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CryoPatch SG pulmonary human cardiac patch receives FDA clearance for 5-year shelf-life extension

CryoLife, Inc., an implantable biological medical device and cardiovascular tissue processing company, today announced that it has received 510(k) clearance from the Food and Drug Administration (FDA) for a five-year shelf-life on its CryoPatch® SG pulmonary human cardiac patch processed with the Company's proprietary SynerGraft® technology. CryoLife's SynerGraft technology is designed to remove allogeneic donor cells and cellular remnants from tissue without compromising the integrity of the underlying collagen matrix.

9 Aug 2010

Sparton Medical Systems acquires Delphi Medical's contract manufacturing business assets

Sparton Corporation, a supplier of complex and reliable electronic and electro-mechanical products, sub-assemblies and related services to the highly regulated Medical, Defense & Security, and Aerospace markets announces that on August 6, 2010 its wholly owned subsidiary, Sparton Medical Systems Colorado, LLC, completed its previously announced acquisition of certain assets related to the contract manufacturing business of Delphi Medical Systems, LLC. The all-cash transaction is valued at approximately $8.0 million.

9 Aug 2010

Chindex first-quarter revenue from Healthcare Services division increases 12.3% to $24.7 million

Chindex International, Inc., a leading independent American provider of Western healthcare products and services in the People's Republic of China, today announced financial results for the first quarter of fiscal year 2011, which reflects the three month period ended June 30, 2010.

9 Aug 2010

Cegedim Dendrite, Capgemini to offer software solutions for Life Sciences companies

Cegedim Dendrite, the world's leading provider of pharmaceutical-specific Customer Relationship Management solutions, and Capgemini U.S. LLC ("Capgemini"), one of the world's foremost providers of consulting, technology and outsourcing services, announced an alliance to jointly offer software solutions, consulting and technology services around aggregate spend and customer master data to Life Sciences companies. Through the alliance, Capgemini will provide broad based consulting and implementation services associated with Cegedim Dendrite's AggregateSpend360™ and Nucleus 360™ solutions to pharmaceutical, biotech and medical device companies.

9 Aug 2010

Ingen reports 1,200% increase in sales for fiscal 2010

Ingen Technologies, Inc., an emerging medical device manufacturer developing innovative solutions for the respiratory market, with a new patented and proprietary medical product line targeting the $8 billion respiratory market, today announced that its Annual Report has been filed with the OTC Markets, while auditors have completed and filed required restatements needed to return to "fully reporting" status.

7 Aug 2010

Scientists develop hand prosthesis that eases phantom pain

The pain of losing a body part is twofold, as the patients not only suffer from wound pain. Often they are also affected by so called phantom pain. Unlike bodily wounds which will eventually heal, phantom pain often lasts for years and sometimes a lifetime. "Phantom pain is very difficult to treat", says Professor Dr Thomas Weiss from the Friedrich-Schiller-University Jena.

7 Aug 2010

FDA proposed rules address industry, consumer concerns

The Food and Drug Administration may tighten rules for approving medical devices that are only slightly different from already-blessed products, The Chicago Tribune reports.

6 Aug 2010

FDA issues comprehensive evaluations that address key objectives of agency's public health mission

The U.S. Food and Drug Administration today issued two comprehensive evaluations containing recommendations that address three key objectives of the agency's public health mission as it relates to medical devices – foster device innovation, create a more predictable regulatory environment, and enhance device safety.

5 Aug 2010

ECRI Institute and Silverchair relaunch AHRQ's updated NGC, NQMC Web sites

ECRI Institute, an independent nonprofit that researches the best approaches to improving patient care, and its technology subcontractor, Silverchair, today announce the relaunch of two key healthcare Web sites they have developed for the U.S. Agency for Healthcare Research and Quality (AHRQ). The National Guideline Clearinghouse™ (NGC™), www.guideline.gov, and the National Quality Measures Clearinghouse™ (NQMC™), www.qualitymeasures.ahrq.gov, now feature updated design elements, enhanced search functionality, and easier access to all content.

5 Aug 2010

FDA to crack down on devices; Big pharma places riskier bets on biologics

The Associated Press: "Makers of X-ray machines, drug pumps and other medical devices would have to submit more safety information to win federal approval under a proposal designed to tighten regulation of thousands of products reviewed each year. The Food and Drug Administration released recommendations Tuesday night designed to improve oversight of the U.S. device industry, including the government's ability to revoke approval for products that prove unsafe or ineffective" (Perrone, 8/3).

5 Aug 2010

Scientists invent Global Focus microscope for tuberculosis diagnosis

A compact microscope invented at Rice University is proving its potential to impact global health. In a paper published online today in the journal PLoS ONE, Rice alumnus Andrew Miller and co-authors show that his portable, battery-operated fluorescence microscope, which costs $240, stacks up nicely against devices that retail for as much as $40,000 in diagnosing signs of tuberculosis.

5 Aug 2010

TSO3 second-quarter net loss decreases to $1.9 million

TSO3 Inc. an innovator in sterilization technology for medical devices in healthcare settings using ozone, posted revenues of $494,353 for the sales of new generation sterilizers (STERIZONE(R) 125L+ / 3M(TM) Optreoz(TM) 125-Z), accessories and service contracts. This compares to $510,626 for the same period in 2009, representing the sale of two of the first generation ozone sterilizers (125L), accessories and service contracts, as well as a large installation contract.

4 Aug 2010

BioClinica second-quarter service revenues increase to $15.7 million

BioClinica, Inc., a global provider of clinical trial management services, today announced its financial results for the second quarter and six months ended June 30, 2010.

From Clario 4 Aug 2010

MAKO Surgical second-quarter total revenue increases 151% to $10.3 million

MAKO Surgical Corp., a medical device company that markets both its RIO® Robotic Arm Interactive Orthopedic surgical platform and proprietary RESTORIS® implants for minimally invasive orthopedic knee procedures known as MAKOplasty®, today announced its operating results for its second quarter ended June 30, 2010.

4 Aug 2010

IL releases new HemosIL HIT-Ab(PF4-H) assay

Instrumentation Laboratory (IL) today announced the release of the new HemosIL HIT-Ab(PF4-H) assay as a European CE IVD Mark product under the European Directive on In Vitro Diagnostic Medical Devices. Delivering results in minutes, the HemosIL HIT-Ab(PF4-H) assay detects total immunoglobulin against Platelet Factor 4-Heparin complexes, the antibodies associated with the pathology of HIT.

4 Aug 2010

Mass. towns find savings in municipal-based health insurance plans; Conn. hospitals' earnings improve; Free dental clinic in Virginia

"Fourteen cities and towns that have moved their employees, retirees, and elected officials from their own municipal-based health care insurance plans into the state's much larger, more flexible system collectively saved more than $30 million their first year in the program, according to a new report. … The study relies on self-reported fiscal data on the communities' first year in the Group Insurance Commission, the state health care program, which covers some 300,000 state employees, retirees, and elected officials" (Murphy, 8/3).

4 Aug 2010

Biomedical engineering professor receives patent for Electromagnetic Probe Device

The United States Patent Office has issued a patent to Dr. Mark DeCoster, associate professor of biomedical engineering at Louisiana Tech University, for his invention of an "Electromagnetic Probe Device" - an innovative technology developed at Louisiana Tech's Institute for Micromanufacturing.

4 Aug 2010

GE and Intel create new health IT venture focused on home-based care

General Electric Co. and Intel Corp. announced Monday they will create a company to provide new medical technologies for the elderly and chronically ill.

4 Aug 2010

AGA Medical second-quarter 2010 net sales increase 7.6% to $53.8 million

AGA Medical Holdings, Inc., a leading developer of interventional medical devices for the minimally invasive treatment of structural heart defects and vascular abnormalities, today reported financial results for the second quarter ended June 30, 2010.

3 Aug 2010

STERIS first-quarter revenues increase 3% to $291.3 million

STERIS Corporation today announced financial results for its fiscal 2011 first quarter ended June 30, 2010. During the first quarter, the Company recorded the previously announced liability related to the SYSTEM 1 Rebate Program. Of the $110 million pre-tax amount recorded, $102 million is attributable to the Customer Rebate portion of the Program and was recorded as a reduction of revenues, and $8 million is attributable to the disposal of the SYSTEM 1 units to be returned and was recorded as an increase in cost of revenues.

3 Aug 2010