Industry News

W.L. Gore completed its acquisition of Conformal Medical in February 2026, adding the investigational CLAAS AcuForm left atrial appendage occlusion system to its cardiovascular portfolio. Covers foam-based LAAO technology designed to conform to variable anatomies, the $1.2B LAAO device market dominated by Boston Scientific's Watchman and Abbott's Amulet, the CONFORM pivotal trial, and how a rare strategic acquisition by the privately held materials science giant reshapes competitive dynamics in structural heart.

CareDx agreed to acquire Naveris for up to $260M on April 28, 2026, marking its strategic expansion from transplant diagnostics into HPV-driven cancer surveillance. Covers NavDx liquid biopsy technology, TTMV DNA biomarker science, deal structure ($160M upfront + $100M milestones), CareDx's divestiture of Lab Products, and the $4.5B molecular residual disease monitoring market.

Johnson & Johnson entered a definitive agreement to acquire Atraverse Medical on April 24, 2026, adding the FDA-cleared HOTWIRE Transseptal Access System to its cardiac ablation portfolio. Covers RF-guidewire technology for left-heart access, the Atraverse founding team behind Farapulse (Boston Scientific), J&J's electrophysiology strategy including Shockwave and Varipulse, and the competitive landscape in the $10B+ cardiac rhythm management market.

Stryker completed its acquisition of Amplitude Vascular Systems on May 7, 2026, adding next-generation intravascular lithotripsy (IVL) technology to its peripheral vascular portfolio. Covers the CO2-generated pressure wave platform, why IVL matters for calcified PAD treatment, competitive dynamics with J&J/Shockwave, regulatory pathway, and implications for the $4B+ peripheral vascular device market.

In-depth analysis of Bayer's acquisition of Perfuse Therapeutics for up to $2.45 billion, marking its return to M&A after a 5-year drought. Covers the PER-001 intravitreal implant for glaucoma and diabetic retinopathy, deal structure, endothelin receptor antagonism mechanism, the growing drug-device combination product market, and what it means for ophthalmic medtech manufacturers and investors.

GE HealthCare announced a sweeping restructuring of its business segments and executive leadership team alongside Q1 2026 earnings that missed expectations. Facing $250M in inflationary cost increases driven by memory chips, oil, and freight, the company is raising prices and cutting its profit outlook. Covers the new Advanced Imaging Solutions segment, leadership changes, the inflation impact on medtech supply chains, and what device manufacturers should expect.

Sun Pharmaceutical Industries agreed to acquire Organon & Co. for $11.75 billion in the largest pharmaceutical deal of 2026 and India's largest overseas pharma acquisition. Covers deal structure, Organon's portfolio of women's health products (Nexplanon, NuvaRing) and biosimilars (Hadlima, Renflexis), the drug-device combination products involved, regulatory considerations for combination products, and what the deal means for the women's health and biosimilar device landscape.

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.

How the EPA's 2026 proposed rollback of ethylene oxide emissions standards affects medical device manufacturers, sterilization facilities, and supply chains — the 2024 rule, proposed changes, compliance timelines, and alternative sterilization strategies.

A comprehensive guide to MDUFA VI — the 2027-2032 FDA medical device user fee agreement covering CDRH staffing restoration, America-First fee restructuring, real-world evidence provisions, fee projections, and practical preparation strategies for device manufacturers.

The medical device CDMO market is projected to grow from $134.65 billion in 2025 to $354.60 billion by 2033 at 13.12% CAGR. This guide covers market size, growth drivers, key players (Jabil, Integer, Flex, Plexus), M&A trends, and how to choose the right contract manufacturing partner.

How FDA and CDRH staffing cuts are affecting 510(k) review times, pre-submission meetings, and regulatory strategy — with data on CDRH capacity, MDUFA V performance, and practical mitigation strategies for device companies.

An analysis of the EU MDR and IVDR Notified Body capacity crisis using 2026 survey data — 33,175 MDR applications vs 17,549 certificates issued, 13–18 month review times, IVDR Class C deadline, and a practical action plan for manufacturers facing certification gaps.

A comprehensive guide to regulatory sandboxes for medical devices — MHRA AI Airlock (£3.6M expansion), FDA TEMPO pilot for digital health, EU sandbox proposals, and how manufacturers can participate in these programs to accelerate market access.

Comprehensive guide to every major medical device trade show and conference in 2026 — including MEDICA, MD&M West, AdvaMed, RAPS Regulatory Convergence, DeviceTalks, and 50+ events worldwide with dates, locations, and what each event delivers.

Complete career guide for medical device regulatory affairs professionals — career paths from entry level to VP, salary ranges by role and region, RAC certification details, essential skills, and how to break into the field in 2026.

A comprehensive guide to Health Technology Assessment (HTA) for medical devices — EU HTA Regulation 2026, NICE evaluations, Joint Clinical Assessments, economic modeling, evidence requirements, and strategies for securing reimbursement and market access globally.

Original data analysis of 111,000+ ANVISA medical device registrations reveals market trends, fastest-growing registration holders, product category shifts, and optimal market entry strategies for Brazil.

How US tariffs, EU-China trade tensions, and Mexico's new tariff law are reshaping global medtech supply chains in 2026 — with real financial impacts from J&J, Intuitive Surgical, Boston Scientific, and practical strategies for manufacturers.

Comprehensive analysis of the Middle East & North Africa medical device market — $24.6B in 2025 growing to $35B by 2032 at 5.1% CAGR. Saudi Arabia's $35.5B Global Health Exhibition deals, 400 GCC healthcare transactions (2021–2025), UAE $3.18B market, Egypt $4.37B, digital health at 19.6% CAGR, and smart devices growing at 10.16% CAGR.