Medical Device

Company Medical Device

Huadong Medicine’s Ellansé S Dermal Filler Receives NMPA Acceptance for Forehead Contouring Indication, Expanding China’s Premium Aesthetic Portfolio

Huadong Medicine Co., Ltd. (SHE: 000963) announced that the National Medical Products Administration (NMPA) has...

Company Medical Device

Shanghai Bio-heart Secures Israeli Registration for Iberis RDN System – World’s Only Dual-Access Renal Denervation Platform

Fineline Cube Jun 10, 2026

Shanghai Bio-heart Biological Technology Co., Ltd. (HKG: 2185) announced it has received regulatory approval for...

Company Medical Device

Sino Medical Sciences Secures Colombian Approval for HT Supreme Drug-Eluting Stent – Advanced Dual-Polymer Technology Expands Latin American Presence

Fineline Cube Jun 8, 2026

Sino Medical Sciences Technology Inc. (SHA: 688108) announced it has received marketing approval from Colombia’s...

Company Medical Device

GE HealthCare Secures FDA 510(k) Clearance for MIM Contour ProtégéAI+ 2.0 – AI Auto-Contouring Platform with Predetermined Change Control Plan

Fineline Cube Jun 5, 2026

GE HealthCare (NASDAQ: GEHC) announced it has received 510(k) clearance from the United States Food...

Company Deals Medical Device

Medtronic Makes Strategic ICE Catheter Investments to Strengthen Cardiac Ablation Leadership and Affera Ecosystem Integration

Fineline Cube Jun 4, 2026

Medtronic plc (NYSE: MDT) announced on June 3, 2026, strategic investments in two privately held...

Company Medical Device

Medtronic Submits FDA 510(k) Filings to Expand Hugo RAS System into General and Gynecologic Surgery, Adds LigaSure Maryland Instrument

Fineline Cube Jun 4, 2026

Medtronic plc (NYSE: MDT) announced on June 3, 2026, the submission of 510(k) premarket notifications...

Company Medical Device

Genesis MedTech Secures CE Mark for World’s First Integrated Scissor-Type Ultrasonic Scalpel, Following 2025 China Approval

Fineline Cube Jun 3, 2026

Genesis MedTech, a Singapore-based medical device innovator, announced it has received CE Mark certification for...

Company Medical Device

Basecare Medical Secures NMPA Category III Approval for Gems Oocyte Retrieval Solution in China’s IVF Market

Fineline Cube Jun 1, 2026

Basecare Medical Device Co., Ltd. (HKG: 2170), a specialist in high-throughput sequencing-based assisted reproduction technologies,...

Company Medical Device

Roche Launches Liver Disease Panel – Digital Algorithms Combine Biomarker Diagnostics with CE-Certified LiverPRO to Transform Chronic Liver Disease Management

Fineline Cube May 28, 2026

Roche Holding AG (SWX: ROP, OTCMKTS: RHHBY) announced the launch of its Liver Disease Panel,...

Company Medical Device

MicroPort NeuroTech Secures FDA Approval for NUMEN Helia Spring Coil System – Advanced Solution for Complex Neurovascular Lesions

Fineline Cube May 26, 2026

MicroPort NeuroTech Limited (HKG: 2172) announced it has received marketing approval from the U.S. Food...

Company Deals Medical Device

Lifetech Scientific to Acquire Starway Medical Technology in $276 Million Deal to Expand Structural Heart Portfolio

Fineline Cube May 25, 2026

Lifetech Scientific Corporation (HKG: 1302) announced plans to acquire a 96.46% stake in fellow Chinese...

Company Medical Device

Hangzhou Diagens Secures NMPA Category III Approval for AI AutoVision Chromosome Karyotyping System

Fineline Cube May 25, 2026

Hangzhou Diagens Biotechnology Co., Ltd. (HKG: 2526) announced it has received Category III medical device...

Company Medical Device

Jenscare’s LuX-Valve Plus Demonstrates 97.8% Efficacy in Tricuspid Regurgitation Reduction in Global EU TRINITY Study 12-Month Follow-Up

Fineline Cube May 21, 2026

Jenscare Scientific Co., Ltd (HKG: 9877), a structural heart disease device manufacturer, announced 12-month follow-up...

Company Medical Device

Sino Medical Sciences Secures EU Label Update for HT Supreme Stent, Enabling One-Month Dual Antiplatelet Therapy

Fineline Cube May 21, 2026

Sino Medical Sciences Technology Inc. (SHA: 688108) announced European Union regulatory approval for a label...

Company Medical Device

Shanghai ZJ Bio-Tech Secures International Approvals for Molecular Diagnostic Platforms in Netherlands and Mexico

Fineline Cube May 20, 2026

Shanghai ZJ Bio-Tech Co., Ltd. (SHA: 688317), a leading Chinese molecular diagnostic reagent specialist, announced...

Company Medical Device

Basecare Medical Device Secures NMPA Approval for Gems Embryo Culture Medium – Chinese IVF Specialist Completes Global Regulatory Triad

Fineline Cube May 14, 2026

Basecare Medical Device Co., Ltd. (HKG: 2170), a high-throughput sequencing-based assisted reproduction specialist, announced it...

Company Medical Device

Roche Secures CE Mark for Elecsys pTau217 Blood Test, First Single-Assay Alzheimer’s Diagnostic with Amyloid Pathology Detection

Fineline Cube May 13, 2026

Roche AG (SWX: ROP, OTCMKTS: RHHBY) announced on May 12, 2026, that it has received...

Medical Device

MicroPort CardioFlow Secures CE Mark for ENO Series Pacemakers with Advanced LBBAP Capability

Fineline Cube May 11, 2026

MicroPort CardioFlow Medtech Co., Ltd (HKG: 2160), a spin-off of MicroPort Scientific Corp (HKG: 0853),...

Company Medical Device

Suzhou Basecare Medical Secures China’s First NMPA Approval for Thalassemia Preimplantation Genetic Testing Kit

Fineline Cube Apr 30, 2026

Suzhou Basecare Medical Co., Ltd. (HKG: 2170) announced that China’s National Medical Products Administration (NMPA)...

Company Medical Device

Abbott Secures FDA Clearance and CE Mark for Ultreon 3.0 AI-Powered OCT Imaging Platform

Fineline Cube Apr 29, 2026

Abbott (NYSE: ABT) announced it has received U.S. Food and Drug Administration (FDA) clearance and...

Medical Device

Huadong Medicine’s Ellansé S Dermal Filler Receives NMPA Acceptance for Forehead Contouring Indication, Expanding China’s Premium Aesthetic Portfolio

Shanghai Bio-heart Secures Israeli Registration for Iberis RDN System – World’s Only Dual-Access Renal Denervation Platform

Sino Medical Sciences Secures Colombian Approval for HT Supreme Drug-Eluting Stent – Advanced Dual-Polymer Technology Expands Latin American Presence

GE HealthCare Secures FDA 510(k) Clearance for MIM Contour ProtégéAI+ 2.0 – AI Auto-Contouring Platform with Predetermined Change Control Plan

Medtronic Makes Strategic ICE Catheter Investments to Strengthen Cardiac Ablation Leadership and Affera Ecosystem Integration

Medtronic Submits FDA 510(k) Filings to Expand Hugo RAS System into General and Gynecologic Surgery, Adds LigaSure Maryland Instrument

Genesis MedTech Secures CE Mark for World’s First Integrated Scissor-Type Ultrasonic Scalpel, Following 2025 China Approval

Basecare Medical Secures NMPA Category III Approval for Gems Oocyte Retrieval Solution in China’s IVF Market

Roche Launches Liver Disease Panel – Digital Algorithms Combine Biomarker Diagnostics with CE-Certified LiverPRO to Transform Chronic Liver Disease Management

MicroPort NeuroTech Secures FDA Approval for NUMEN Helia Spring Coil System – Advanced Solution for Complex Neurovascular Lesions

Lifetech Scientific to Acquire Starway Medical Technology in $276 Million Deal to Expand Structural Heart Portfolio

Hangzhou Diagens Secures NMPA Category III Approval for AI AutoVision Chromosome Karyotyping System

Jenscare’s LuX-Valve Plus Demonstrates 97.8% Efficacy in Tricuspid Regurgitation Reduction in Global EU TRINITY Study 12-Month Follow-Up

Sino Medical Sciences Secures EU Label Update for HT Supreme Stent, Enabling One-Month Dual Antiplatelet Therapy

Shanghai ZJ Bio-Tech Secures International Approvals for Molecular Diagnostic Platforms in Netherlands and Mexico

Basecare Medical Device Secures NMPA Approval for Gems Embryo Culture Medium – Chinese IVF Specialist Completes Global Regulatory Triad

Roche Secures CE Mark for Elecsys pTau217 Blood Test, First Single-Assay Alzheimer’s Diagnostic with Amyloid Pathology Detection

MicroPort CardioFlow Secures CE Mark for ENO Series Pacemakers with Advanced LBBAP Capability

Suzhou Basecare Medical Secures China’s First NMPA Approval for Thalassemia Preimplantation Genetic Testing Kit

Abbott Secures FDA Clearance and CE Mark for Ultreon 3.0 AI-Powered OCT Imaging Platform

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Createrna’s MY008211A Becomes China’s First Home-Grown Oral CFB Inhibitor Approved for Paroxysmal Nocturnal Hemoglobinuria

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