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 News    July 3, 2009
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First Human Receives Cardiac Stem Cells in Clinical Trial to Heal Damage Caused By Heart Attacks
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Heart Attack Patient Receives His Own Heart Stem Cells as Part of Medical Study to Determine Safety of New Technique to Repair Injured Heart Muscle


Infants Should Be Screened for Hip Trouble
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Developmental hip dysplasia is the most common congenital defect in newborns. The condition occurs when a hip joint is shallow, unstable or when the joint is dislocated.


New EPI Healthcare Study by June O'Neill Shows Uninsured 'Crisis' Wildly Overestimated
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Former CBO Director and Member of the President's Council of Economic Advisors' Authors New Report Titled "Who are the Uninsured?"


Dr. Donnica Moore Advocates that Women Follow a Preventive Dental Health Routine that Includes Crest Pro-Health Enamel Shield
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Leading women's health expert, Donnica L. Moore , MD, wants women to know that their dental health is important to their overall wellness. She recommends Crest and Oral-B Pro-Health products because they offer preventive solutions that can be easily integrated into a daily health regimen.


High Incidence of Obstructive Sleep Apnea in Suburban Dental Practices
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In a recent study published in the journal Sleep and Breathing, Dr Todd Morgan and others showed that the prevalence of obstructive sleep apnea (OSA) may be higher than expected in suburban dental practices.


 
 
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  Health Care Reform Details Emerge with 'Play or Pay' Requirements, Leaving Some Wondering about Small Business Owner Insurance
UDENT News on Friday, July 03, 2009 9:15 AM

As the health care reform details emerge, more entrepreneurs are wondering about health insurance for small groups and business insurance premiums. Now, they are getting some answers and are turning ...

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  Johnson & Johnson Completes Initial Tender Offer for Cougar Biotechnology
UDENT News on Friday, July 03, 2009 9:14 AM

Johnson & Johnson today announced that the initial offering period of its tender offer for all outstanding shares of common stock of Cougar Biotechnology, Inc.

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  Health Care Reform and Chronic Disease
UDENT News on Thursday, July 02, 2009 7:08 PM

In response to Congress' debate on health care reform, state and local leaders from Maryland joined together at the Baltimore Medical System at Saint Agnes Hospital Community Care Center to call f...

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  High Incidence of Obstructive Sleep Apnea in Suburban Dental Practices image
UDENT News on Thursday, July 02, 2009 8:56 AM

In a recent study published in the journal Sleep and Breathing, Dr Todd Morgan and others showed that the prevalence of obstructive sleep apnea (OSA) may be higher than expected in suburban dental pr...

Read More
 
  Pennsylvania Patient Safety Authority Releases June Advisory
UDENT News on Thursday, July 02, 2009 8:40 AM

wo hospitals in southeast Pennsylvania have successfully reduced or eliminated healthcare-associated infections (HAIs) for intensive care patients in their facilities and are featured in the Pen...

Read More
 
  Dr. Donnica Moore Advocates that Women Follow a Preventive Dental Health Routine that Includes Crest Pro-Health Enamel Shield
UDENT News on Wednesday, July 01, 2009 11:14 AM

Leading women's health expert, Donnica L. Moore , MD, wants women to know that their dental health is important to their overall wellness. She recommends Crest and Oral-B Pro-Health products be...

Read More
 
  New EPI Healthcare Study by June O'Neill Shows Uninsured 'Crisis' Wildly Overestimated
UDENT News on Wednesday, July 01, 2009 9:40 AM

Former CBO Director and Member of the President's Council of Economic Advisors' Authors New Report Titled "Who are the Uninsured?"

Read More
 
  Align Technology to Announce Second Quarter Fiscal 2009 Results on July 23, 2009
UDENT News on Wednesday, July 01, 2009 9:07 AM

Align Technology, Inc., the inventor of Invisalign(R), announced today that the Company will report second quarter 2009 financial results on Thursday, July 23, 2009 after the close of market.

Read More
 
  Stemedica Discovers Significant Breakthrough in the Use of Stem Cells and Stem Cell Factors for the Treatment of Retinal Degeneration image
UDENT News on Wednesday, July 01, 2009 9:06 AM

Stemedica Cell Technologies, Inc., a leader in the manufacturing and development of clinical grade allogeneic adult stem cell technology, has discovered a significant breakthrough in the use of human...

Read More
 
  Dental Network of America (DNoA) Acquires DenteMax, Owned by Blue Cross Blue Shield of Michigan
UDENT News on Wednesday, July 01, 2009 9:05 AM

Dental Network of America, LLC (DNoA) announced today the completion of its acquisition of DenteMax, an independent subsidiary of Blue Cross Blue Shield of Michigan (BCBSM).

Read More
 
  More than One-Third of Docs Say Risk Level Rising for Potential H1N1 Flu Pandemic
UDENT News on Wednesday, July 01, 2009 9:02 AM

new national study among 696 physicians revealed that more than one-third of physicians (37%) reported that there was "somewhat of a risk" that the H1N1 swine flu could result in a catastrophic pan...

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  LeadConfirm Professional, the first oral based lead test, makes getting the lead out easier. ''Aimed for the professional market, LeadConfirm Professi image
UDENT News on Wednesday, July 01, 2009 9:01 AM

Until now, determining a person’s lead exposure has been an invasive procedure involving painful blood tests. However, that has changed thanks to LeadConfirm Professional, a new saliva-based test t...

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Page:   of 47 
 
 

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FDA Approves Diaphragm-Pacing Device

Device can help paralysis patients breathe without a ventilator for at least four hours

The U.S. Food and Drug Administration today announced that it approved the NeuRx DPS RA/4 Respiratory Stimulation System, an implantable electronic device that stimulates the diaphragm and allows certain spinal cord injury patients to breathe for at least four hours a day without a mechanical ventilator.

Spinal cord injuries can cause paralysis, which can impact the muscles of the chest and abdomen, including the diaphragm—the lower abdominal muscle essential for breathing. Normally, a person inhales when the diaphragm contracts and the lungs expand with air—a person exhales when the diaphragm relaxes and the air flows back out of the lungs.

"While the NeuRx RA/4 does not cure paralysis of the diaphragm, allowing patients to be free from a mechanical ventilator for at least four hours a day may enhance their quality of life," said Daniel G. Schultz, M.D., director of the FDA's Center for Devices and Radiological Health.

Patients with severe spinal cord injuries who cannot control their diaphragms often need mechanical ventilation to help them breathe. This usually requires a full-time connection to a ventilation machine.

The NeuRx DPS RA/4 uses four electrodes implanted in the muscle of the diaphragm to electronically stimulate contraction; this stimulation allows the patient to inhale.

The FDA approved the distribution of this device under a Humanitarian Device Exemption, an approval process for devices intended to treat or diagnose conditions that affect fewer than 4,000 people per year.

In a multi-center trial, the device has been demonstrated to be safe and to have probable benefit to the patient by allowing at least four hours per day of freedom from a mechanical ventilator.

NeuRx DPS RA/4 is manufactured by Synapse Biomedical of Cleveland, Ohio.


Posted on Wednesday, June 18, 2008 (Archive on Wednesday, July 16, 2008)
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