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Tag: Medical Device Labeling

FDA Grants Breakthrough Device Designation for EndoStim’s GERD Treatment

EndoStim announced on October 25th that the FDA granted a breakthrough device designation for the company’s implantable neurostimulation treatment for drug refractory gastroesophageal reflux disease...

HSA Guidance on Change of Registrant: Overview

The article describes the regulatory procedures to be followed when changing a registrant of a medical device.  Table of Contents The...

FDA Guidance on Ethical Considerations for Clinical Investigations: Overview

The article provides an overview of the applicable regulatory requirements for ethical considerations in the context of clinical investigations of medical devices initially intended...

Sensus Healthcare to Host Third Quarter 2022 Financial Results and Business Update Conference Call on November 3, 2022

BOCA RATON, Fla., Oct. 27, 2022 (GLOBE NEWSWIRE) -- Sensus Healthcare, Inc. (Nasdaq: SRTS), a medical device company specializing in highly effective, non-invasive treatments...

Radiaction Medical Announces the Latest Food and Drug Administration 510(k) Clearance for its Novel, Automated Radiation Shield System, Highlighting U.S. Expansion

TEL AVIV, Israel--(BUSINESS WIRE)-- Radiaction Medical, Ltd. (“Radiaction”), a medical device innovator dedicated to providing healthcare physicians and staff with effective radiation protection during...

Registration Certificates Become Paperless

The electronic registration certificate for medical devices will be fully implemented, from November 1, 2022. After October 2020, when the electronic certificates for domestic class...

Current Data Support Early Detection and Intervention to Reduce Rates of Breast Cancer-Related Lymphedema

L-Dex Found to be a Cost Effective, Reproducible, and Practical Method to Monitor Breast Cancer Patients for Early Signs of Lymphedema CARLSBAD, Calif., Oct. 26,...

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