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FDA grants marketing clearance for EarlySense's EverOn Central Display Station

EarlySense announced today that its EverOn Central Display Station (CDS) has been cleared for marketing by the U.S. Food and Drug Administration (FDA). The FDA clearance covers the ability of the system to collect real time vital sign information from up to 36 EverOn bedside monitors and display the information on a computer screen at the nurse's station.

5 Oct 2010

$Osseon receives second patent NOA for spinal vertebral compression fracture technology$

Osseon receives second patent NOA for spinal vertebral compression fracture technology

Osseon Therapeutics, Inc., a biomedical device company based in Santa Rosa, California, received its second patent Notice of Allowance (NOA) for its spinal vertebral compression fracture (VCF) technology.

5 Oct 2010

U.S. Social Security Administration selects Accenture to implement emerging technology applications

The U.S. Social Security Administration (SSA) has selected Accenture as a prime contractor under the Information Technology Support Services Contract (ITSSC) that will be used to acquire a wide range of IT systems development and modernization services. The ITSSC includes a one-year base period plus six additional one-year options with an aggregate ceiling valued at $2.8 billion.

5 Oct 2010

Delta Health introduces ClinicalVirtuoso solution to optimize homecare therapist

In response to the growing homecare and therapy markets, and the importance of "aging-in-place" as an alternative solution to institutionalized care, Delta Health Technologies, LLC today announced the introduction of ClinicalVirtuoso the first clinical solution developed to optimize the homecare therapist.

5 Oct 2010

Estech adds COBRA Revolution Bipolar Clamp to ablation product line

Estech, a leading provider of minimally invasive cardiac surgery devices, today announced the launch of its COBRA Revolution™ Bipolar Clamp for use in surgical ablation procedures. The new instrument enables deep transmural lesion formation after a single application and is the only clamp to feature reversible jaws, which uniquely allows surgeons to follow anatomic contours, for unprecedented ease of use and efficiency.

5 Oct 2010

Brothers lead charge for electronic medical records push, but find barriers

The New York Times reports on the Doerr brothers, one a venture capitalist and the other a physicianr and software designer, who are leading the charge to push doctors to use electronic medical records. "It seems straightforward. Just combine technology skills with investment money, and then develop innovative products. But to date, the push for a digital revolution in doctors' offices has brought mostly frustration for the many companies big and small that are trying to conquer the field.

4 Oct 2010

Titan Spine to release new Endoskeleton TC system in first-quarter 2011

Titan Spine announced that it will begin full commercial release of its new Endoskeleton® TC system first quarter of 2011. The Endoskeleton® TC is an interbody fusion device for the cervical spine. The product received 510(k) clearance in July of this year and has been in limited market release since early August. The device has an acid etched titanium surface and is biomechanically designed to promote spinal fusion.

4 Oct 2010

GlobalNet Services awarded $14M contract to support FDA Unified Registration and Listing System

GlobalNet Services, Inc., a premier information technology provider for businesses and the Federal government, today announced that it had been awarded a $14 million contract to support the U.S. Food and Drug Administration's (FDA) Unified Registration and Listing System (FURLS). This five-year contract, which includes one base year and four option years, supports federal initiatives that require all facilities, which manufacture, process or hold FDA-regulated products to be registered with the Agency.

4 Oct 2010

GSA awards Vision-Sciences FSS Contract for flexible endoscopy solutions

Vision-Sciences, Inc. announced today that it has been awarded a Federal Supply Schedule ("FSS") Contract from the General Services Administration ("GSA") for its flexible endoscopy product lines. The contract period is from October 15, 2010 – October 14, 2015. This GSA contract enables access to the company's technology for all federal healthcare facilities, including the Veterans Administration, Indian Health Service, and Department of Defense facilities.

4 Oct 2010

Public hospitals in two Australian states acquire GreenLight HPS laser consoles for BPH treatment

American Medical Systems, a leading provider of world-class devices and therapies for male and female pelvic health, today announced that eight GreenLight HPS® laser consoles have been acquired for public hospitals in the Australian states of Victoria and Queensland. The laser technology will treat patients with Benign Prostatic Hyperplasia (BPH), a non cancerous enlargement of the prostate experienced by 50 percent of men over 60.

4 Oct 2010

X-rays increase risk of developing childhood leukemia

Diagnostic X-rays may increase the risk of developing childhood leukemia, according to a new study by researchers at the University of California, Berkeley's School of Public Health.

4 Oct 2010

Massachusetts eHealth Institute names e-MDs as EHR vendor and IOO

e-MDs, an industry leader in the development and implementation of electronic health record (EHR) and practice management (PM) solutions, announced they have been named a selected EHR vendor and Implementation Optimization Organization (IOO) by the Massachusetts eHealth Institute (MeHI). The Institute will serve as a Regional Extension Center (REC) in Massachusetts, working to facilitate the adoption of EHR technology by the state's providers. As a selected vendor, e-MDs will help ensure effective implementation and provider achievement of Meaningful Use.

4 Oct 2010

FDA clears DFine's new percutaneous radiofrequency ablation device for metastatic spinal lesions

DFine, Inc., developer of minimally invasive solutions for the treatment of vertebral pathologies, announced today the 510(k) clearance of a new platform extension indicated for the palliative treatment of cancer patients. The product, a percutaneous radiofrequency ablation (RFA) device, provides localized tumor necrosis of vertebral body lesions where metastatic disease has spread to the spine causing severe pain and discomfort.

4 Oct 2010

FDA approves NovaBone Putty MIS Delivery System for orthopedic surgery

NovaBone Products, a medical device company, today announces the U.S. Food and Drug Administration's (FDA) approval of the NovaBone Putty® MIS Delivery System designed for use in minimally invasive orthopedic procedures.

4 Oct 2010

Agile completes enrollment in AG200-15 Phase 3 contraceptive patch study

Agile Therapeutics, Inc., a pharmaceutical development company specializing in women's healthcare products, today announced the Company has completed patient enrollment in its pivotal, Phase 3 NEW CHOICE Study of AG200-15, Agile's lead contraceptive patch. Agile's NEW CHOICE Study enrolled 1500 women at over 100 sites throughout the U.S. The study is comparing the efficacy and tolerability of AG200-15 to a low-dose, oral contraceptive.

4 Oct 2010

NextGen Ambulatory EHR version 5.6 SP1 achieves ONC-ATCB 2011/2012 certification

NextGen Healthcare Information Systems, Inc., a wholly owned subsidiary of Quality Systems, Inc. and a leading provider of healthcare information systems and connectivity solutions, announced today that NextGen® Ambulatory EHR version 5.6 SP1 is 2011/2012 compliant and was certified as a Complete EHR on September 30, 2010 by the Certification Commission for Health Information Technology (CCHIT®), an ONC-ATCB, in accordance with the applicable eligible provider certification criteria adopted by the Secretary of Health and Human Services.

4 Oct 2010

Integra LifeSciences launches EGR system in the U.S.

Integra LifeSciences Holdings Corporation announced today the launch of the Integra™ Endoscopic Gastroc Release (EGR) System in the United States. Integra's EGR System is a disposable device with a unique articulating blade that allows selective cutting of soft tissues. It is intended for use in the surgical treatment for posterior heel cord, or equinus, contracture.

4 Oct 2010

Pharmatek adds roller compaction to GMP manufacturing facilities

Pharmatek Laboratories, Inc., a premier contract development and manufacturing organization supporting the pharmaceutical industry, announced that it has added roller compaction to its solid oral dosage form manufacturing capabilities. The company has purchased two roller compactors, a pilot-scale Vector TFC-220 roller compactor with a rate of 20 kg/hour, and a Vector TFC-LAB Micro lab-scale roller compactor with a rate of 1 kg/hour. Both machines have been integrated into Pharmatek's GMP facility and are ready for GMP manufacturing.

4 Oct 2010

Puerto Rican's awarness of genetic testing high, but usage low

Awareness of genetic testing was higher among adults in Puerto Rico compared to previous U.S. population-based studies, while use of genetic testing was lower, according to data presented at the Third AACR Conference on the Science of Cancer Health Disparities, held Sept. 30 to Oct 3, 2010.

4 Oct 2010

Cost-effective ways for early detection of 'lazy eye'

Amblyopia, known as "lazy eye," is a major cause of vision problems in children and a common cause of blindness in people aged 20 to 70 in developed countries. In amblyopia the person's stronger eye is favored and his/her weaker eye gradually loses visual power as a result. When the condition is detected and treated before age 7, more than 75 percent of children achieve 20/30 vision or better, the Amblyopia Treatment Study reports.

4 Oct 2010