Industry News

Analysis of 5.08 million FDA GUDID records shows orthopedic devices lead at 49.6%, Cardinal Health and Medline hold 12.4% of a 10K-record sample, and Class II devices dominate at 85.3%.

Analysis of 58,374 FDA device recalls shows 85.8% are Class II, device design is the leading identified root cause at 13.0%, and annual recall volume peaked at 3,313 in 2017.

56,508 PMA records show cardiovascular dominates at 50.8%, top 5 applicants hold 31.5%, and the average PMA accumulates 34.5 supplements.

India's medical device market reached $20.98B in 2026 with 4,108 licensed manufacturers. Class A and B devices dominate at 76%, while imports supply 62% of market demand.

FDA's June 2026 draft guidance on reusing CMC, nonclinical, and clinical prior knowledge to accelerate gene therapy development, and its interaction with the Plausible Mechanism Framework.

Medical device M&A H1 2026: $26.6B Q1 deal value, 87% strategic buyers, Boston Scientific-Penumbra, Danaher-Masimo, portfolio reshaping trends, and H2 outlook for medtech dealmaking.

KIMES 2026 exhibitor analysis: 977 companies, 78% Korean, surgical devices lead at 259 exhibitors, 94% export-ready. China tops international pavilion with 81 companies.

Abbott Libre Duo CE mark analysis covering the first continuous glucose-ketone sensor, dual-analyte regulatory strategy, CGM competition, FDA pathway, and wearable convergence.

Quantum Surgical's 2026 NeuWave acquisition pairs Epione robotic ablation with microwave ablation technology under Precision IO Group for interventional oncology.

Analysis of Thermo Fisher's $1.1B microbiology divestiture to Astorg, including deal terms, Oxoid and Remel assets, $645M revenue, and diagnostics strategy.

Analyze the March 2026 Handala wiper attack on Stryker, its global manufacturing and order disruption, supply chain impact, and cybersecurity lessons for medtech.

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

Analysis of the FTC injunction blocking Edwards' JenaValve acquisition, the TAVR-AR innovation market theory, court ruling, and medtech M&A implications.

Analysis of Waters' $18.8B BD Biosciences combination, covering deal structure, analytical platforms, diagnostics synergies and impact on device and IVD manufacturers.

Analysis of Boston Scientific's up to $900M Bolt Medical acquisition, laser-based IVL technology, FDA 510(k) pathway, RESTORE and FRACTURE trials, Shockwave competition, and calcified artery market.

Analysis of J&J's DePuy Synthes separation and potential $20B+ sale, covering the 2025-2027 timeline, orthopedics revenue, VELYS robotics, buyer options, and medtech divestiture trends.

Stryker's $4.9B Inari Medical acquisition adds FlowTriever and ClotTriever platforms. Review deal structure, VTE thrombectomy competition, FDA pathways, and commercialization impact.

Analysis of DePuy Synthes' Gemtrack RF tracking deal, including VELYS strategy, competition with Mako and ROSA, J&J portfolio options, orthopedic robotics growth, and regulatory considerations.

Analysis of the IV-to-subcutaneous shift in biologics, covering on-body delivery systems, OBDS combination product pathways, human factors, and market drivers.

Analysis of Olympus's $270M BioProtect acquisition, including balloon spacer technology, prostate cancer radiation use, FDA 510(k) strategy, competitors, and commercialization impact.