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The Medical Industry Business Weekly |
| August 28, 2008 |
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Other HeadlinesCompany warns hospitals about unvalidated FirstCall probe files.
UnitedHealth Group of Minneapolis extends imaging accreditation deadline to the fourth quarter of 2009.
CMS releases guide to improve access to navigating Medicare requirements for approving innovative technologies.
Group of organizations discussed radiation dose used in scans performed on children at recent gathering.
With today's technology and treatments, doctors can find and fix osteoporosis.
Have News for Us?Submit your news on the industry, people, or companies.More Industry HeadlinesSonora Medical Systems Warns of Illegal Software Modifications Company warns hospitals about unvalidated FirstCall probe files. Imaging Accreditation Deadline Extended by UnitedHealth Group UnitedHealth Group of Minneapolis extends imaging accreditation deadline to the fourth quarter of 2009. Medicare May Approve Advanced Technologies Faster CMS releases guide to improve access to navigating Medicare requirements for approving innovative technologies. Alliance for Radiation Safety in Pediatric Imaging Held Pediatric CT Vendor Summit Group of organizations discussed radiation dose used in scans performed on children at recent gathering.
LAST CHANCE -- PHILIPS Duo Diagnost Remote R/F Room So get your bids in early this week...if you "snooze," you could "lose" out on a great deal on just the system you want! Doctors Get Treatment Right the First Time With a Virtual Heart Doctors could soon be able to perform minimally invasive surgery on virtual versions of people's hearts to help ensure they make the best decisions for their patients before doing the procedure for real. AMA Concerned: New ICD-10 Proposed Rule a Burden for Physicians Physicians' group worries about administrative burden of proposed reimbursement coding system. FDA, EMEA Will Consider Additional Toxicity Tests in Reviewing Drug Safety New joint effort might result in better detection of cellular damage. Abbott Laboratories Will Eliminate Approximately 1,000 Jobs Abbott Laboratories Inc. will eliminate about 1,000 jobs over the next four years as part of a plan to streamline operations and cut costs in its medical diagnostics business. GE Healthcare and Hologic Talk About Fan Beam Technology OEM briefings on the latest bone densitometry innovations. 
Global
Harmonization Task Force Hong Kong Offers Tips on Listing Medical Devicesby Joan Trombetti, Writer
Manufacturers of medical devices approved for marketing in one or more of the Global Harmonization Task Force's founding member jurisdictions by Dec. 31, 2004, may skip a key requirement for listing their products in Hong Kong, a recent directive from the Medical Device Control Office says.
Applicants whose products received authorization by that date in the U.S., EU, Canada, Japan or Australia are not required to complete a form MD-CCL: Essential Principles Conformity Checklist, according to the notice. Firms that previously have prepared the Essential Requirements Checklist in accordance with the EU's Medical Devices Directives and "have sufficient evidence that their products also comply with the MDACS [Medical Device Administrative Control System] requirements" may submit the checklist and a declaration of conformity in place of the MD-CCL, the notice says. Certificates from recognized conformity assessment bodies in other jurisdictions must demonstrate compliance with the MDACS requirements for conformity assessment. Those applications should include the MD-CCL, a risk analysis summary and clinical trial data. "Supplementary Notes for Submitting Applications for Listing Medical Devices Under the Medical Device Administrative Control System" is available at www.mdco.gov.hk/english/mdacs/mdacs_gn/files/supp_notes_20080611.pdf. 
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