United States
287 articles
Stryker Acquires Amplitude Vascular Systems: IVL and Peripheral Vascular Strategy
Stryker's May 2026 AVS acquisition adds next-generation IVL for calcified PAD, including the CO2 pressure wave platform, regulatory path, competition, and market impact.
Bayer-Perfuse $2.45B Deal: Ophthalmology Drug-Device Strategy
Analysis of Bayer's up to $2.45B Perfuse Therapeutics acquisition, including the PER-001 intravitreal implant, deal terms, endothelin mechanism, and ophthalmic drug-device convergence.
GE HealthCare Restructuring, Price Hikes, and MedTech Supply Impact
What GE HealthCare's 2026 restructuring, leadership changes, price increases, and $250M inflation hit mean for medtech supply chains and device manufacturers.
Sun Pharma $11.75B Organon Acquisition: Women's Health and Biosimilars
Sun Pharma's $11.75B Organon deal reshapes women's health and biosimilars. Review deal structure, combination-product considerations, portfolio assets, and regulatory impact.
Danaher's $9.9B Masimo Acquisition: Patient Monitoring and Diagnostics Impact
Analysis of Danaher's $9.9B Masimo acquisition, including deal structure, strategic rationale, antitrust considerations, patient monitoring competition, and medtech industry impact.
FDA One-Day AI Inspection Pilot: How Elsa Is Reshaping Medical Device Facility Oversight
Guide to FDA's May 2026 one-day AI inspection pilot using Elsa, including facility selection, screening inspection expectations, differences from standard inspections, and readiness steps.
FDA Real-Time Clinical Trials Pilot for Medical Devices
What device sponsors need to know about FDA's 2026 real-time clinical trials pilot, AI-enabled monitoring, Paradigm Health, and participation readiness.
EPA Ethylene Oxide Rules for Medical Device Sterilization: 2026 Guide
Guide to the EPA's 2026 proposed EtO emissions rollback for medical device sterilization, covering the 2024 rule, compliance timelines, supply chain risk, and alternatives.
Home-Use IVD Invalid Result Workflow for Consumer Diagnostics
Design and monitor invalid-result workflows for home-use IVDs, including invalid rates, lay-user errors, repeat testing, IFU comprehension, support scripts, and postmarket trending.
MDUFA VI: FDA Device User Fees and 2027-2032 Reauthorization
Guide to MDUFA VI for 2027-2032, covering FDA device user fee changes, CDRH staffing, real-world evidence provisions, fee projections, and preparation steps.
NGS Bioinformatics Pipeline Change Control: Documentation and Revalidation Guide
Document NGS bioinformatics pipeline changes, assess validation impact, control software and database updates, and prepare IEC 62304 audit records for IVDs.
RUO-to-IVD Conversion Firewall: Convert Research-Use Assays Without Evidence Risk
Operational guide to converting RUO assays into regulated IVDs, covering claims cleanup, distributor controls, data triage, validation bridging, training, and evidence firewalls.
FDA Workforce Cuts and Medical Device Regulatory Timelines in 2026
How FDA and CDRH staffing reductions may affect 510(k) reviews, pre-submission meetings, MDUFA goals, and regulatory planning for device companies.
GLP-1 Drug Delivery Devices: Combination Product Pathways 2026
Guide to the GLP-1 drug delivery device ecosystem, including auto-injector pens, oral delivery, combination product pathways, FDA, EU MDR, and market outlook.
FDA AI-Enabled Device Software Guidance: TPLC Draft Guide
Guide to FDA's January 2025 draft guidance on AI-enabled device software functions, including TPLC controls, data management, bias mitigation, transparency, and submission content.
Medical Device Regulatory Sandboxes: MHRA AI Airlock and FDA TEMPO
Guide to medical device regulatory sandboxes, including MHRA AI Airlock, FDA TEMPO for digital health, EU proposals, eligibility, participation, and market access benefits.
GCP for Medical Device Clinical Trials: ISO 14155 and ICH E6(R3) in 2026
Apply Good Clinical Practice to medical device trials under ISO 14155:2026 and ICH E6(R3), with sponsor duties, consent, safety reporting, and audit readiness.
Cleaning Validation for Reusable Surgical Instruments: Soil, Residue, and Worst Case
Build cleaning validation protocols for reusable surgical instruments, covering test soils, residue endpoints, worst-case devices, ST98 criteria, sampling, and reports.
CLIA Waiver for IVDs: Submission Strategy, Study Design, and Dual 510(k) Pathway
Plan a CLIA waiver strategy for IVDs, covering complexity categories, CW content, flex and lay-user studies, Dual 510(k) + CLIA Waiver review, timelines, and deficiencies.
Coordinated Vulnerability Disclosure for Medical Device Cybersecurity
Practical guide to medical device CVD programs, including PSIRT setup, vulnerability intake, CVSS scoring, SBOM linkage, FDA Section 524B, EU expectations, and customer communication.