Regulatory
529 articles
Endovenous Laser Ablation: Device Strategy, Accessory Clearance & Economic Optimization
A comprehensive guide to endovenous laser ablation (EVLA) device strategy, covering FDA product codes (OCL vs. GEX), CPT procedure volumes, and razor-and-blade economics.
Managing End-of-Service (EOS) Medical Equipment: Lifecycle Risks & HTM Fleet Controls
A data-driven playbook for managing aging multi-brand ultrasound fleets after receiving an OEM End-of-Service (EOS) letter, detailing safety statistics, tender data, and parts planning.
Medical Device Clinical Trials on ClinicalTrials.gov by the Numbers (2026)
A deep quantitative teardown of the ClinicalTrials.gov database for medical devices. Analysis of phase NA dominance, results-reporting compliance, sponsor classes, and decadal growth trends.
Medical Device Right to Repair: What FDA, FTC, and the Docket Record Actually Say
An evidence-based regulatory analysis of the medical device right-to-repair debate, detailing key agency findings, Regulations.gov dockets, and compliance boundaries.
Medical Device Open Payments by the Numbers: $1.20B CMS Teardown (2026)
A deep quantitative teardown of the CMS Open Payments database for medical devices. Analysis of general payments, royalty dominance, specialty concentrations, and top manufacturer footprints.
Single-Use NPWT Devices: FDA Registration, CMS Coding & the Disposable Shift
A comprehensive guide to single-use negative pressure wound therapy (sNPWT) systems, covering FDA product codes, CPT/HCPCS reimbursement, and business strategies.
Ultrasound Board-Level Failure Patterns: An HTM Field Guide to Root-Cause Diagnosis
A comprehensive HTM guide mapping ultrasound console symptoms to board-level failures (PSU, beamformer, motherboard) with FMECA data and repair-vs-replace rules.
EUDAMED Actors by the Numbers: 48,071 Manufacturers, Importers, and ARs (2026)
A deep quantitative teardown of the EUDAMED Actor module. Analysis of role distribution, country concentration, non-EU manufacturer dependencies, and EU Authorised Representative capacity.
FDA De Novo Database Teardown: Grants by Year, Panel, and Pathway (1997-2025)
A deep quantitative teardown of the FDA De Novo database. Analysis of annual grant trends, review timelines, advisory panel distributions, and the strategic cost-benefit of the pathway.
Medical Device Classification Compared: FDA vs EU MDR vs UK vs IMDRF
A comparative guide to medical device risk classification across the US (FDA), EU (MDR), UK (MHRA), and IMDRF frameworks, featuring worked examples of classification divergence.
Coronary & Peripheral Stent Recalls: Boston Scientific, Abbott & Medtronic Teardown
A manufacturer-spanning deep dive into FDA stent recalls and MAUDE adverse event reports. Analyzes 131 recalls, common failure modes, and recent 2025-2026 high-acuity events.
ESU Recalls: ConMed, Stryker, Megadyne & Olympus Surgical-Fire and Burn Teardown
A manufacturer-spanning deep dive into FDA electrosurgical unit (ESU) recalls and MAUDE adverse event reports. Analyzes 640 recalls, surgical fire risks, and QMS implications.
External Defibrillator & AED Recalls: ZOLL, Stryker, Philips & Cardiac Science Teardown
A manufacturer-spanning teardown of automated external defibrillator (AED) and external defibrillator recalls and MAUDE events. Analyzes 373 recalls, common failure modes, and QMS implications.
EU MDR Notified Body Capacity and the 2026-2030 Certificate Expiry Cliff
Data-driven analysis of EU MDR/IVDR certificate expiry timelines, notified body capacity concentration, and manufacturer country exposure using EUDAMED and NANDO data.
Baxter FDA Device Footprint: 510(k), PMA, Recall & Manufacturing Analysis
A comprehensive data-driven regulatory profile of Baxter's FDA clearances, PMA approvals, safety recalls, and manufacturing hubs after the Hillrom acquisition.
Becton Dickinson (BD) FDA Device Footprint: 510(k), PMA, Recall & Manufacturing Analysis
A comprehensive data-driven regulatory profile of Becton Dickinson's FDA clearances, PMA approvals, safety recalls, and manufacturing hubs after the 2026 Waters spin-off.
FDA Ventilator Recalls: Class I Events, MAUDE Deaths & Root-Cause Analysis (2024–2026)
A data-driven analysis of FDA ventilator recalls, MAUDE database adverse events, root-cause categories, and major Class I events from Vyaire, Hamilton, Baxter, and Philips.
FDA 510(k) Predicate Best Practices: Recall History, Creep, and the 2026 QMSR Gate
A regulatory strategy guide analyzing the FDA's predicate-selection best practices, predicate-creep recall risk, and the 2026 QMSR parallel gate.
Hologic Global Footprint: Genius 3D Mammography, Genius AI, and IVD Market Access
An FDA regulatory and market access footprint dossier of Hologic, mapping Genius 3D Mammography PMA P080003, Genius AI clearances, and Panther diagnostics.
ResMed Global Regulatory Footprint: AirSense 11, Smart Comfort AI, and Market Access
An FDA regulatory and market access footprint dossier of ResMed, mapping AirSense 11 and Smart Comfort AI clearances, product codes, and market shares.