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.
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.
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.
Cedars-Sinai Medical Center, Doylestown Hospital and Mt. Sinai Medical Center are all using the iPhone to support paitent care; a doc says “Where I am should not limit what I can do or how I get it done;” an FCC official touts mHealth's healthcare reform and economic benefits; and CardioNet and eCardio post their patient monitoring numbers.
Three iPhone hospitals Cedars-Sinai Medical Center, Doylestown Hospital and Mt. Sinai Medical Center are all using the iPhone to support patient care. Cedars-Sinai created a HIPAA-compliant web portal optimized for the iPhone’s Safari web browser to access patient information and consolidate data from 30 hospital systems for 8,000 of Cedars-Sinai’s workers (and iPhone users). Doylestown Hospital’s workers use the device to access corporate email and a HIPAA-compliant portal for patient data, lab results, images and other clinical data. And Mt.
A pair of three-dimensional imaging technologies brings Avatar-like imagery into the hospital and OR; an "artificial pancreas" using available commercial technology; and ReShape Medical's inflatable gastric balloon goes to trial.
3Di volumetric visualization software wins U.S. clearance: Shina Systems of Caesaria, Israel, won Food & Drug Administration approval to market its medical visualization software. 3Di creates a digital cloud of data from different sources which distributes the images to individual computers throughout a hospital. To optimize access, 3Di splits image processing between the client and server depending on the demands of clinicians. 
Becton, Dickinson & Co. expands the Class I recall of millions of its Q-Syte Luer access intravenous systems to include its Nexiva IV catheter.
Becton, Dickinson & Co. (NYSE:BDX) voluntarily expanded the Class I recall of millions of its Q-Syte Luer access devices to include its Nexiva intravenous catheter systems.
The recall, initiated last October, was prompted by complaints that air was introduced in to device through its septum's bottom disk, potentially leading to air embolisms or leakage that could cause serious injury or death. The Nexiva devices contain two of the Q-Syte components containing the defect, which was caused by a "manufacturing deviation," BD said.
Former CoreValve CEO Dan Lemaitre will lead White Pine Medical, Essex Woodland Health's new private equity investment fund aimed at backing medical device makers.
Dan Lemaitre, the former CEO of CoreValve Inc., will head up Essex Woodlands Health Ventures' new medical device fund, White Pine Medical.
Last year Medtronic Inc. (NYSE:MDT) spent about $700 million, plus a possible $150 million more, buying CoreValve and its aortic valve replacement device. Lemaitre, who was a senior vice president at Medtronic before his stint at CoreValve, spent 28 years as an analyst at SG Cowen and Merrill Lynch, covering the medical device industry.
He'll start his new fund with $50 million from Essex Woodlands, which Lemaitre said is looking to do some bargain hunting.
