Digital Health & AI

Regulatory guide to liquid biopsy and MCED tests, including FDA pathways, Breakthrough designation, companion diagnostics, EU IVDR classification, clinical evidence, and key market players.

Prepare for mandatory REP and CESG submissions for Class II-IV medical device licences, including IMDRF ToC format, XML templates, workflow changes, and April 2026 scope.

Guide to FDA's TEMPO pilot for digital health devices, enforcement discretion, real-world evidence, CMS ACCESS alignment, eligibility, and key dates.

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.

Oura's confidential 2026 IPO filing, $11B valuation, wearable health platform strategy, and what its public-market move signals for medtech.

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

How medical device companies can join FDA's 2026 READI-Home challenge, including eligibility, phases, Q-submissions, and early engagement benefits.

Prepare for CIRCIA cyber incident reporting rules, including 72-hour CISA reports, 24-hour ransomware payment notices, FDA overlap, coverage, and readiness steps.

Review FDA's 2026 weight loss device guidance, including clinical study design, benefit-risk analysis, nonclinical testing, and obesity device strategy.

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.

How to test AI-enabled medical devices for demographic bias, validate fairness statistically, document FDA and EU submissions, and monitor post-market performance.

Guide to SaMD clinical evaluation, covering valid clinical association, analytical validation, clinical performance, FDA expectations, EU MDR evidence, and real-world data.

Review Medtronic's 2026 CathWorks and Scientia Vascular deals, covering FFRangio coronary diagnostics, neurovascular access technology, deal value, and tuck-in M&A strategy.

Analysis of Roche's PathAI acquisition, including AI pathology technology, companion diagnostic strategy, SaMD and IVD regulatory issues, and precision oncology impact.

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.