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  • Regulatory NewsRegulatory News

    FDA Announces Third-Party Review Pathway for Tumor Profiling Tests

    The US Food and Drug Administration (FDA) on Wednesday announced it has cleared a next-generation sequencing (NGS) test developed by Memorial Sloan Kettering Cancer Center (MSK) that can detect 468 unique gene mutations and other molecular biomarkers in a patient's tumor. The test, referred to as MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets), was already approved for use with samples from patients in New York by the New York State Department of ...
  • Regulatory NewsRegulatory News

    FDA Classifies Post-Concussion Test

    Months after clearing the first computer-based test intended to measure cognitive function after a suspected concussion, the US Food and Drug Administration (FDA) on Monday said it considers such devices to be Class II, or moderate risk devices. In August, FDA cleared ImPACT Applications' Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) and ImPACT Pediatric devices via its de novo classification pathway, as no similar devices had been previously cl...
  • Regulatory NewsRegulatory News

    FDA Clears Test for Measuring Post-Concussion Cognitive Function

    The US Food and Drug Administration (FDA) on Monday announced it cleared the first computer-based tests for measuring cognitive function after a suspected concussion in both adults and children. Concussions have been a growing concern in recent years, as a growing body of evidence suggests the potential for concussions to have long-term health implications, especially in sports such as football and ice hockey where players are at a high risk for head injuries in both pra...
  • Dueling Reports Suggest Economic Impact of Regulations Uncertain

    • 17 April 2012
    • By
    Two reports issued in April paint markedly different pictures about the effects of regulatory policies on the broader economy. The first, a report commissioned by the US Chamber of Commerce (CoC), a politically powerful trade coalition of businesses, found that concerns about "over-regulation" were "the highest we've seen in the past year." CoC's study of its 536 member and 803 non-member small businesses found 42% of small businesses citing "over-regulation" as their h...