Industry News

Analysis of Bayer's up to $2.45B Perfuse Therapeutics acquisition, including the PER-001 intravitreal implant, deal terms, endothelin mechanism, and ophthalmic drug-device convergence.

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

Sun Pharma's $11.75B Organon deal reshapes women's health and biosimilars. Review deal structure, combination-product considerations, portfolio assets, and regulatory impact.

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 EPA's 2026 proposed EtO emissions rollback for medical device sterilization, covering the 2024 rule, compliance timelines, supply chain risk, and alternatives.

Guide to MDUFA VI for 2027-2032, covering FDA device user fee changes, CDRH staffing, real-world evidence provisions, fee projections, and preparation steps.

Analysis of the 2026 medical device CDMO market, including growth forecasts, major players, M&A trends, outsourcing drivers, and partner selection criteria.

How FDA and CDRH staffing reductions may affect 510(k) reviews, pre-submission meetings, MDUFA goals, and regulatory planning for device companies.

Analysis of EU MDR and IVDR Notified Body capacity using 2026 survey data, review timelines, certification bottlenecks, IVDR Class C risk, and manufacturer actions.

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

Plan 2026 medical device trade show attendance with dates, locations, and event focus for MEDICA, MD&M West, AdvaMed, RAPS, DeviceTalks, and other global conferences.

Career guide for medical device regulatory affairs, covering role progression, salary ranges, RAC certification, core skills, and entry strategies for 2026.

Guide to HTA for medical devices, covering EU HTA Regulation 2026, NICE, Joint Clinical Assessments, economic evidence, reimbursement, and market access strategy.

Original analysis of 111,000+ ANVISA medical device registrations, showing Brazil market trends, leading registration holders, category shifts, and market entry strategy.

Understand how 2026 tariffs, EU-China trade tension, and Mexico tariff changes affect medtech supply chains, with manufacturer impacts and practical mitigation strategies.

Analyze the 2026 MENA medical device market, including regional size, Saudi investment, GCC transactions, UAE and Egypt growth, digital health trends, and smart device demand.

Tracker of major medtech M&A deals in 2025 and 2026, including Abbott-Exact Sciences and Boston Scientific-Penumbra, with deal values, strategic rationale, and industry trends.

Analysis of 2025-2026 medtech divestitures and spinoffs, including BD-Waters, J&J DePuy Synthes, Siemens Healthineers, Medtronic MiniMed, and why large players are breaking up.

Review the 2026 medtech IPO and SPAC outlook, including Medline, Medtronic MiniMed, digital health listings, SPAC activity, public market conditions, and the pipeline.

2026 ranking of the largest medical device companies by revenue, with market share context, strategic shifts, and growth drivers across global medtech.