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

UsernamePublicRestriction
UsernamePublicRestriction

ASTM Evaluating Two MR Safety/Compatibility Standards, Approves One

This article was originally published in The Gray Sheet

Executive Summary

The American Society for Testing and Materials' "Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants" could be approved in final form as early as September, FDA officials say.

You may also be interested in...



MEDICAL DEVICE LABELING ON MR COMPATIBILITY SHOULD CITE SPECIFIC TESTING ENVIRONMENT, FDA SAYS IN "PRIMER"; JUSTIFYING DATA FOR CLAIMS OUTLINED

Medical devices should not be labeled as magnetic resonance "compatible" or "safe," FDA says in a draft "primer" on medical device interactions with MR imaging systems. Rather, labeling should describe the specific MR environment in which the device has been tested and deemed safe, the agency recommends in the draft document, which was recently released for comment.

Bristol/Exelixis Detail Survival Benefit For Opdivo/Cabometyx In Renal Cancer

Data show Opdivo/Cabometyx combo bests Sutent for overall and progression-free survival and response endpoints in first-line RCC. Exelixis CEO says comparison to Sutent is standard control and allows better comparison to other combo regimens.

Finance Watch: 2020 IPOs Surpass 2019 Total With 52 To Date

ES: Public Company Edition: Fifty biopharma companies launched initial public offerings in the US last year and there have been 52 so far in 2020, including Metacrine, Dyne, Athira and COMPASS.

UsernamePublicRestriction

Register

MT101489

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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

Cancel