Zephyrnet Logo

Medical Devices

Two Review Reports for Imported Devices Issued in January

NMPA published twelve review reports in January 2024 for innovation devices. Among them are two imported devices. These published review reports serve as important references...

MDCG Guidance on Clinical Investigations: Content and Modifications | EU

The new article provides additional clarifications concerning the content of submissions associated with clinical investigations and modifications to it. Table of...

Serbian Guidance on Amendments to MD Registration: Overview | Serbia

The article highlights the key points associated with factors to be considered when determining the eligibility of a medical device type for a third-party...

Medical Device Companies Annual Self-Inspection Report Due March 31

All domestic and overseas manufacturers with approved medical devices shall conduct the annual self-inspection of the quality management system, according to Decree 719 “Medical...

NMPA Review Report Released for Israeli Osteosynthesis Plate System

The NMPA granted innovation approvals to Israeli company CarboFix Orthopedics’ carbon fiber polyetheretherketone (PEEK) osteosynthesis plate system and issued a review report. These published review...

FDA Grants Humanitarian Device Exemption Approval to SeaStar Medical’s Selective Cytopheretic Device for Pediatric Acute Kidney Injury | BioSpace

SCD-PED (Pediatric) is the first FDA-approved product in the Company’s Quelimmune™ product family DENVER, Feb. 22, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq:...

EVŌQ Nano Announces That Its Antimicrobial Medical Device Platform Demonstrates Success Against the Leading Cause of Healthcare-Associated Infections | BioSpace

Novel Nanoparticle Platform Shows Efficacy Against Antimicrobial Resistance; Potential to Disrupt the $29 Billion Catheter Market SALT LAKE CITY, Feb. 22, 2024 /PRNewswire/ --...

Latest Intelligence

spot_img
spot_img