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Meridian Bioscience Inc.

Magellan widens lead test recall

June 7, 2017 By Sarah Faulkner

The FDA this week expanded its Class I recall of lead poisoning tests from Magellan Diagnostics to include 2 additional testing systems. The regulatory watchdog said it recalled Magellan’s LeadCare testing systems because they may underestimate blood lead levels and provide inaccurate results with venous blood samples. Get the full story at our sister site, Drug […]

Filed Under: Diagnostics, Food & Drug Administration (FDA), Recalls Tagged With: magellandiagnostics, Meridian Bioscience Inc.

pSivida, Alimera want FDA to give eye treatment another look | Regulatory roundup

May 13, 2011 By MassDevice staff Leave a Comment

Clearances roundup

pSivida Corp. (NSDQ:PSDV) and Alimera Sciences Inc. (NSDQ:ALIM) are having another go at gaining approval from the FDA for a drug/device combination to treat diabetic macular degeneration.

Filed Under: 510(k), Food & Drug Administration (FDA), News Well Tagged With: Abbott, Alimera Sciences, Avinger, Bioness Inc., iCad Inc., Insys Therapeutics Inc., Meridian Bioscience Inc., pSivida Corp.

Intel and GE win FDA clearance for virtual care platform | Regulatory roundup

March 3, 2011 By MassDevice staff Leave a Comment

Clearances roundup

Intel Corp. (NSDQ:INTC) and General Electric Co. (NYSE:GE) joint venture Intel-GE Care Innovations LLC won 510(k) clearance from the Food & Drug Administration for a virtual care coordination platform.

The clearance for the news system, called Intel Health Guide Express, brings the companies another step closer to making the product available for off-the-shelf personal computers.

Filed Under: 510(k), News Well, Software / IT Tagged With: Gift Bans, Intel Corp., Meridian Bioscience Inc., MP Biomedicals LLC, Vasomedical Inc., Ventus Medical Inc.

Sans swine flu, Meridian earnings sink 32 percent

January 20, 2011 By MedCity News Leave a Comment

yy logo

Swine flu fears pushed up demand for Meridian Bioscience Inc.’s (NSDQ:VIVO) rapid flu tests a year ago, but the absence of those concerns contributed to a 32 percent decline in the diagnostic test maker’s first-quarter earnings for fiscal 2011.

It marked the fourth consecutive quarter of declining year-over-year earnings for the West Chester, Ohio, company. The company reported net earnings of $6 million or 16 cents per diluted share.

That fell below analysts’ expectations of 19 cents per diluted share.

Filed Under: Business/Financial News, Diagnostics, MassDevice Earnings Roundup, News Well Tagged With: Meridian Bioscience Inc.

Meridian Bioscience has a squatter — on Twitter

January 11, 2011 By MedCity News Leave a Comment

Meridian logo

It happened to diagnostic test maker Meridian Bioscience Inc. (NSDQ:VIVO), but at least it doesn’t appear to have caused any damage.

Meridian was victimized by a Twitter “name squatter.” That is, someone not affiliated with the company created a Twitter account using its name, logo and references to its website.

Filed Under: Business/Financial News, Diagnostics, News Well Tagged With: Meridian Bioscience Inc.

Meridian Bioscience dives on “disappointing” Q4 results

November 11, 2010 By MedCity News Leave a Comment

MedCity News logo

Diagnostics maker Meridian Bioscience Inc. (NSDQ:VIVO) capped a “disappointing” fiscal 2010 with fourth-quarter profits that fell below Wall Street’s expectations and sent its shares tumbling.

Fourth-quarter profits fell 40 percent to $5.3 million, or 13 cents per diluted share. Excluding special items associated with the costs of an acquisition, per-share earnings came in at 15 cents, according to a statement from the Cincinnati-based company.

Filed Under: Business/Financial News, Diagnostics, MassDevice Earnings Roundup, News Well Tagged With: Meridian Bioscience Inc.

Meridian Bioscience wins Canadian OK for C. difficile test

September 30, 2010 By MedCity News Leave a Comment

MedCity News logo

Meridian Bioscience Inc. (NSDQ:VIVO) obtained a license to begin selling its illumigene C. difficile molecular test in Canada.

C. difficile is a bacterium that can cause symptoms ranging from diarrhea to life-threatening inflammation of the colon. Meridian’s illumigene C. difficile test can detect the presence of the bacteria in a sample and deliver results within an hour, according to Cincinnati-based company.

Filed Under: Business/Financial News, Diagnostics, News Well Tagged With: Meridian Bioscience Inc.

Meridian Bioscience optimistic about about FY 2011

September 13, 2010 By MedCity News Leave a Comment

MedCity News logo

As it rounds out a “very difficult” fiscal 2010, diagnostic test maker Meridian Bioscience Inc. (NSDQ:VIVO) sees better things in 2011.

The Cincinnati, Ohio-based company released optimistic guidance for the upcoming fiscal year. It expects earnings between 77 cents and 82 cents per diluted share, and sales between $165 million and $170 million, according to the company.

Investors liked the sound of those numbers and pushed the company’s stock up about 3.7 percent to $18.86 by late Monday afternoon.

Filed Under: Business/Financial News, Diagnostics, Genomics/Molecular Diagnostics, News Well Tagged With: Meridian Bioscience Inc.

Despite poor earnings, Meridian Bioscience touts purchase of British firm

July 20, 2010 By MedCity News Leave a Comment

MedCity News logo

By Mary Vanac

Meridian Bioscience Inc. (NSDQ:VIVO) acquired the outstanding capital stock of Bioline Ltd., the London, U.K.-based maker and distributor of molecular biology reagents, for $23.3 million in cash.

The company also said Tuesday its profits fell 24 percent in its third quarter from a year ago, because of continuing weakness in respiratory disease test sales caused by a lack of a flu season and competition for sales of C. difficile tests.

Filed Under: Business/Financial News, Diagnostics, MassDevice Earnings Roundup, Mergers & Acquisitions, News Well Tagged With: Meridian Bioscience Inc.

Meridian Bioscience lands FDA clearance for C. difficile test

July 13, 2010 By MedCity News Leave a Comment

MedCity News logo

By Mary Vanacc

Diagnostics company Meridian Bioscience Inc. (NSDQ:VIVO) received the go-ahead from the Food & Drug Administration to sell its first molecular test — illumigene C. difficile.

The Cincinnati life science company has has success making diagnostic test kits that detect pathogens like C. difficile which is a bacterium that can cause diarrhea and, in severe cases, a life-threatening inflammation of the colon.

Filed Under: Business/Financial News, Diagnostics, News Well Tagged With: Meridian Bioscience Inc.

Meridian Bioscience enters exclusive deal with Italian diagnostics firm

July 9, 2010 By MedCity News Leave a Comment

MedCity News logo

By Mary Vanac

Meridian Bioscience Inc. (NSDQ:VIVO) struck an exclusive, world-wide product development and distribution agreement with an Italian diagnostics company that is likely to open doors to new customers in Eastern Europe and Asia.

Filed Under: Business/Financial News, Diagnostics, News Well Tagged With: Meridian Bioscience Inc.

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