In Vivo 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


Picture archiving and communications systems

This article was originally published in The Gray Sheet

Executive Summary

July 27 FDA guidance on 510(k) submissions for the Class II devices is not applicable to either medical information systems for non-clinical data, or "image processing devices that utilize artificial intelligence or other techniques to identify abnormalities in medical images or assist in diagnosis," the document states

You may also be interested in...

Regulatory News In Brief

Opened but unused SUDs: Comments on hospital practices associated with opened but unused single use devices (SUDs) are due by Nov. 26. Specific questions posed in the 1Aug. 28 notice on opened but unused SUDs include: what SUDs are typically resterilized because they are open but unused; how hospitals decide when an opened but unused SUD is contaminated; and whether hospitals have standard operating procedures for such determinations. The agency says it is seeking the information as part of a review of its policy on opened but unused SUDs, which are defined as single-use disposable devices that have not been used on a patient but whose sterility is in question. FDA is seeking comments from hospitals, original equipment manufacturers, reprocessors, professional organizations and other interested parties...

Keeping Track: US FDA Clears Esperion’s Nexletol, Baudax’ Anjeso, Agile’s Twirla

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.




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