FDA Update - PDF 2 by ProQuest


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									24 Renal & Urology News           JULY 2010      www.renalandurologynews.com

                        Industry News                                   FDA Update and Product News

         FDA Update                                                                              Latest News

  ■ FDA Mulls Application for Prostate Imaging Device
  ProUroCare Medical, Inc., of Minneapolis, Minn., has filed a de novo application        Over the Counter Pain
  with the FDA seeking marketing clearance for its prostate mechanical imaging
  (PMI) device (ProUroScan). This will allow the agency to review and potentially
  classify such systems as Class II devices subject to special controls.
                                                                                         Relief Patches Introduced
   The company’s filing asks the FDA to define mechanical imaging systems as
  devices intended to produce an elastic image of the prostate as an aid in docu-        H    isamitu Pharmaceutical, which has
                                                                                              U.S. headquarters in Torrance,
                                                                                         Calif., has introduced two over-the-
                                                                                                                                     joints associated with arthritis, sprains,
                                                                                                                                     strains, and simple backaches experi-
                                                                                                                                     enced by patients aged 18 years and
  menting abnormalities of the prostate that are initially identified by digital rectal
  examination (DRE).                                                                     counter pain relief patches to the          older, according to the company. Each
                                                                                         American market, the Salonpas Pain          patch contains 10% methyl salicylate
   ProUroScan uses a transrectal probe with pressure sensor arrays and a
                                                                                         Relief Patch and Salonpas Arthritis         and 3% I-menthol as the active phar-
  motion tracking system. The system provides real-time elasticity images of
                                                                                         Pain patch.                                 maceutical ingredients.
  the prostate, the company said. The device can detect and pinpoint nodules
                                                                                           Both patches are formulated to pro-         To introduce the patches, Hisamitsu
  because they differ in hardness from surrounding healthy tissue. In a study            vide temporary relief of mild to moder-     says it will distribute more than two
  published in Urology (2008;71:425-429), researchers showed that PMI results            ate aches and pains of the muscles and      million free samples.
  correlated strongly with DRE findings. The investigators tested PMI and DRE
  results for correlation against a transrectal ultrasound of the prostate guided
  biopsy for a subgroup of 21 men with elevated PSA levels. Of 13 patients with
  biopsy-confirmed malignant nodules, PMI identified 10 of the nodules and DRE
                                                                                         Ultra-Fine Pen Needle for
  identified six. PMI findings were consistent with all eight biopsy-negative cases.
  DRE resulted in one false-positive result in the eight biopsy-negative cases.
                                                                                         Diabetes Patients Debuts
   “The PMI device has the potential to document prostate nodularity by produc-
  ing 3D images of the gland and its internal structures based on their respective
  hardness,” the researchers concluded.
                                                                                         B    ecton, Dickinson and Company
                                                                                              (BD), based in Franklin Lakes, N.J.,
                                                                                         has launched the BD Ultrafine Nano,
                                                                                                                                     owner and co-founder of the Diabetes
                                                                                                                                     Management and Training Centers, Inc.,
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