Digital Health & AI

What GE HealthCare's 2026 restructuring, leadership changes, price increases, and $250M inflation hit mean for medtech supply chains and device manufacturers.

Analysis of Danaher's $9.9B Masimo acquisition, including deal structure, strategic rationale, antitrust considerations, patient monitoring competition, and medtech industry impact.

Guide to the EU BtX framework under MDCG 2025-9, covering eligibility, application steps, EMA pilot benefits, FDA comparisons, and IVD implications.

Analyze MedTech Europe's May 2026 MDR/IVDR position paper, including breakthrough and orphan pathways, cybersecurity, AI, IVDR concerns, and the legislative process.

Explains the May 7, 2026 EU AI Act omnibus deal, product safety exemptions, revised timelines, and compliance actions for AI-enabled SaMD and IVDs.

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.

What device sponsors need to know about FDA's 2026 real-time clinical trials pilot, AI-enabled monitoring, Paradigm Health, and participation readiness.

Guide to building one evidence matrix for AI medical devices under EU MDR and the EU AI Act, mapping Annex II/III files, ISO 14971 risks, PMS/PMCF, cybersecurity, data governance, and QMS evidence.

Method for mining FDA AI-enabled device and 510(k) databases to identify predicates, compare technology, avoid weak arguments, and build a defensible predicate matrix.

Guide to building an FDA unresolved software anomalies table for cybersecurity submissions, including CVSS, exploitability, clinical impact, controls, SBOM links, VEX status, and labeling.

Prepare for IEC 62304 Edition 2 with process rigor levels, broader health software scope, AI/ML lifecycle provisions, cybersecurity integration, and compliance timelines.

Document NGS bioinformatics pipeline changes, assess validation impact, control software and database updates, and prepare IEC 62304 audit records for IVDs.

Build FDA PCCP drift monitoring protocols for AI imaging devices, including dataset shift, scanner drift, thresholds, cadence, retraining triggers, and submission boundaries.

PSIRT playbook for medical device SBOM-to-VEX triage, covering CVE intake, component matching, exploitability analysis, VEX rationale, severity scoring, CAPA, field action, and communications.

Decision tree for when a software or cybersecurity update can use Special 510(k) vs Traditional 510(k) — risk analysis, V&V summary, FDA guidance, and evidence package requirements.

Guide to 12 common FDA cybersecurity premarket deficiencies in 2026, including SBOM, threat modeling, risk assessment, Section 524B, guidance alignment, and practical fixes.

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.

Guide to medical device regulatory sandboxes, including MHRA AI Airlock, FDA TEMPO for digital health, EU proposals, eligibility, participation, and market access benefits.

Independent comparison of regulatory intelligence software for medical device and IVD teams, covering RegDesk, IQVIA, Cortellis, Obsidian, Basil Systems, ArisGlobal, Freyr, and Veeva.

Practical guide to digital twins, synthetic data, and computational modeling in medical device submissions, covering FDA credibility guidance, ASME V&V 40, validation limits, and documentation.