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Republicans To Introduce Health Reform Plan That Would Establish State Health Insurance Exchanges, Provide Tax Credits
Congressional Republicans are releasing two health care reform proposals -- one from conservatives and one from moderates -- as alternatives to plans by Democrats, CQ Today reports (Wayne, CQ Today, 5/19). Conservative Plan
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BSD Receives FDA Humanitarian Use Designation For The BSD-2000 Hyperthermia System
BSD Medical Corporation (NASDAQ:BSDM) announced that the U.S. Food and Drug Administration (FDA) has granted Humanitarian Use Device (HUD) designation for the company"s BSD-2000 Hyperthermia System for use in conjunction with radiation therapy for the treatment of cervical carcinoma patients who are ineligible for chemotherapy. This is the first of the two steps required to obtain Humanitarian Device Exemption (HDE) marketing approval, which requires BSD Medical to demonstrate the device"s safety and probable benefit in treating a disease or condition that affects fewer than 4,000 individuals in the United States per year. Now that FDA has granted the Humanitarian Use Designation for the BSD-2000, which confirms that the intended use population is fewer than 4,000 patients per year, BSD can file an HDE submission with the FDA. FDA has 75 days from the date of receipt of the HDE submission to grant or deny an HDE application. This period includes a 30-day filing period during which FDA determines whether the HDE application is sufficiently complete to permit substantive review. During this review, FDA may refine the indications for use which received HUD designation to finalize the indications for use for which HDE approval will be granted. This decision will be based on the data that are available to support the device"s HDE application. The company believes that the data previously submitted to FDA and reviewed by the agency in the company"s pending PMA application can be used to support the HDE approval, and that this previous review may expedite marketing approval for the BSD-2000.
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Being Overweight, Obese During Early Adulthood Associated With Greater Risk Of Pancreatic Cancer
Young adults who are overweight or obese have an increased risk of pancreatic cancer, and being obese at an older age is associated with a lower overall survival rate for patients with pancreatic cancer, according to a study in the June 24 issue of JAMA.
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Introducing The Pioneering XTRAC Velocity™ Excimer Laser: Delivers Psoriasis And Vitiligo Treatments Three Times Faster

PhotoMedex, Inc. (NASDAQ: PHMD), a leader in the development of proprietary excimer laser and fiber optic systems as well as other products for dermatological applications, announced the availability of its groundbreaking XTRAC Velocity™ Excimer Laser, a device expected to redefine laser treatment options for patients suffering from psoriasis and vitiligo. Two separate independent third-party agencies have confirmed that the XTRAC Ultra® laser, precursor to the XTRAC Velocity excimer laser, is the most accurate, powerful, and fastest excimer laser available to date. PhotoMedex has raised the bar even higher with the Velocity laser, which features an average laser power of up to 7.2 watts delivered to the patient. Velocity"s treatment time is nearly three times faster than PhotoMedex" XTRAC Ultra laser. In performance tests the device has been able to treat lesions of 3,500 cm2 (600 mj/cm2) in 4 minutes, 52 seconds*-roughly 1/3 the time required by the Ultra. Because the innovative Velocity excimer laser can cover a much greater surface area in the average treatment session-up to 20% of the body surface in five minutes versus only 2 to 4% for alternative lasers-it is the first practical alternative to potent pharmaceuticals or full-body UV irradiation for patients with severe psoriasis. "The XTRAC Velocity laser is going to be a game-changer for patients and dermatology practices alike," said Jeff O"Donnell, president of PhotoMedex. "For patients, the Velocity will dramatically shorten treatment times, increase the size and number of lesions that can be treated per session, and open laser therapy as a viable alternative for patients who were not necessarily laser candidates in the past. In fact, for busy dermatology practices, the Velocity will make it practical to treat as many as 32 patients per day." New Touchscreen, Handpiece Controls With a maximum repetition rate of 400 Hz and delivered laser energy of 12 to 18 millijoules/pulse, PhotoMedex" XTRAC Velocity is unparalleled in its power and treatment speed. The new laser system has an unparalleled safety profile and is also highly effective with a long duration of remission-yet laser performance is only the beginning of the unit"s advantages. To increase quality of care for patients as well as increase the clinician"s convenience, the Velocity offers a new full-color touchscreen control interface. The screen and built-in database tracking software goes beyond normal equipment operation to incorporate patient information including ID generation, recognition, treatment history, dosing heuristics and more. Also included for the first time on the Velocity is a touch control handpiece that allows the laser treatment to be delivered more easily compared to conventional footswitch-controlled devices. "Profit Per Treatment" Model Like all the excimer lasers in the PhotoMedex line, the Velocity is available to clinics at no direct cost via a unique consignment-based business model. Thanks to the "Profit per Treatment" model, dermatologists provide Velocity laser therapy to their customers, paying a fee only on treatments rendered. In-service training is provided by a dedicated PhotoMedex clinical specialist. Reimbursement support is also provided by a team of direct employee-insurance specialists who continue to receive positive reviews from both office staff and patients for their dedicated and knowledgeable support. Purchase options and financing for PhotoMedex lasers are available as well. * Treatment time calculations do not include the overhead associated with moving the hand piece. PhotoMedex


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