United States
457 articles
Why FDA or CE Clearances Fail to Register Aesthetic Devices in China, Korea, and Brazil
A deep regulatory analysis of aesthetic device classification and registration pathway divergence across the US, EU, China, South Korea, and Brazil, mapping sequencing strategies and all-in costs.
Why One FDA/CE Clearance Opens Far Fewer CGM Markets: The Global Class-Divergence Map
A comprehensive cross-market analysis of continuous glucose monitor (CGM) classification, clinical trial requirements, and reimbursement gates across the US, EU, China, Japan, and Canada.
How to Get FDA to Tell You Which Center Will Regulate Your Product: The Pre-RFD Playbook
A comprehensive regulatory guide to FDA's Pre-Request for Designation (Pre-RFD) process for borderline and combination products under the revised November 2025 guidance.
How Generative AI Now Picks Medical Devices for Hospital Procurement
Discover how Value Analysis Committees and hospital procurement teams use generative AI to source devices, and why off-site evidence footprints dominate AI recommendations.
US Medical Device Imports Teardown: Why Mexico — Not China — Is America's #1 Source
A data-driven teardown of US medical device imports using the CEPII BACI dataset, analyzing the difference between core devices and the PPE/consumables basket.
NIH SBIR/STTR Medical Device Funding Teardown: Winners and the Phase I to II Funnel
A deep dive into $2.97B in NIH SBIR/STTR medical device R&D grants. Analyze Phase I vs Phase II funding, repeat winners, geographic hubs, and grant strategy.
US Federal Medical Device Procurement Teardown: Who Wins VA, DoD, and HHS Contracts
A data-driven analysis of $37.6B in federal medical device contracts. Learn which agencies buy, which suppliers win, and how to navigate VA, DoD, and HHS procurement channels.
The US Public Medical Device Company Universe by SEC SIC Code and State
A structural analysis of 1,273 SEC-registered medtech companies by SIC sector and state. Explore industry clustering, sector-value asymmetry, and geographic opportunity corridors.
Continuous Glucose Monitor FDA Recalls & MAUDE: Dexcom & Abbott Teardown
An in-depth analysis of continuous glucose monitor (CGM) recalls and MAUDE safety data, comparing Dexcom and Abbott sensor, receiver, and software failures.
CT, MRI & Fluoroscopy FDA Recalls: Siemens, Philips & GE Teardown
A safety teardown of CT, MRI, and fluoroscopy recalls. We review Siemens, Philips, and GE recall volumes, magnet venting risks, and cybersecurity issues.
FDA Medical Device Product Codes: Analysis of 7,075 Classification Codes
A data-driven analysis of the FDA Medical Device Classification Database. We parse 7,075 product codes by class, specialty panel, and submission type.
FDA Anesthesia Machine Recalls: GE, Dräger & Getinge MAUDE Teardown
A manufacturer-spanning teardown of FDA anesthesia system recalls and MAUDE adverse events, analyzing GE Carestation, Dräger Atlan, and Getinge Flow.
FDA Heart Valve Recalls: Edwards, Medtronic & Abbott MAUDE Teardown
A manufacturer-spanning teardown of FDA heart valve recalls and MAUDE database adverse events, analyzing Class I events and common failure modes.
FDA OTC Hearing Aid Regulation: Product Codes & MAUDE Adverse Events
A comprehensive B2B regulatory guide to the FDA OTC hearing aid framework. Details product codes, 510(k) exemptions, conditions for sale, and MAUDE data.
Disposable Circumcision Devices: FDA 510(k) Pathways & Clinical Evidence
An in-depth regulatory and clinical analysis of disposable circumcision devices (staplers, clamps, and rings), detailing FDA product codes, clinical trials, and market entry due diligence.
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.