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Unisense FertiliTech A/S Receives CE Mark Of Approval For EmbryoScope(TM) Embryo Monitoring System
Unisense FertiliTech A/S announces that the EmbryoScope(TM) Embryo Monitoring System and EmbryoSlide(TM) tray have received CE approval as class IIa medical devices for use in IVF. Unisense Fertilitech A/S also received the DS/EN ISO13485:2003 and AC:2007 quality system certificate for production, installation and servicing of IVF incubators and related accessories.
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Health Information Technology Lobby Group Rallies Support For Certification Group; Critics Question Group's Ties
The Healthcare Information and Management Systems Society has asked HHS to give the Certification Commission for Healthcare Information Technology authorization to determine which electronic health records systems can receive funding from the economic stimulus package, the Washington Post reports. In a letter dated April 27 to HHS officials, HIMSS officials wrote, "To ensure continuity, recognize CCHIT as the certifying body" of EHRs.Some health care industry officials have raised issue with giving CCHIT the responsibility of certifying EHR products because of the commission"s associations with various IT and health care companies, the Post reports. CCHIT has ties with HIMSS, which played a role in its inception in 2004 and is now managed by Mark Leavitt, the former chief medical officer of HIMSS. In 2005, the commission received a three-year, $7.5 million contract from HHS.According the Post, Internal Revenue Service tax documents show that HIMSS technically paid Leavitt"s salary through 2008, which was reimbursed by CCHIT. However, Leavitt said he is accountable only to CCHIT"s board members and he "was not supervised by HIMSS." He said he expects CCHIT will be "the body or one of several certifying bodies that are recognized" by HHS in part because it already is tasked with certifying health IT products. According to Leavitt, some of the commission"s critics are IT vendors who have failed to meet CCHIT"s standards. The Post reports that the provision in the stimulus package that requires health care providers to demonstrate "meaningful use" of health IT has become an issue because federal officials, IT systems vendors, and physicians and patient advocates have not been able to reach a consensus on the definition of meaningful use. Under the provision, providers must demonstrate meaningful use of health IT in order to receive Medicare and Medicaid incentive payments for adopting the technology (O"Harrow, Washington Post, 5/21). Blumenthal
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Dietary Fat, Especially From Red Meat, Dairy, Linked To Pancreatic Cancer
New research from the US that studied the diet and health outcomes of over half a million people suggests that high consumption of dietary fat,
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BioElectronics Prepares For General Surgical Recovery FDA 510(k) Premarketing Application Submission

BioElectronics Corp. (PINKSHEETS: BIEL), the maker of inexpensive, disposable drug-free anti-inflammatory devices, announced the Company is currently preparing an application for 510(k) premarket notification for submission to the Food and Drug Administration (FDA) for general surgical recovery. The filing will request an indication for the adjunct of use in palliative treatment of postoperative edema and pain in superficial soft tissue. "There is overwhelming clinical data demonstrating the application of PEMF therapy significantly reduces postsurgical edema (swelling), pain and speeds healing. There are currently several devices cleared for this indication of use, but these devices are very large, expensive and are in no way portable, so they are neither practical nor marketable for surgical recovery. BioElectronics" portable version of PEMF, for which we recently were granted a patent, is very different. Our biomedical engineers have been able to shrink PEMF technology into a wearable patch that can be applied directly over the site of surgery," commented Andrew Whelan, CEO of BioElectronics. "Many surgeons are already using our products as an adjunctive therapy in the post-operative environment to speed healing and to significantly reduce, or in many cases, completely eliminate the use of narcotics, Tylenol® or acetaminophen, and NSAIDs to control surgical related pain within their patient populations." BioElectronics Corp."s RecoveryRX™ devices have already received FDA clearance for the treatment of edema following blepharoplasty, a common plastic surgery procedure. Gaining this additional FDA indication will allow the Company to market its products for use in the general surgical market, which consists of hundreds of thousands of procedures performed each year in both the ambulatory and outpatient environments. The Company recently filed with FDA for clearance to market its Allay™ Menstrual Pain Relief Patch product and is currently in process of completing numerous clinical trials designed to support additional marketing clearance applications with FDA. BioElectronics Corporation


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