FDA 510(k) Submission Generator Skill
Automated 510(k) premarket notification preparation for generating submission packages, predicate device comparisons, and substantial equivalence arguments
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Automated 510(k) premarket notification preparation for generating submission packages, predicate device comparisons, and substantial equivalence arguments
Design Failure Mode and Effects Analysis (DFMEA) skill for systematic design risk identification
Structures bariatric surgery evaluation with insurance requirements, preoperative optimization, and post-surgical nutrition protocols. Use when evaluating bariatric candidates, documenting insurance criteria, or managing post-bariatric care.
Perform pre-experiment calculations and generate step-by-step preparation protocols for dilutions, solution preparation, dissolution, and % concentrations when planning formulations and lab prep workflows.
Simplify informed consent documents into patient-friendly language while maintaining regulatory compliance (FDA 21CFR50, ICH-GCP, HIPAA) and required legal elements.
AI-powered circulating tumor DNA dynamics analysis for molecular residual disease detection, treatment response monitoring, and early relapse prediction using liquid biopsy.
AI-powered cytokine release syndrome (CRS) and cytokine storm analysis for prediction, monitoring, and management in immunotherapy and infectious disease.
Literature mining agent v2.0.0 for novel drug discovery:
AI-powered analysis of hemoglobin disorders including sickle cell disease, thalassemias, and variant hemoglobins using HPLC, electrophoresis, and molecular data.
AI-powered analysis for predicting optimal immune checkpoint inhibitor combinations based on tumor microenvironment, biomarkers, and molecular profiling.
AI-driven pharmacogenomic analysis for precision dosing and adverse event prediction using multi-omics data.
AI-powered homologous recombination deficiency (HRD) analysis for PARP inhibitor response prediction using genomic scarring signatures and BRCA pathway assessment.
AI-powered adeno-associated virus (AAV) vector design for gene therapy including capsid engineering, promoter selection, and tropism optimization.
Precision Oncology
Convert medical laboratory values between units (mg/dL to mmol/L, etc.) with formula transparency and clinical reference ranges. Supports glucose, cholesterol, creatinine, and hemoglobin conversions.
Convert written medical content into podcast or video scripts optimized
Add accurate, publication-ready scale bars to microscopy images given pixel-to-unit calibration data.
Medical document OCR processing for extracting structured clinical data from medical images (prescriptions, lab results, clinical notes). Uses Google Cloud Vision for text extraction and medical NLP for entity recognition. Deploy when processing healthcare documents, extracting patient data, or c...
Expert-level medicinal chemistry knowledge. Use when working with drug design, structure-activity relationships, ADMET properties, pharmacophores, lead optimization, target identification, drug metabolism, or pharmaceutical development. Also use when the user mentions 'SAR', 'drug design', 'pharm...
Comprehensive structural variant (SV) analysis skill for clinical genomics. Classifies SVs (deletions, duplications, inversions, translocations), assesses pathogenicity using ACMG-adapted criteria, evaluates gene disruption and dosage sensitivity, and provides clinical interpretation with evidenc...
Skill for curating cancer and neoplastic disease entries in the dismech knowledge base. Use this skill when creating or enhancing cancer entries, adding oncogene/tumor suppressor pathophysiology, curating histopathology findings, adding targeted therapy information, and linking genetic drivers to...
Abstracts cancer cases for registry submission with required data elements and coding standards. Use when abstracting cancer cases, coding registry data, or documenting cancer reporting.
Creates procedure-specific discharge instructions with activity restrictions, wound care, and return precautions. Use when writing post-surgical discharge instructions, creating patient education materials, or documenting surgical aftercare.
Structures ED visit documentation with chief complaint, MDM, and disposition rationale. Use when charting emergency visits, documenting medical decision-making, or creating ED notes.
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