MedDeviceGuide — IVD & Medical Device Knowledge Base

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 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 analysis covering the first continuous glucose-ketone sensor, dual-analyte regulatory strategy, CGM competition, FDA pathway, and wearable convergence.

Guide to EU Digital Product Passport requirements for medical devices, including ESPR scope, battery passports, UDI/EUDAMED links, standards, and timelines.

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's 2026 NeuWave acquisition pairs Epione robotic ablation with microwave ablation technology under Precision IO Group for interventional oncology.

Swissmedic 2026 PMS focus campaign guide for Class IIa, IIb, and III devices, covering PMS plans, PSURs, PMCF data, complaints, trend analysis, and preparation.

Analysis of Thermo Fisher's $1.1B microbiology divestiture to Astorg, including deal terms, Oxoid and Remel assets, $645M revenue, and diagnostics strategy.

Guide to mandatory EUDAMED registration from May 28, 2026, including actor registration, UDI/device data, certificate linkage, legacy device deadlines, and action steps.

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.

Analyze the March 2026 Handala wiper attack on Stryker, its global manufacturing and order disruption, supply chain impact, and cybersecurity lessons for medtech.

Guide to FDA's TEMPO pilot for digital health devices, enforcement discretion, real-world evidence, CMS ACCESS alignment, eligibility, and key dates.

Analysis of the FTC injunction blocking Edwards' JenaValve acquisition, the TAVR-AR innovation market theory, court ruling, and medtech M&A implications.

Analysis of Waters' $18.8B BD Biosciences combination, covering deal structure, analytical platforms, diagnostics synergies and impact on device and IVD manufacturers.

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.

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.

Stryker's $4.9B Inari Medical acquisition adds FlowTriever and ClotTriever platforms. Review deal structure, VTE thrombectomy competition, FDA pathways, and commercialization impact.

Analysis of DePuy Synthes' Gemtrack RF tracking deal, including VELYS strategy, competition with Mako and ROSA, J&J portfolio options, orthopedic robotics growth, and regulatory considerations.

Analysis of the IV-to-subcutaneous shift in biologics, covering on-body delivery systems, OBDS combination product pathways, human factors, and market drivers.

Analysis of Olympus's $270M BioProtect acquisition, including balloon spacer technology, prostate cancer radiation use, FDA 510(k) strategy, competitors, and commercialization impact.