United States
457 articles
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.
Ultrasound Probe Repair vs Replace: An HTM Decision Framework With MAUDE Evidence
A detailed guide for HTM and biomedical engineering teams to evaluate whether to repair or replace diagnostic ultrasound transducers based on failure modes, safety risks, and compliance.
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.
Custom-Made Medical Devices Under EU MDR: Annex XIII and the FDA Exemption
A complete guide to custom-made medical devices under EU MDR Annex XIII. Learn about the manufacturer statement, MDCG 2021-3, and FDA CDE comparison.
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.
DexCom Global Regulatory Footprint: G7, Stelo, and Market Access
An FDA regulatory and manufacturing footprint dossier of DexCom, mapping G7 and Stelo OTC clearances, product codes QBJ and SAF, and market access.
Intuitive Surgical Global Regulatory Footprint: da Vinci & Ion
An FDA regulatory and commercial footprint dossier of Intuitive Surgical, mapping da Vinci and Ion clearances, product codes, and global market access.
US Medical Device Import Dependence: The $14.5B Trade Deficit
A detailed analysis of US medical device import trade flows from 2013 to 2025, detailing the $14.5B core-device deficit and Section 232 tariff risks.
Medical Device Cybersecurity Compared: FDA §524B vs EU MDR/MDCG/CRA
A comprehensive regulatory comparison of medical device cybersecurity requirements under US FDA Section 524B and the EU MDR, MDCG 2019-16, and Cyber Resilience Act (CRA).
Mindray Worldwide Market-Access Footprint: 24-Market Registry Teardown
A comprehensive database analysis detailing Mindray's 6,620 distinct registrations across 24 global markets, including patient monitoring accessories, IVD, and ultrasound segments.