Digital Health & AI
87 articles
Health Canada MLMD Guidance 2026: PCCP, Bias, and AI Lifecycle
Guide to Health Canada's 2026 MLMD guidance for AI/ML devices, including PCCPs, data quality, bias controls, lifecycle risk, digital submissions, and FDA/EU comparisons.
Medical Device AI Bias Testing: Fairness Validation and Documentation
How to test AI-enabled medical devices for demographic bias, validate fairness statistically, document FDA and EU submissions, and monitor post-market performance.
SaMD Clinical Evaluation: Clinical Evidence for FDA and EU MDR Submissions
Guide to SaMD clinical evaluation, covering valid clinical association, analytical validation, clinical performance, FDA expectations, EU MDR evidence, and real-world data.
Medtronic CathWorks and Scientia Deals: Cardiovascular and Neurovascular
Review Medtronic's 2026 CathWorks and Scientia Vascular deals, covering FFRangio coronary diagnostics, neurovascular access technology, deal value, and tuck-in M&A strategy.
Roche-PathAI Acquisition: AI Digital Pathology and Companion Diagnostics
Analysis of Roche's PathAI acquisition, including AI pathology technology, companion diagnostic strategy, SaMD and IVD regulatory issues, and precision oncology impact.
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.
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.
EU Breakthrough Device (BtX) Designation: MDCG 2025-9 and EMA Pilot Guide
Guide to the EU BtX framework under MDCG 2025-9, covering eligibility, application steps, EMA pilot benefits, FDA comparisons, and IVD implications.
MedTech Europe MDR/IVDR 2.0 Position Paper: Proposed Changes
Analyze MedTech Europe's May 2026 MDR/IVDR position paper, including breakthrough and orphan pathways, cybersecurity, AI, IVDR concerns, and the legislative process.
EU AI Act Omnibus Amendment 2026: Medical Device Impact Guide
Explains the May 7, 2026 EU AI Act omnibus deal, product safety exemptions, revised timelines, and compliance actions for AI-enabled SaMD and IVDs.
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.
EU AI Act and MDR Single Evidence Matrix for AI Medical Devices
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.
FDA AI-Enabled Device Predicate Mining for 510(k) and De Novo
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.
FDA Cybersecurity Unresolved Anomalies Table for Premarket Submissions
Guide to building an FDA unresolved software anomalies table for cybersecurity submissions, including CVSS, exploitability, clinical impact, controls, SBOM links, VEX status, and labeling.
IEC 62304 Edition 2: 2026 Software Lifecycle Changes for Devices
Prepare for IEC 62304 Edition 2 with process rigor levels, broader health software scope, AI/ML lifecycle provisions, cybersecurity integration, and compliance timelines.
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.
PCCP Drift Monitoring for AI Imaging Devices: Thresholds and Retraining Triggers
Build FDA PCCP drift monitoring protocols for AI imaging devices, including dataset shift, scanner drift, thresholds, cadence, retraining triggers, and submission boundaries.
SBOM-to-VEX Vulnerability Triage Workflow for Medical Device PSIRTs
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.
Special 510(k) for Software and Cybersecurity Changes: Decision Tree and Evidence Package
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.