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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.

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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.

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