Medical Device Industry News

UPDATE: Hamburg, Sebelius say reforms of FDA, healthcare system are coming

February 8, 2010 by Erica Harbatkin

Regulatory science must evolve along with advances in the life sciences, according to Food & Drug Administration commissioner Margaret Hamburg, while Health & Human Services secretary Kathleen Sebelius says healthcare reform is not dead yet.

WASHINGTON — As the medical device and pharmaceutical industries develop and hone new technologies, the process for regulating those technologies and products needs to keep pace, Food & Drug Administration commissioner Margaret Hamburg said earlier today at the National Health Policy Conference here.

"Just as biomedical and life sciences research has evolved in the past decade, regulatory science ... must also evolve," Hamburg said.

Speaking before a crowd of about 200 people who braved the approximately two-and-a-half feet of snow that blanketed the Washington region over the weekend, Hamburg said the FDA needs to streamline regulatory procedures, which have not kept pace with innovations throughout the life sciences industry.

Owens & Minor's Q4 sales tick up, earnings soar 60 percent.

February 8, 2010 by MassDevice staff

Medical device distributor Owens & Minor posted a strong fourth quarter, with sales up 4 percent to $2 billion and net income rising to $32 million.

Owens & Minor (NYSE:OMI) posted fourth-quarter sales of $2.04 billion for the three months ended Dec. 31, 2009, up 4.2 percent compared with $1.96 billion during the same period in 2008. Net income rose 60.1 percent to $32.3 million, compared with $20.2 million during Q4 2008:

Charles River Labs: Back in black

February 8, 2010 by MassDevice staff

Wilmington, Mass.-based CRO Charles River Laboratories International Inc. recovers from a rough year, but sales are still sluggish.

Less than a month after it announcing layoffs for 300 workers in Massachusetts, Charles River Laboratories International Inc. (NYSE:CRL) swung to a profit during 2009.

But it's unlikely that anyone at the Wilmington, Mass.-based contract research organization, which announced in January that it will suspend operations at its preclinical services unit in Shrewsbury, was celebrating the return to black ink.

In the fourth quarter of 2008, the company took a massive, non-cash goodwill impairment charge of $700 million, which led it to report a a $525 million loss for the year. Absent the write-down, the 2009 results looked rosier, but only on the surface.

Qiagen's Q4 sales, net earnings rise by double digits

February 8, 2010 by MassDevice staff

Qiagen N.V.'s fourth-quarter sales rose 22 percent to $289 million and net earnings rose 32 percent to $44 million.

Qiagen N.V. (NSDQ:QGEN) posted fourth-quarter sales of $289.1 million for the three months ended Dec. 31, 2009, up 22 percent compared with $237.2 million during the same period in 2008. Net income rose 32 percent to $57.6 million, compared with $43.7 million during Q4 2008:

Press Release

QIAGEN Reports Strong Fourth Quarter and Fiscal 2009 Results

Fiscal 2009 Net Sales Exceed $1 Billion

Zymequest COO charged with murdering wife in their home

February 8, 2010 by MassDevice staff

Keith Rosiello, the COO of Beverly, Mass.-based Zymequest Inc., is charged with murdering his wife in their Shrewsbury home.

Zymequest Inc. COO Keith Rosiello was charged with murdering his wife in their Shrewsbury, Mass., home, according to news reports.

Rosiello, 44, was arrested Jan. 4 and charged with one count of murder in Westborough District Court.

Rosiello called police to his home in Shrewsbury, Mass., on the afternoon of Feb. 4, where they found his wife Maureen Rosiello, 38, on the living room sofa, "deceased and showed obvious signs of traumatic injuries," according to a police report.

Rosiello allegedly told police his wife had stopped breathing following an argument. He was arrested and later charged with murder, according to the Worcester Telegram and Gazette.

Synovis Life Tech's Flow Coupler anastomosis device wins FDA clearance

February 8, 2010 by MassDevice staff

A Synovis Life Technologies Inc. device designed to measure blood flow at anastomosis sites where blood vessels are joined wins clearance from the Food & Drug Administration.

By Brandon Glenn

ST. PAUL, Minnesota — Synovis Life Technologies Inc. (NSDQ:SYNO) received clearance from the Food & Drug Administration for a device that measures blood flow immediately after surgical procedures to connect veins.

SurModics' Q1 sales, earnings plummet

February 8, 2010 by MassDevice staff

First-quarter sales and earnings plummeted 81 and 93 percent, respectively, during the final three months of 2009.

SurModics Inc. (NSDQ:SRDX) posted first-quarter sales of $9.2 million for the three months ended Dec. 31, 2009, down 80.7 percent compared with $47.7 million during the same period last year. Net income fell 93 percent to $1.9 million, compared with $27.1 million during Q1 2009: