BEAMMED INC.

FDA Registration(s)#

GUDID#

• BeamMed - """Tetrax balance assessment is used to quantitatively detect changes in postural responses that have been shown to be indicative of the presence of a disturbance or pathology that affects balance and posture. It is used for the assessment of fall risk and as an aid in the diagnosis of a number of conditions that affect balance. The device designed in tour different modifications: Tetrax system contains platform and railing and Tetrax Free Plates that includes only 2 balance plates. The Tetrax provides valuable information concerning the functioning of neuro-physiological centers of postural control. This information assists the physician in confirming clinical impressions or suspicions. It helps to focus tests prescribed for the patient, and, more important, limits unnecessary tests, especially in cases of dizziness, vertigo, tiredness, and manyother balance disorders or pathologies. The Tetrax system offers the possibility of evaluating the effects of therapeutic interventions in such cases. The system is capable of providing the physician with a comprehensive assessment of postural control and therefore may be used to assess accident proneness due to fatigue, stress, and/or intoxication. The Tetrax system provides valuable information on the effectiveness of prosthetic devices, including prostheses, splints, corsets, etc.Tetrax has wide application in the field of child psychology and developmental pediatrics and can be used in children for detecting neuro-physiological sources of insufficient school readiness, learning disabilities, dyslexia, Attention Deficit Disorders (ADD), etc.The Tetrax device includes a balance platform with a USB connector and software supplied on a CD for installation on a standard PC or an Omnisense device. The Tetrax balance platform is a platform that includes four separate plates. The subject stands on the platform, with each heel and toe-part on one of the four plates, guided by a foot-shaped sketch on each of the plates. Within"

  BEAMMED LTD

  2017-01-25

• BeamMed - """Omnisense 7000:The Sunlight Omnisense Ultrasound Bone Sonometer is a non-invasive ultrasound device capable of measuring bone speed of sound (SOS) at one or more skeletal sites. It is comprised of a Main Unit and small hand held probes, each designed to measure SOS at one or more specific skeletal sites. The basic system is offered with one probe, capable of measuring SOS of the distal one-third radius and the mid-shaft tibia.Reference databases are provided for measurements at each of the skeletal sites.Omnisense measures SOS utilizing a technology based on well established laws of physics applied to the transmission of signals along the bone. The measurements are performed while the subject and the operator are comfortably seated.Results are expressed in meters per second (m/sec), reflecting the upper 95th percentile of the sorted SOS values. Omnisense reports the bone SOS, together with the T-score (units of standard deviations relative to population reference values of healthy young adults), Z-score values (units of standard deviations relative to age and gender matched population reference values), and patient risk assessment, computed using the patient's SOS value and a reference database. For any two measured skeletal sites, Omnisense may report the Osteoporosis, Risk Index (ORI™), which combines the individual results into a single clinical index.No calibration is required. Daily system verification is accomplished using the System Quality Verification (SQV) phantom supplied with the device.Probes:Omnisense is a multiple skeletal sites. The probes designed to support measurement at the following areas:• CM probe - used for bone strength assessment at the radius and tibia• CS probe - used for bone strength assessment at the phalanx• CR probe - used for bone strength assessment at the metatarsalThe probes can be supplied with Omnisense 7000 and/or Omnisense 8000.Omnisense models:S – Adult applicationP – Pediatric application Premier - Premature"

  BEAMMED LTD

  2017-01-25

• BeamMed - """Sunlight MiniOmni:The Sunlight MiniOmni Ultrasound Bone Sonometer is a non-invasive ultrasound device capable of measuring bone speed of sound (SOS) at one or more skeletal sites. Sunlight MiniOmni Ultrasound Bone Sonometer is a modified version of company's well- established Sunlight Omnisense systems*. Sunlight MiniOmni is based on the Sunlight Omnipath™ technology already CE marked and approved by the FDA (PMA). It is comprised of a Main Unit and the same hand held probes as used with other BeamMed's Bone Sonometers, each designed to measure SOS at one or more specific skeletal sites. The basic system is offered with one probe, capable of measuring SOS of the distal one-third radius and the mid-shaft tibia.Reference databases are provided for measurements at each of the skeletal sites, Sunlight MiniOmni measures SOS utilizing a technology based on well- established laws of physics applied to the transmission of signals along the bone. The measurements are performed while the subject and the operator are comfortably seated.Results are expressed in meters per second (m/sec), reflecting the upper 95th percentile of the sorted SOS values. Sunlight MiniOmni reports the bone SOS, together with the Z-score (units of standard deviations relative to age and gender matched population reference values), for adults also as a T-score values (units of standard deviations relative to population reference values of healthy young adults), and patient risk assessment, computed using the patient's SOS value and a reference database. For any two measured skeletal sites, Sunlight No calibration is required. Daily system verification is accomplished using the System Quality Verification (SQV) phantom supplied with the device.Probes:MiniOmni is a multiple skeletal sites. The probes designed to support measurement at the following areas:• CM probes - used for bone strength assessment at the radius and tibia• CS probe - used for bone strength assessment at the phalanx• CR "

  BEAMMED LTD

  2017-01-25