HEALTH

GE-Intel venture to focus on new models of care delivery

BY Michael Johnsen

SANTA CLARA, Calif. A new healthcare company focused on telehealth and independent living soon will be created, GE and Intel Corp. announced on Monday.

“New models of care delivery are required to address some of the largest issues facing society today, including our aging population, increasing healthcare costs and a large number of people living with chronic conditions,” stated Intel president and CEO Paul Otellini. “We must rethink models of care that go beyond hospital and clinic visits, to home and community-based care models that allow for prevention, early detection, behavior change and social support. The creation of this new company is aimed at accelerating just that.”

GE and Intel entered into a definitive agreement to form a 50/50 joint venture to create a new company that will be formed by combining assets of GE Healthcare’s Home Health division and Intel’s Digital Health Group, and will be owned equally by GE and Intel. Pending regulatory and other customary closing conditions, the joint venture is expected to become operational by the end of the year. Financial terms were not disclosed.

The new company will focus on three major segments — chronic disease management, independent living and assistive technologies. GE Healthcare and Intel will contribute assets in remote patient monitoring, independent living concepts and assistive technologies, such as the Intel Health Guide, Intel Reader and GE Healthcare’s QuietCare.

The venture builds on the GE-Intel healthcare alliance announced in April 2009 around independent living and chronic disease management. Once formed, the new company will develop and market products, services and technologies that promote independent living both at home and in assisted living communities.

The new company will have headquarters in the greater Sacramento, Calif. area. Louis Burns, currently VP and general manager of Intel’s Digital Health Group, will be CEO of the new company, and Omar Ishrak, SVP of GE and president and CEO, GE Healthcare Systems, will be chairman.

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Bayer Diabetes Care updates devices under National Glycohemoglobin Standardization Program

BY Michael Johnsen

TARRYTOWN, N.Y. Bayer Diabetes Care has successfully completed certification of its A1CNow+ and A1CNow Selfcheck devices under a tighter performance certification standard that went into effect Jan. 1.

The new performance certification standards applicable to devices that measure A1C (or glycated hemoglobin) as set by the National Glycohemoglobin Standardization Program (NGSP) changed to +/-0.75% A1C, 95% CI, 4-10.0% A1C range.

Bayer received a new NGSP certificate valid from July 1, 2010 through July 1, 2011.  The previous criteria for last year’s NGSP certification was +/-0.85% A1C, 95% CI, 4-12.0% A1C range.

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FDA issues warning letter to Abbott Diabetes Care manufacturing plant

BY Michael Johnsen

ROCKVILLE, Md. The Food and Drug Administration earlier this week posted a July 2 warning letter addressing quality concerns at an Abbott Diabetes Care manufacturing plant.

The warning letter outlined some of the specific violations of good manufacturing practices for the manufacturer of the FreeStyle blood glucose meter, including not following through on reports concerning empty blister packs being produced on the Noack Blister Packer at one of Abbott’s establishments. Similarly, an exception report initiated on April 8, 2008, for scratches on FreeStyle Lite strips was closed with no corrective action or effectiveness check, the agency stated.

Abbott is working with the FDA to address the agency’s concerns.

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