Reimbursement & Market Access
173 articles
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.
Ukraine DLS Medical Device Register Teardown: Germany-First Supply Map
A comprehensive data teardown of Ukraine's State Service on Medicines and Drugs Control (DLS) medical device register, analyzing source countries, conformity frameworks, and wartime rules.
Angola ARMED Healthcare Establishment Teardown: 3,692 Licensed Operators
A quantitative teardown of Angola's ARMED registry of 3,692 licensed healthcare establishments, analyzing the importer-distributor split and Luanda's logistics dominance.
Cuba CECMED Medical Device Registry Teardown: 4,739 Registrations
A quantitative teardown of Cuba's CECMED medical device registry of 4,739 approved registrations, analyzing the mix of global suppliers, local biotech institutes, and clinical specialties.
Ivory Coast AIRP Medtech Importer Teardown: 658 Approved Wholesalers
A quantitative teardown of Côte d'Ivoire's AIRP registry of 658 approved medtech establishments, analyzing the hyper-concentration in Abidjan and WAEMU market-access routes.
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.
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.
EU Medical Device Procurement & TED Tenders by the Numbers (2026)
A deep quantitative teardown of EU public medical device tenders on Tenders Electronic Daily (TED). Analysis of CPV 331 notice trends, country concentrations, contract values, and top suppliers.
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.
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.
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.
France Medical Device Distributor Landscape & Market-Entry Selection (2026)
A data-driven analysis of the French medical device distributor landscape based on the SNITEM registry, detailing segment mix, focus areas, and selection strategies.
Germany Medical Device Distributor Landscape & Market-Entry Selection (2026)
A data-driven analysis of the German medical device distributor landscape based on the BVMed registry, detailing role types, product categories, and selection strategies.
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.
Saudi Arabia SFDA Registered Devices Teardown & Channel Map
A database teardown of the 163,185 medical devices registered under Saudi Arabia's SFDA, detailing MDMA risk class splits, manufacturer concentration, and AR lock-in risks.
Algeria MIPH Medical Device Import Teardown: 327 Approved Importers
A quantitative teardown of Algeria's MIPH list of 327 approved medical device importers, analyzing the SARL-dominated legal mix and Decree 24/22 reforms.