European Union

EU Commission's May 2026 draft Article 6 high-risk AI classification guidelines: two-path system for medical devices, consultation deadline June 23, and compliance deadlines in 2027-2028.

RunSafe's 2026 Index: 56% of hospitals reject devices over cybersecurity, 35% won't buy without an SBOM, and 84% include security in RFPs. What manufacturers must do now.

Software verification vs validation for medical devices — FDA expectations, IEC 62304 activities, documentation, traceability, and the design control process.

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 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 roadmap, EU phase-out plan, ISO 10993-5/-10/-23 in vitro alternatives, chemical characterization, and regulatory strategy.

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.

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

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.

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.

Review Haemonetics' Vivasure acquisition, PerQseal Elite bioabsorbable closure technology, PMA pathway, CE Mark status, ELITE data, and large-bore closure competition.

Analysis of Boston Scientific's $14.5B Penumbra acquisition, including CAVT technology, STORM-PE evidence, neurovascular re-entry, competitive impact, and thrombectomy market strategy.

Regulatory guide to connected autoinjectors and smart pens, covering FDA 510(k), De Novo, EU MDR classification, SaMD accessory issues, cybersecurity, and human factors.