Industry News
72 articles
Israel MOH Device Register: 28,800 Devices, 92% Imports, and Importer Concentration
Israel's MOH register lists 28,821 medical devices — 91.8% imported, the US/Germany/China supply 53.6%, and 2,111 importers (IRHs) hold the licence layer.
Japan PMDA Device Landscape: 88,900 Approved Products and MAH Concentration
Japan's PMDA database lists ~88,900 approved medical devices held by 2,796 MAHs; the top 50 MAHs hold 40.8%, and a 2021 cluster reflects the e-IFU/UDI mandate.
Vietnam MOH Device Register: 108,600 Valid Registrations and a 3× Decree 98 Surge
Vietnam's MOH register holds 108,658 valid registrations across 21,871 applicants; new filings tripled in 2022 under Decree 98. Highly fragmented (HHI 16).
Taiwan TFDA Registry: 52,726 Devices, Import Dependence, and Applicant Concentration
Analysis of Taiwan's TFDA medical device register shows 52,726 active devices. 74.1% are imported (US 22.6%, Germany 9.5%), Class II dominates at 52.9%, and top 10 applicants hold 14.5%.
UK MHRA Device Register: 22,554 Devices, UK Manufacturing Base & Post-Brexit Registration
Analysis of the UK MHRA device register shows 22,554 registered devices. UK manufacturers hold 33.5%, IVD accounts for 37.7%, and the top 10 manufacturers hold 13.1% of registrations.
FDA Class I Device Recalls: 3,510 Events, Firms, and Trends Since 2006
3,510 FDA Class I device recalls since 2006, led by Medtronic, Boston Scientific and Teleflex. Catheters and ventilation devices drive a sharp post-2020 rise.
FDA MAUDE Trends 2020–2025: 14.4M Reports, Diabetes Dominance, Rising Deaths
Analysis of 14.4M FDA MAUDE adverse event reports (2020–2025) shows diabetes devices account for over half of all events. Death reports rose 63% from 2020 to 2024.
Singapore HSA Registry: 20,600 Devices, Ownership, and Registrant Concentration
Analysis of Singapore's medical device register shows 20,599 approved devices across 859 registrants. Top 20 registrants hold 35.5%, while US product owners hold 37.9% of all devices.
Who Clears the Most FDA 510(k) Devices? 175K Records by Country and Applicant
Analysis of 175,149 FDA 510(k) clearances shows foreign applicants exceed US ones since 2021. China leads non-US at 19.1%, top 50 applicants hold under 10%.
Global Device Manufacturing Map: 24,795 FDA-Registered Establishments
FDA establishment data shows 59.7% of 24,795 registered facilities are foreign. China leads with 4,753 establishments and contract manufacturing dominates.
UDI Database Decoded: 5.08M Records Show Orthopedic Dominance, Concentration
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%.
FDA Medical Device Recalls Decoded: 58K Records, Root Causes, and Trends
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.
PMA Class III Landscape: 56,508 Records Show Cardiovascular Dominance
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 Decoded: 4,108 Manufacturers, 62% Imports
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 Prior Knowledge Framework for Cell and Gene Therapy: Draft Guidance June 2026
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.
MedTech M&A Market Analysis H1 2026: Deal Trends, Strategic Shifts, and Outlook
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: 977 Exhibitors, 78% Korean, Surgical Leads — Korea Export Push
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: Dual Glucose-Ketone CGM Strategy (2026)
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 Acquires NeuWave Medical: Precision IO and Robotic Ablation
Quantum Surgical's 2026 NeuWave acquisition pairs Epione robotic ablation with microwave ablation technology under Precision IO Group for interventional oncology.
Thermo Fisher Microbiology Divestiture to Astorg: $1.1B Deal Analysis
Analysis of Thermo Fisher's $1.1B microbiology divestiture to Astorg, including deal terms, Oxoid and Remel assets, $645M revenue, and diagnostics strategy.