Ansar - Development and FDA Clearance History

Development and FDA Clearance History


  • In 1984 :
  • Ansar's predecessor company, Medic Monitor, Inc., was founded to provide research and development funding for the acquisition of an exclusive global license to manufacture and market an innovative, next generation patient monitoring system technology developed by medical researchers at Massachusetts Institute of Technology (MIT).

  • During 1989 :
  • A US patent was issued for the company's first product--the Ansar ANS-C3000. Utilizing the MIT technology, the ANS-C3000 became the first real-time machine to monitor the autonomic nervous system. Upon issue of the patent, the ANS-C3000 was placed at the Cleveland Clinic to perform protocol tests on the unit's performance capability.

  • On October 26th, 1991 :
  • The technology was formally introduced to the medical community at the Cardiac Anesthesiology Association Meeting. Following this introduction, Ansar and its technology were represented at several important medical meetings, including:

    1992  Cleveland Clinic Conference
    1993  Johns Hopkins Medical Conference
    1994  Harvard Medical School Conference.

  • In 1994 :
  • Ansar applied for FDA 510(k) clearance for its new autonomic nervous system monitoring technology.

  • In 1995 :
  • FDA 510(k) clearance was granted.

  • In 1999 :
  • Two (2) reimbursable CPT codes for autonomic nervous system monitoring (95921 & 95922) became effective.

  • In 2000 :
  • The ANS-R1000--a non-invasive, real-time, digital monitor of autonomic nervous system functioning--was launched on the market.

  • In 2004 :
  • Ansar introduces the ANX 3.0 (the evolution of the ANS-R1000) - the latest generation of our non-invasive, real-time, digital monitor of autonomic nervous system functioning, which monitors both branches of the Autonomic Nervous System simultaneously.

  • 2001 - 2004 :
  • Many published abstracts show how valuable and unique Ansar's ANS monitoring is, including :

    2001 Neonatology Abstract
    Ansar ANS monitoring detects bradycardia sooner than other bedside monitors. ANS assessment during sucking, swallowing and breathing can be an objective indicator of maturity.

    2001 American Heart Association Abstract
    A repeat of the ValHeft Study was repeated under Drs. Sonnenblick and LeJemtel. Ansar ANS monitoring was found to pre-identify patients more responsive to double rather than triple neurohormonal blockade therapy.

    2002 NASPE Abstract
    Validates Ansar's wavelet-based ANS monitoring technique. This technique profiles the ANS and has been shown to have prognostic value in patients with myocardial infarction, CHF and diabetes.

    2003 American Heart Association Abstract
    Ansar's ANS monitoring sympathetic profiling identified orthostasis more readily than other heart rate variability parameters and physician diagnosis. Given the known variability in identifying orthostasis, sympathetic profiling could become a requisite component of its definition.

    2003 EEG and Clinical Neural Science Abstract I
    Ansar's ANS monitoring provides an independent, objective means of monitoring both ANS branches at the same time. Recent findings from concurrent parasympathetic and sympathetic measurements have uncovered an unexpected, clinically relevant result: excess parasympathetic responses to sympathetic challenge.

    2003 EEG and Clinical Neural Science Abstract II
    Ansar's ANS monitoring indicated a significant correlation between severity of autonomic dysfunction and time of exposure to industrial solvents.

    2003 Environmental Medicine Abstract I
    Ansar's ANS monitoring permits early recognition of seemingly inconsequential symptoms. Early recognition may thwart more serious diseases from occurring. Early recognition and treatment improves ANS health and can lead to improved patient outcomes.

    2003 Environmental Medicine Abstract II
    Ansar's ANS monitoring scientifically assesses the combined effects of sleep, exercise, nutrition, medications and supplements, and environmental factors on patient well-being and outcomes

    2004 American Academy of Neurology Abstract
    Ansar's ANS monitoring is 85% more sensitive in determining the onset of autonomic (small fiber) neuropathy than nerve conduction velocity studies. Young patients with confirmed AN (early AN - patients without end organ damage), including Parkinson's patients, alcoholics, diabetics, multiple sclerosis patients, and non-vestibular dizzy patients, were identified more reliably, enabling earlier, more aggressive interventions to preserve ANS integrity.

    2004 Diabetes Technology Abstract
    Ansar's ANS monitoring can diagnostically differentiate between acute (reversible, functional) ANS dysfunction and chronic (structural, anatomic) ANS dysfunction.

     
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