Global
186 articles
Recall vs FSCA Compared: FDA 21 CFR 806, EU MDR, Brazil & Thailand
Side-by-side legal-text comparison of medical device field actions: FDA 21 CFR Part 806, EU MDR FSCA/FSN, Brazil RDC 551/2021, and Thailand recall guidance — triggers, timelines, filing objects.
UDI & Labeling Compared: FDA 801/830, EU MDR, Mexico NOM-137 & China
Legal-text comparison of medical device UDI and labeling: FDA 21 CFR Parts 801 & 830, EU MDR Article 27/Annex VI, Mexico NOM-137-SSA1-2025, and China Order 6/2014 — carriers, databases, and language.
Software as a Medical Device (SaMD) Regulation Compared: SFDA, ANVISA, NAFDAC, PPB
Compare how Saudi SFDA MDS-G23, Brazil ANVISA RDC 657/2022, Nigeria NAFDAC and Kenya PPB regulate Software as a Medical Device — definitions, risk classes, and filing routes.
IVD Calibrator Traceability: ISO 17511, EU IVDR, and JCTLM Guide
Metrological traceability for IVD calibrators and control materials under ISO 17511:2020 and EU IVDR Annex I Section 9.3, covering calibration hierarchies, JCTLM resources, and common pitfalls.
ISO 19011:2026: What the Updated Audit Standard Means for Medical Device Manufacturers
ISO 19011:2026 embeds hybrid auditing, digital evidence management, and updated auditor competence across the audit lifecycle — what ISO 13485 and QMSR programs need to update.
Veterinary Medical Device Regulation: FDA CVM, EU Gaps, and Global Strategy
How veterinary medical devices are regulated under FDA CVM, EU frameworks, and key global markets. Covers classification gaps, 510(k) exemptions, off-label use, and market entry strategy.
Medical Device Cybersecurity Is Now a Procurement Gate: 2026 Hospital Buying Data
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.
ISO 13485 Audit Findings: Most Common Nonconformities by Clause and How to Prevent Them
The ISO 13485 clauses most cited in audit findings — root causes and corrective actions for document control, CAPA, design controls, suppliers, internal audits, and process validation.
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.
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.
Stryker Inari Medical $4.9B Deal: VTE Thrombectomy Market Analysis
Stryker's $4.9B Inari Medical acquisition adds FlowTriever and ClotTriever platforms. Review deal structure, VTE thrombectomy competition, FDA pathways, and commercialization impact.
DePuy Synthes Gemtrack RF Tracking Deal: Orthopedic Robotics 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.
IV-to-Subcutaneous Shift: OBDS Regulatory Strategy Guide (2026)
Analysis of the IV-to-subcutaneous shift in biologics, covering on-body delivery systems, OBDS combination product pathways, human factors, and market drivers.
Olympus Acquires BioProtect for $270M: Balloon Spacer Market and Strategy
Analysis of Olympus's $270M BioProtect acquisition, including balloon spacer technology, prostate cancer radiation use, FDA 510(k) strategy, competitors, and commercialization impact.
Abbott-Exact Sciences $21B Deal: Cancer Diagnostics and IVD Strategy
Analysis of Abbott's $21B Exact Sciences acquisition, including Cologuard, Oncotype DX, deal structure, cancer screening IVD strategy, and precision oncology market impact.
Boston Scientific-Nalu $600M Deal: Peripheral Nerve Stimulation Strategy
Analysis of Boston Scientific's $600M Nalu Medical acquisition, battery-free PNS implants, COMFORT trial data, neuromodulation competition, FDA pathway, and chronic pain market shift.
Haemonetics Acquires Vivasure Medical: Vascular Closure Deal Guide
Review Haemonetics' Vivasure acquisition, PerQseal Elite bioabsorbable closure technology, PMA pathway, CE Mark status, ELITE data, and large-bore closure competition.