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

New York State Clears Innovative Liquid Biopsy Test To Diagnose Infectious Diseases

Executive Summary

The New York State Department of Health Clinical Laboratory Evaluation Program (CLEP) has cleared an innovative test from life sciences company Karius that can detect more than 1,000 pathogens from all five classes. 

You may also be interested in...



CDRH 2022: Shuren Says COVID-19 Left Agency ‘Battle-Scarred’ But Also Wiser

The US Food and Drug Administration’s device center released its annual report, noting the challenges posed by monkeypox on top of the ongoing COVID-19 pandemic. The report also cites what the center sees as its accomplishments for the year.

Philips Implements Plan To Address FDA Concerns Following Harsh Inspection Report

After a lengthy inspection of a Philips facility that manufactured several recalled breathing and ventilator devices, the US Food and Drug Administration delivered a pointed report to the company highlighting multiple risk management and quality systems issues. In response, Philips wrote to the FDA outlining steps it plans to take to fix the problems.

News We're Watching – 27 January

This feature compiles news briefs on a range of US regulatory and legal happenings. This week: Medtronic seeks HeartWare batteries; companies sign health equity pledge; insulin dosing app cleared; recall on field decontamination kits; and the renewal of an FDA panel. 

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT144377

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