Medical Device & IVD Blog
Dermal Fillers vs Cosmetics vs Medicines: Hong Kong Borderline Classification After GN-00
How Hong Kong classifies injectable dermal fillers at the borderline between medical devices, cosmetics, and medicines — and why the May 2026 GN-00 update matters for your product.
eDHR for Medical Devices: QMSR, Part 11 & Digital Manufacturing (2026)
eDHR implementation guide for medical device manufacturers: QMSR requirements, 21 CFR Part 11, MES integration, ISO 13485, paper-to-digital migration, and inspection readiness.
NAMs for Medical Device Biocompatibility: FDA, EU & ISO 10993 Guide (2026)
NAMs for medical device biocompatibility: FDA roadmap, EU phase-out plan, ISO 10993-5/-10/-23 in vitro alternatives, chemical characterization, and regulatory strategy.
Hong Kong Dermal Filler MDACS Listing Strategy: LRP, Docs, Importers, Procurement
Guide to listing injectable dermal fillers under Hong Kong MDACS after the May 2026 GN-00 update: LRP, technical dossier, importer controls, adverse event reporting, and procurement.
Hong Kong MDACS GN-00 Update: Why Injectable Dermal Fillers Are Now Medical Devices
On 13 May 2026, Hong Kong MDD updated GN-00 to classify injectable dermal fillers as medical devices under MDACS. What changed, why it matters, and what manufacturers must do.
RPM Device Regulatory Pathway: FDA, CMS Reimbursement & EU MDR (2026)
RPM device regulation: FDA classification, CMS 2026 CPT codes (99445, 99470), reimbursement rates, SaMD, EU MDR pathway, and commercialization strategy for connected monitoring devices.
Abbott Libre Duo CE Mark: Dual Glucose-Ketone CGM Strategy (2026)
Abbott Libre Duo CE mark analysis covering the first continuous glucose-ketone sensor, dual-analyte regulatory strategy, CGM competition, FDA pathway, and wearable convergence.
EU Digital Product Passport for Medical Devices: ESPR, Batteries, and UDI
Guide to EU Digital Product Passport requirements for medical devices, including ESPR scope, battery passports, UDI/EUDAMED links, standards, and timelines.
Liquid Biopsy and Multi-Cancer Early Detection (MCED) Tests: FDA, IVDR Regulatory Pathway
Regulatory guide to liquid biopsy and MCED tests, including FDA pathways, Breakthrough designation, companion diagnostics, EU IVDR classification, clinical evidence, and key market players.
Quantum Surgical Acquires NeuWave Medical: Precision IO and Robotic Ablation
Quantum Surgical's 2026 NeuWave acquisition pairs Epione robotic ablation with microwave ablation technology under Precision IO Group for interventional oncology.
Swissmedic 2026 PMS Focus Campaign: What Class IIa/IIb/III Manufacturers Must Prepare Now
Swissmedic 2026 PMS focus campaign guide for Class IIa, IIb, and III devices, covering PMS plans, PSURs, PMCF data, complaints, trend analysis, and preparation.
Thermo Fisher Microbiology Divestiture to Astorg: $1.1B Deal Analysis
Analysis of Thermo Fisher's $1.1B microbiology divestiture to Astorg, including deal terms, Oxoid and Remel assets, $645M revenue, and diagnostics strategy.
EUDAMED Mandatory Registration: May 28, 2026 Deadlines and UDI Steps
Guide to mandatory EUDAMED registration from May 28, 2026, including actor registration, UDI/device data, certificate linkage, legacy device deadlines, and action steps.
Health Canada REP and CESG Digital Submissions for Medical Devices
Prepare for mandatory REP and CESG submissions for Class II-IV medical device licences, including IMDRF ToC format, XML templates, workflow changes, and April 2026 scope.
Stryker Handala Cyberattack 2026: MedTech Supply Chain and Cybersecurity Lessons
Analyze the March 2026 Handala wiper attack on Stryker, its global manufacturing and order disruption, supply chain impact, and cybersecurity lessons for medtech.
FDA TEMPO Pilot for Digital Health Devices and CMS ACCESS
Guide to FDA's TEMPO pilot for digital health devices, enforcement discretion, real-world evidence, CMS ACCESS alignment, eligibility, and key dates.
FTC Blocks Edwards' $945M JenaValve Deal: Medical Device Antitrust
Analysis of the FTC injunction blocking Edwards' JenaValve acquisition, the TAVR-AR innovation market theory, court ruling, and medtech M&A implications.
Waters-BD Biosciences $18.8B Merger: Life Science Tools Deal Guide
Analysis of Waters' $18.8B BD Biosciences combination, covering deal structure, analytical platforms, diagnostics synergies and impact on device and IVD manufacturers.
Boston Scientific-Bolt $900M Deal: IVL Market and FDA Strategy
Analysis of Boston Scientific's up to $900M Bolt Medical acquisition, laser-based IVL technology, FDA 510(k) pathway, RESTORE and FRACTURE trials, Shockwave competition, and calcified artery market.
J&J DePuy Synthes Sale: Orthopedics Divestiture and MedTech Spinoff Guide
Analysis of J&J's DePuy Synthes separation and potential $20B+ sale, covering the 2025-2027 timeline, orthopedics revenue, VELYS robotics, buyer options, and medtech divestiture trends.