Medical Device & IVD Blog
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.
MDCG 2021-5 Rev.1 EU REP Symbol Transition Guide
A regulatory guide to the MDCG 2021-5 Rev.1 EU REP symbol transition, mapping OJEU decisions, Swiss and UK representative rules, and QMS timelines.
Edwards Lifesciences Global Medical Device Registrations Dossier
A global registry dossier for Edwards Lifesciences, analyzing medical device registrations across US FDA, Canada MDALL, Australia ARTG, EU EUDAMED, and other major markets.
Johnson & Johnson MedTech Global Medical Device Registrations Dossier
A global registry dossier for Johnson & Johnson MedTech, analyzing medical device registrations across US FDA, Canada MDALL, Australia ARTG, EU EUDAMED, and other major markets.
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.
BD (Becton, Dickinson) Global Medical Device Registrations Dossier
A global registry dossier for Becton, Dickinson and Company (BD), analyzing medical device registrations across 25 non-US markets and the integration of CareFusion and C.R. Bard.
GE HealthCare
A global registry dossier for GE HealthCare, analyzing medical device registrations across 24 non-US markets and regional representative structures.
Morocco AMMPS Medical Device Establishment Teardown: 171 Declared Entities
An analysis of Morocco's AMMPS list of 171 declared medical device establishments, exploring why MNCs enter via local partners and Law 10.22 changes.
Stryker Global Medical Device Registrations Dossier
A global registry dossier for Stryker Corporation, analyzing medical device registrations across 23 non-US markets and the integration of major acquisitions like Howmedica and Wright Medical.
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.
Zimmer Biomet Global Medical Device Registrations Dossier
A global registry dossier for Zimmer Biomet, analyzing medical device registrations across 24 non-US markets and the integration of Zimmer Holdings and Biomet.
Chile ISP Registered Devices Teardown & Channel Map
A registry analysis of the 619 devices registered under Chile's ISP decree-controlled families, covering condom and syringe category skews, manufacturer countries, and titular concentration.
Oman MOH Registered Devices Teardown & Class C/D Transition
A data teardown of the 502 medicated devices on the Oman MOH register, detailing the dermatology and ophthalmology category skews, local agent concentration, and the new Class C/D mandate.
Pakistan DRAP Registered Medical Devices Teardown & 2025 Ramp
A quantitative analysis of the 12,666 medical devices registered under Pakistan's DRAP, detailing the Class A-D splits, local-vs-import manufacturer mix, and the 2025 registration surge.