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

News Briefs: Dx Bill Reintroduced; FDA Questions Guided Therapeutics’ LuViva; Study Milestones

This article was originally published in The Gray Sheet

Executive Summary

Rep. Leonard Lance reintroduced a bill in the House to address flaws in Medicare’s reimbursement system for diagnostics. Guided Therapeutics receives more questions from FDA on the PMA for its LuViva cervical scan. Study news from InSightec, Direct Flow Medical and PLC Systems. More news.

You may also be interested in...



Business Briefs

Insulin device firm CeQur and liquid biopsy firm Exosome Diagnostics closed financing rounds; Abbott completes its transcatheter mitral valve replacement deal; Unilife considers its options; and Quest Diagnostics subsidiary advances infectious disease offerings.

Reimbursement Briefs: TAVR Trial; Competitive Bidding Suppliers; OIG, GAO Reports

CMS approves coverage for Direct Flow TAVR study and announces durable medical equipment competitive bidding suppliers; OIG uncovers inappropriate payments for durable medical equipment. More reimbursement news.

Addressing The Device Backlog: Government Shutdown Ends, Now FDA Has To Catch Up

After the shutdown, FDA staff are facing a backlog of fiscal year 2014 device submissions. The agency is working on a plan and assessing its ability to meet its MDUFA III commitments. The bigger concern, however, may be the regulatory uncertainty created by the short-term deal in Congress.

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

MT032412

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