IVD & Diagnostics

In-depth analysis of Danaher's $9.9 billion acquisition of Masimo, the largest medtech deal of 2026. Covers deal structure, strategic rationale, regulatory and antitrust considerations, competitive landscape impact on patient monitoring, and what it means for device manufacturers, hospitals, and investors.

A practical survival guide for IVD manufacturers facing the May 26, 2026 IVDR Class C transition deadline. Covers who must apply to a Notified Body, the September 2026 agreement deadline, conditions for extended market access through 2028, common pitfalls, and a step-by-step action plan.

Operational guide to the invalid-result workflow for home-use and self-test IVDs — covering invalid rate targets, lay-user error coding, repeat-test instructions, IFU comprehension, customer support scripts, specimen collection errors, adverse event handling, and postmarket trending.

Practical guide to change control for NGS bioinformatics pipelines in IVD devices — covering variant caller updates, reference database changes, threshold modifications, wet-lab/software interface validation, IEC 62304 documentation, revalidation triggers, and postmarket records.

Operational guide to converting an RUO-labeled assay or reagent into a cleared or approved IVD — covering marketing claims cleanup, distributor scripts, customer notices, historical data triage, validation bridge strategy, complaint transition, sales training, and evidence firewall construction.

Dedicated CLIA waiver playbook for IVD manufacturers — covering waived, moderate, and high complexity categories, CW submission content, flex studies, lay-user studies, the Dual 510(k) + CLIA Waiver pathway, review timelines, common deficiencies, and real-world examples.

Regulatory, commercial, and privacy risk guide for direct-to-consumer (DTC) genetic testing companies — covering FDA oversight of DTC IVDs, wellness vs. medical claims boundaries, analytical and clinical validity requirements, risk report authorization, GINA and state privacy laws, FTC advertising substantiation, 23andMe bankruptcy data precedent, and practical guidance on claims that change regulatory status.

Practical regulatory guide for home-use and self-test in vitro diagnostic devices — covering FDA pathways (OTC, prescription home use, CLIA waiver), EU IVDR self-testing requirements, human factors and lay-user usability, specimen collection errors, labeling requirements, DTC vs provider-ordered models, and post-market surveillance for consumer diagnostics.

Protocol-level analytical validation guide for IVD manufacturers — covering test plan tables, acceptance criteria, sample selection, statistical methods per CLSI standards, and FDA/EU IVDR expectations for analytical performance evidence.

Comprehensive regulatory and validation strategy for next-generation sequencing (NGS) in vitro diagnostic devices — covering FDA pathways (510(k), De Novo, PMA), proposed CDx reclassification, EU IVDR classification, wet lab and bioinformatics pipeline validation, variant calling, reference databases, clinical validity, cybersecurity, and post-market obligations.

Practical labeling and intended-use boundary guide for IVD manufacturers — covering FDA RUO/IUO guidance, clinical diagnostic use triggers, enforcement actions, marketing language risk, distributor behavior, and a decision tree for regulatory classification.

Complete guide to laboratory developed test regulation in 2026 — FDA's vacated 2024 final rule, the ACLA court decision, current CLIA oversight, enforcement discretion status, and what laboratories must do now.

Complete guide to in vitro diagnostic (IVD) registration across MENA — Saudi SFDA IVD classification (A–D) and companion diagnostic guidance, UAE EDE IVD requirements and fees, Egypt EDA IVD classes with ISO 15189/CLSI performance evaluation, Turkey TITCK IVDR-aligned framework, Israel AMAR IVD declaration route, and point-of-care testing requirements.

A practical walkthrough of all 7 IVDR classification rules in Annex VIII — with real device examples, software classification guidance, the IVDD-to-IVDR shift, and the 2025 EU simplification proposal that may reclassify certain IVDs.

Complete guide to companion diagnostic device regulation — FDA CDx approval pathways, EU IVDR requirements, co-development with therapeutics, PMA/De Novo strategies, and real-world case studies from oncology to rare diseases.

Comprehensive guide to point-of-care testing regulation — CLIA waiver requirements, FDA review pathways for POCT devices, EU IVDR classification, quality management, and the rapidly growing near-patient testing market.

Everything you need to know about IVD device regulations — FDA classification, EU IVDR classes A-D, performance evaluation, companion diagnostics, LDTs, and global regulatory requirements.

How to conduct performance evaluation under the EU IVDR — scientific validity, analytical performance, clinical performance, classification rules, and what Notified Bodies expect.