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Meridian Bioscience Inc.

https://www.meridianbioscience.com/

Latest From Meridian Bioscience Inc.

MDR/IVDR Survey: Most Manufacturers Ready To Yank Some Legacy Products From EU Market; Hiring Up At Firms

The impending implementation of the EU's new Medical Device and IVD Regulations will cause most firms to pull select legacy devices and in vitro diagnostics from the EU market, a survey of 169 quality and/or regulatory professionals finds. The survey also revealed that companies are in hiring mode as the compliance dates for both regulations approach. Quality and regulatory officials from Abbott Laboratories and Meridian Bioscience weigh in.

Policy Regulation

Magellen Gets Warning Letter On Lead Test Concerns

The warning letter alleges the company sold modified versions of its blood lead tests without alerting US FDA, and didn’t tell the agency about reported discrepancies in test results. FDA first warned of possible faulty test results in May.

Compliance Quality Control

US FDA, CDC Warn Of False Results On Lead Blood Tests

Common blood tests for lead poisoning manufactured by Magellan Diagnostics could give false low results if used with venous blood, FDA warned. About 8 million of the tests have been performed since 2014.

In Vitro Diagnostics Safety

Device/Diagnostics Quarterly Deal Statistics, Q1 2016

Device companies raised 50% more in Q1 2016 than the previous quarter, reaching $1.8 billion and led by debt offerings; diagnostic imaging acquisitions, such as Toshiba Medical Systems, were abundant. Diagnostics financings double in Q1, mostly from venture funding, including strong showing from liquid biopsy companies.

Medical Device Market Intelligence
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Company Information

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