Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


Breast Tumor Ablation Study Parameters To Be Reviewed By FDA Panel

This article was originally published in The Gray Sheet

Executive Summary

Clinical trial criteria for studying percutaneous breast tumor removal devices will be explored by FDA's General & Plastic Surgery Devices Panel during a July 24 meeting in Gaithersburg, Md

You may also be interested in...

Hemostatic Agent Downclassification Should Await Guidance – Panel

FDA plans to develop a draft guidance document for absorbable hemostatic agent 510(k) submissions and submit it for panel review before reconsidering downclassification of the devices

Endocare Gains Clearance For Benign Breast Tumor Therapy; Malignant Next

Endocare will follow up its FDA 510(k) clearance of the Visica minimally invasive cryoablation system for benign breast tumors with a submission for malignant tumors.

Dr Reddy’s Wants To Break Into Top Five In India

Dr Reddy’s signals a sharp step up in ambitions at home, propelled by building leadership in 10 therapy segments and an “India-first” approach for specialty products. Uptick in the China business and the potential launch of a Russia-partnered COVID-19 vaccine were other aspects of the business discussed at JPM.




Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts