Category: Swine Flu

FDA issues warnings, recall

February 3, 2010 by MassDevice staff

The Food & Drug Administration issues a pair of warnings to Millipore Corp. (NYSE:MIL) and Cardiac Sciences Corp. (NSDQ:CSCX) and put out a Class I recall of Synthes USA's (SIX:SYST) Synex II vertebral implant.

Millipore warned on Swine Flu diagnostics claims

The FDA sent the Billerica, Mass.-based lab instruments maker a warning letter in September of last year about a promotional email the company sent out touting its influenza diagnostics.

Quest Diagnostics: Swine Flu declined 75 percent since October peak

December 18, 2009 by MassDevice staff

Kissing under the mistletoe might be back on this Christmas, as long as whoever you're kissing is a willing participant.

That's because the threat of Swine Flu putting a damper on the holidays may be fading, according to Quest Diagnostics Inc. (NYSE:DGX), which says that reports of the H1N1 influenza virus are down 75 percent since an October peak.

The Madison, N.J.-based company's "H1N1 Testing in America: End of the Second Wave?" report follows similar news put out in November by Quest, which said then that Swine Flu peaked in October.

Swine Flu threat may have peaked, study finds

November 20, 2009 by MassDevice staff

In its monthly "Health Trends" report released Nov. 20, researchers at Quest Diagnostics Inc. found that demand for the company's 2009 H1N1 influenza virus test kit started to slide since Oct. 27. Positive test results also began to drop across most age groups and in most regions of the country, according to the report.

There were two important exceptions to the otherwise positive news. Infection rates continued to grow in the Northeast, more than doubling during the two weeks ended Nov. 10 compared with the prior two weeks. Swine Flu also remains a significant risk to older adults, with the rate of infection tripling in people over age 65 since late August, the study found.

UPDATE: CDC taps GE Healthcare to track Swine Flu

October 29, 2009 by MassDevice staff

GE Healthcare and the Centers For Disease Control struck a one-year deal to set up what the healthcare conglomerate calls a "real-time" monitor of Swine Flu activity in the United States.

Inverness swings into the black during the third quarter

October 27, 2009 by MassDevice staff

Inverness Medical Innovations Inc. put some black ink on its balance sheet during the third quarter, logging a 22.1 percent increase in revenues compared with Q3 2008, largely on a jump in sales of its influenza diagnostic tests and contributions from acquisitions.

FDA authorizes Quest Diagnostics/3M "real-time" Swine Flu molecular test combo

October 16, 2009 by MassDevice staff

The U.S. Food and Drug Administration granted emergency use authorization for the use of Quest Diagnostics' Simplexa 24-hour Swine Flu test on equipment made by 3M, in a move aimed at boosting lab capacity for the test during flu season.

Another study shows rapid tests miss Swine Flu

September 24, 2009 by MassDevice staff

Another study showing the ineffectiveness of rapid tests for Swine Flu has the Centers for Disease Control advising doctors and patients not to bother with the tests at all, the Reuters news service reported.

A study by researchers at Connecticut's Greenwich Hospital and Greenwich Dept. of Health found that Thermo Fisher Scientific's Remel Xpect Flu A&B rapid test missed 53 percent of cases later confirmed by genetic tests.