Medical Device & IVD Blog
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.
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.
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.
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.
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.
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.
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.