPOSITORIES: biostudies-literature
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| S-EPMC8922201 | biostudies-literature
Project description:ImportanceDe novo hypertensive disorders of pregnancy (HDP) are associated with adverse maternal and offspring outcomes. Heterogeneity among racial and ethnic subgroups may be masked with aggregate reporting of race and ethnicity, such as Asian or Pacific Islander or Hispanic.ObjectiveTo determine patterns in de novo HDP rates among individuals in Asian and Hispanic subgroups with a first live birth in the United States in the period 2011 through 2019.Design, setting, and participantsThis serial cross-sectional analysis used data from 2011 through 2019 for individuals aged 15 to 44 years with singleton first live births obtained from the US National Center for Health Statistics natality database.ExposuresStratification by self-report of maternal race and ethnicity: Hispanic/Latina (overall and Hispanic/Latina subgroups [Central/South American, Cuban, Mexican, and Puerto Rican]), non-Hispanic Asian and Pacific Islander (overall and non-Hispanic Asian subgroups [Asian Indian, Chinese, Filipina, Japanese, Korean, and Vietnamese]), non-Hispanic Black, non-Hispanic White.Main outcomes and measuresDe novo HDP was defined as new-onset hypertension during pregnancy (gestational hypertension or preeclampsia). Age-standardized rates of HDP (per 1000 live births) and respective mean annual percent change in race and ethnicity groups and subgroups were calculated.ResultsAmong 13 238 918 individuals, the mean (SD) age was 26.3 (5.8) years. Overall, HDP rates increased 7.3% per year (95% CI, 6.5%-8.1%), from 57.2 (95% CI, 56.8-57.6) per 1000 live births in 2011 to 99.7 (95% CI, 99.2-100.2) per 1000 live births in 2019. Rates of HDP significantly increased in all racial and ethnic groups and subgroups over the study period. The highest HDP prevalence among non-Hispanic Asian subgroups in 2019 was in Filipina individuals (92.5 [95% CI, 86.3-98.8] per 1000 live births), and the highest among Hispanic/Latina subgroups in 2019 was in Puerto Rican individuals (98.6 [95% CI, 94.2-102.9] per 1000 live births) with significant heterogeneity observed among subgroups across the study period.Conclusions and relevanceRates of HDP among individuals with a singleton first live birth increased in the United States from 2011 to 2019 across all race and ethnicity subgroups, with considerable heterogeneity in HDP rates in non-Hispanic Asian and Hispanic/Latina subgroups.
| S-EPMC9178495 | biostudies-literature
Project description:ImportanceThe marketing of health care devices enabled for use with artificial intelligence (AI) or machine learning (ML) is regulated in the US by the US Food and Drug Administration (FDA), which is responsible for approving and regulating medical devices. Currently, there are no uniform guidelines set by the FDA to regulate AI- or ML-enabled medical devices, and discrepancies between FDA-approved indications for use and device marketing require articulation.ObjectiveTo explore any discrepancy between marketing and 510(k) clearance of AI- or ML-enabled medical devices.Evidence reviewThis systematic review was a manually conducted survey of 510(k) approval summaries and accompanying marketing materials of devices approved between November 2021 and March 2022, conducted between March and November 2022, following the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) reporting guideline. Analysis focused on the prevalence of discrepancies between marketing and certification material for AI/ML enabled medical devices.FindingsA total of 119 FDA 510(k) clearance summaries were analyzed in tandem with their respective marketing materials. The devices were taxonomized into 3 individual categories of adherent, contentious, and discrepant devices. A total of 15 devices (12.61%) were considered discrepant, 8 devices (6.72%) were considered contentious, and 96 devices (84.03%) were consistent between marketing and FDA 510(k) clearance summaries. Most devices were from the radiological approval committees (75 devices [82.35%]), with 62 of these devices (82.67%) adherent, 3 (4.00%) contentious, and 10 (13.33%) discrepant; followed by the cardiovascular device approval committee (23 devices [19.33%]), with 19 of these devices (82.61%) considered adherent, 2 contentious (8.70%) and 2 discrepant (8.70%). The difference between these 3 categories in cardiovascular and radiological devices was statistically significant (P < .001).Conclusions and relevanceIn this systematic review, low adherence rates within committees were observed most often in committees with few AI- or ML-enabled devices. and discrepancies between clearance documentation and marketing material were present in one-fifth of devices surveyed.
| S-EPMC10323702 | biostudies-literature
Project description:Agricultural sector plays a key role towards achieving healthier diets that are deemed critical for improving health and nutritional outcomes. To what extent the current food supply systems support healthy diets remains unknown. Using annual and nationally representative data on crop and livestock production in Ethiopia, we assess the national agricultural sector from a nutrition lens and its role in supporting healthy diets in the country. We do so by converting the agricultural production into energy and nutrients for the period of 2011-2015. These data show that the national food production has increased dramatically over the 5-year period to supply more than 3,000 calories per capita in 2015. Moreover, nutrient production gaps have substantially decreased (2011-15), but deficits in energy (5%), vitamin C (16%), and calcium (9%) production remained in 2015. However, this production growth-coming primarily from the cereal sector and at the expense of other food groups-led to a decrease in production diversity as reflected by a drop in the Shannon index between 2011 and 2015. Together these findings imply that the production increases in Ethiopia would need to be sustained to feed the rapidly growing population but more emphasis should be given to diversification to support healthy and nutritionally diversified diets.
| S-EPMC6413914 | biostudies-literature
Project description:Mechanisms underlying the central regulation of food intake and fat accumulation are not fully understood. We found that neurosecretory protein GL (NPGL), a newly-identified neuropeptide, increased food intake and white adipose tissue (WAT) in rats. NPGL-precursor gene overexpression in the hypothalamus caused increases in food intake, WAT, body mass, and circulating insulin when fed a high calorie diet. Intracerebroventricular administration of NPGL induced de novo lipogenesis in WAT, increased insulin, and it selectively induced carbohydrate intake. Neutralizing antibody administration decreased the size of lipid droplets in WAT. Npgl mRNA expression was upregulated by fasting and low insulin levels. Additionally, NPGL-producing cells were responsive to insulin. These results point to NPGL as a novel neuronal regulator that drives food intake and fat deposition through de novo lipogenesis and acts to maintain steady-state fat level in concert with insulin. Dysregulation of NPGL may be a root cause of obesity.
| S-EPMC5553934 | biostudies-literature
Project description:ImportanceMedical Device Safety Communications (MDSCs) are used by the US Food and Drug Administration (FDA) to convey important new safety information to patients and health care professionals. The sources of initial safety signals that trigger MDSCs have not been described previously.ObjectiveTo assess the sources of initial safety signals that trigger publication of MDSCs and the potential associations among MDSC data source, type of safety issue, and subsequent FDA action.Design, setting, and participantsIn this cross-sectional study, all MDSCs published on the FDA website between January 1, 2011, and December 31, 2019, were assessed. The MDSC characteristics, sources of initiating safety signals, regulatory approval or clearance pathways of the related medical devices, and subsequent FDA actions were collected from the FDA website.Main outcomes and measuresThe main outcome was the distribution of sources of initial safety signals that led to publication of MDSCs. Secondary aims included exploration of potential associations among safety signal sources (direct reporting vs other), type of safety issue (death vs other), and FDA action (withdrawal vs other).ResultsA total of 93 MDSCs were evaluated. Median time from device approval to MDSC posting was 10 years (interquartile range, 6-16 years). The most common data sources that triggered MDSCs were direct reports to the FDA through the Medical Device Reporting (MDR) program (44 of 93 [47%]) followed by regulator-initiated assessments (32 [34%]). Common safety issues included patient injury (25 [27%]), potential wrong diagnoses (19 [20%]), and death (18 [19%]). Frequent FDA action after MDSC posting included recommendation for increased vigilance and caution (47 [51%]), complete device withdrawal (12 [13%]), and warnings of specific lots or clinics (12 [13%]). There was a statistically significant correlation between direct reports of adverse events to the FDA through the MDR program and risk of death as a safety issue (14 of 44 [32%] for direct reporting vs 4 of 49 [8%] for any other data sources, P = .007).Conclusions and relevanceIn this cross-sectional study, the most common source of initial safety signals that triggered MDSCs was direct reports of real-world adverse events to the FDA through the MDR program. The delayed detection of postmarketing adverse events highlights the importance of proactive identification of emerging device-related safety issues.
| S-EPMC7522775 | biostudies-literature
Project description:Recent advances in computational protein design now enable the massively parallel de novo design and experimental characterization of small hyperstable binding proteins with potential therapeutic activity. By providing experimental feedback on tens of thousands of designed proteins, the design-build-test-learn pipeline provides a unique opportunity to systematically improve our understanding of protein folding and binding. Here, we review the structures of mini-protein binders in complex with Influenza hemagglutinin and Bot toxin, and illustrate in the case of disulfide bond placement how analysis of the large datasets of computational models and experimental data can be used to identify determinants of folding and binding.
| S-EPMC6001749 | biostudies-literature
Project description:We examine the potential of Kras as a metabolic target in lung cancer using the KrasLSL-G12D lung cancer model. We demonstrate that mutant Kras drives a lipogenic gene expression program, and that fatty acid synthesis is important in Kras-induced tumorigenesis. Compare gene expression changes between mutant Kras (G12D) driven lung tumors and normal lung samples to identify pathways selectively altered in lung tumors.
2018-04-27 | GSE113717 | GEO
Project description:The prospect of phasing diffraction data sets ;de novo' for proteins with previously unseen folds is appealing but largely untested. In a first systematic exploration of phasing with Rosetta de novo models, it is shown that all-atom refinement of coarse-grained models significantly improves both the model quality and performance in molecular replacement with the Phaser software. 15 new cases of diffraction data sets that are unambiguously phased with de novo models are presented. These diffraction data sets represent nine space groups and span a large range of solvent contents (33-79%) and asymmetric unit copy numbers (1-4). No correlation is observed between the ease of phasing and the solvent content or asymmetric unit copy number. Instead, a weak correlation is found with the length of the modeled protein: larger proteins required somewhat less accurate models to give successful molecular replacement. Overall, the results of this survey suggest that de novo models can phase diffraction data for approximately one sixth of proteins with sizes of 100 residues or less. However, for many of these cases, ;de novo phasing with de novo models' requires significant investment of computational power, much greater than 10(3) CPU days per target. Improvements in conformational search methods will be necessary if molecular replacement with de novo models is to become a practical tool for targets without homology to previously solved protein structures.
| S-EPMC2631639 | biostudies-literature
Project description:Transcription is a fundamental process that mediates the interplay between genetic information and phenotype. Emerging evidence indicates that RNA polymerase II (Pol II) can catalyze transcription using both DNA and RNA templates. It is well established that Pol II initiates de novo transcription on DNA templates. However, it is unclear whether Pol II performs de novo transcription or relies on primers for initiation (primed transcription) on RNA templates. Using potato spindle tuber viroid (PSTVd) as a model, we presented evidence showing that circular PSTVd templates are critical for the synthesis of longer-than-unit-length (-)-strand products, which supports the de novo transcription based on the asymmetric rolling circle model of PSTVd replication. We further showed that the crucial factor for primed transcription, transcription factor IIS (TFIIS), is dispensable for PSTVd replication in cells. Together, our data support the de novo transcription on PSTVd RNA templates catalyzed by Pol II. This result has significant implications in understanding the mechanism and machinery underlying Pol II-catalyzed transcription using other RNA templates.
| S-EPMC7232335 | biostudies-literature