Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

FDA: Transducer Test A Key Element In Ultrasound Guidance

Executive Summary

The US agency lifted 510(k) requirements for many diagnostic ultrasounds via a June guidance document. But a new focus on transducer element safety is still posing some challenges, FDA staff said during a recent webinar on the policy changes.

You may also be interested in...



No More 510(k)s For Certain Ultrasound Diagnostic-Makers

Ultrasound diagnostic devices that already have a 510(k) won't have to be resubmitted for clearance following modifications if they meet all 10 requirements set forth in an updated US FDA guidance.

It’s A Class I Recall For Baxter’s WatchCare Device

Radiofrequencies from the incontinence-sensing devices may interfere with other medical equipment in a hospital setting. 

Ex-Theranos CEO Elizabeth Holmes Sentenced To 11-Year Prison Term

The former diagnostics company executive was convicted in January on four counts of fraud.

Topics

Latest News
See All
UsernamePublicRestriction

Register

MT125559

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

Cancel