kgm0612
03-28-2007, 05:40 AM
Globes [online] is reporting that NiliMEDIX, a manufacturer of disposable insulin pumps from Israel, has filed a 510k fast-track application for FDA approval to market its devices in the US.
NiliMEDIX develops innovative durable (to be used for several years) and disposable (replaced every 2-3 days) insulin pumps for helping diabetics manage their diabetes.
Insulin pumps deliver insulin the way a healthy pancreas does allowing freedom in daily activities and improving the quality of life of their users.
Moreover, the pumps usually decrease the needed daily amount of insulin by reducing the insulin resistance of the body cells and reduce the number of hypoglycemia and hyperglycemia incidences.
In production of the its pumps, NiliMEDIX is integrating advanced microelectronic technologies. The developed pumps are passive based on Discrete Pressure Compensation (DPC) technology using sensitive pressure and temperature sensors monitored by microprocessors and are implementing MEMS and microinjection technologies that assure high repeatability, safety, accuracy, small dimensions and low production costs.
NiliMEDIX insulin pumps have several unique features over presently available pumps (under development). Among them:
Less malfunctions, as it has no moving parts such as motor, reduction gear etc.
Enlarged Image
Lowest energy consumption (AAA battery).
Low production cost.
Delivers true and even doses at all times.
Unique ability to sensing air bubbles.
Reliable(at real time) occlusion sensing
Infusion set disconnection warning.
Leakage alarm.
Air bubbles are NOT counted as a given dose of insulin
Does not accidentally oversupply insulin.
--------------------------------------------------------------------------------
The disposable pumps allow several additional advantages:
Pre-filled cartridge
Enlarge Image
No infusion sets need to be used.
Reduced end-user costs
No need to change batteries
The company expects a relatively short time to market due to fast track regulatory pathways. The durable and the disposable pumps are expected to be launched during 2008.
NiliMEDIX develops innovative durable (to be used for several years) and disposable (replaced every 2-3 days) insulin pumps for helping diabetics manage their diabetes.
Insulin pumps deliver insulin the way a healthy pancreas does allowing freedom in daily activities and improving the quality of life of their users.
Moreover, the pumps usually decrease the needed daily amount of insulin by reducing the insulin resistance of the body cells and reduce the number of hypoglycemia and hyperglycemia incidences.
In production of the its pumps, NiliMEDIX is integrating advanced microelectronic technologies. The developed pumps are passive based on Discrete Pressure Compensation (DPC) technology using sensitive pressure and temperature sensors monitored by microprocessors and are implementing MEMS and microinjection technologies that assure high repeatability, safety, accuracy, small dimensions and low production costs.
NiliMEDIX insulin pumps have several unique features over presently available pumps (under development). Among them:
Less malfunctions, as it has no moving parts such as motor, reduction gear etc.
Enlarged Image
Lowest energy consumption (AAA battery).
Low production cost.
Delivers true and even doses at all times.
Unique ability to sensing air bubbles.
Reliable(at real time) occlusion sensing
Infusion set disconnection warning.
Leakage alarm.
Air bubbles are NOT counted as a given dose of insulin
Does not accidentally oversupply insulin.
--------------------------------------------------------------------------------
The disposable pumps allow several additional advantages:
Pre-filled cartridge
Enlarge Image
No infusion sets need to be used.
Reduced end-user costs
No need to change batteries
The company expects a relatively short time to market due to fast track regulatory pathways. The durable and the disposable pumps are expected to be launched during 2008.