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July 2013.  AME supported partner Remote Diagnostic Technologies Ltd. announces Tempus Pro patient monitor has received FDA clearance and is now CE marked. Learn more.

October 2012.  AME supported partner IntriCon Corporation launches Lumen™ 1000 wireless hearing system at EUHA in Munich, Germany. System includes flexStrem™, voiceStream™ and tvStream™ accessories allowing audio or music, television audio or a companion's voice to be wirelessly broadcasted directly to the hearing aidLearn more.

October 2012. AME supported partner Remote Diagnostic Technologies Limited announces Tempus IC Professional™ patient monitor has been granted a fleet-wide Airworthiness Release (AWR, Aircraft Clearance) from the United States Army. Learn more.

September 2012. AME supported partner M&S Technologies, a leading provider of vision testing systems, releases CustomLink® for the Smart System® Tablet allowing eye care professionals with sub-specialties to easily share the same exam room. Learn more.

May 2012. AME supported partner QRS Diagnostic Corporation Receives FDA 510(k) Market Clearance for Orbit Diagnostic Spirometer.

March 2012.  Upcoming event: 2012 IEEE EMBS Conference. The 34th Annual International Conference of the Engineering in Medicine and Biology Society will take place in San Diego. Learn more.

November 2011.  AME supported partner IntriCon Corporation Receives FDA 510(k) Market Clearance for Sirona Cardiac Diagnostic Monitor. Learn more.

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Advanced Medical Electronics

Advanced Medical Electronics is a product-focused research and development company specializing in medical devices. Our team of experienced scientists and engineers advances designs from initial concept to manufacturing prototype. Our core capabilities include systems design, embedded design, electronics and instrumentation design, wireless design, software development, prototype build, and system testing.

 

Featured FDA Approved Device Designs for License or Purchase

You can endure all the risk, time, and pain of a scratch design, or you can start and finish with a proven solution from us.

Electrocardiograph

Miniature, low power module allows the addition of up to 12 ECG channels to any medical system.  This module is in production and being used in FDA-approved devices currently on the market.   Available for purchase or license at any design level ranging from a complete source level design to manufactured subassemblies. Designed for systems required to meet the following standards:

ANSI/AAMI EC11 Diagnostic Electrocardiographic Devices
ANSI/AAMI EC13 Cardiac Monitors, Heart Rate Meters and Alarms
IEC 60601-2-25 Requirements for the Safety of Electrocardiographs
IEC 60601-2-27 Rqmnts. for the Safety of ECG Monitoring Equipment
 

Features:

Typical 12-lead channels: Leads I, II, III, aVR, aVL, and V1 to V6.
Integrated Muscle Artifact Filter
Isolated Serial Interface
Integrated Patient Isolation to Type CF Applied Part
Defibrillation Protection
Integrated Respiration Waveform Output
Respiration Rate Measurement 2-150 breaths per min
Pulse Rate Detection 30 to 300 beats per min
Pacemaker Pulse Detection
Leads-Off Determination
R-Wave Pulse Trigger Output
 

Manufactured Module:

Size: 3.2" (81 mm) x 2.8" (72 mm)
Nominal Supply Voltage: 5V
Nominal Supply Current: 40 mA
Nominal Power: 200 mW
 

Spirometer

Miniature, low power module allows the addition of diagnostic spirometry to any medical system.  This module is in production and being used in FDA-approved devices currently on the market.   Available for purchase or license at any design level ranging from a complete source level design to manufactured subassemblies. Designed for systems required to meet the following standards:

American Thoracic Society (ATS/ERS) 2005 Standard
British Thoracic Society (BTS) Standard
National Institute for Health and Clinical Excellence (NICE) Guidelines
 

Features:

Range:
Flow: +/-14 liters/second
Volume: 0.5-8.0 liters
Accuracy
Flow:
FEF 25-75: 5% of indication or +/-200 ml/sec, (greater).
PEF: 10% of indication or +/-300 ml/sec, (greater).
Volume:
FVC and FEV1: +/-3% of indication or +/-50 ml, (greater).
MVV: +/-10% of indication or +/-15 L/min, (greater).
Precision
Flow: PEF: +/-5% of indication or 150 ml/sec (greater).
Volume: FVC and FEV1: +/-3% of indication or 50 ml (greater).
Mouthpiece
Used with propreitary single-use pneumotachometers (mouthpieces).
 
Measured Parameters: FVC, FEV0.5, FEV1, FEV6, FEV3, FEV1/FEV6, FEV1/FVC, FEV3/FVC, PEFR, PEFT, FEF25%, FEF50%, FEF75%, FEF25-75%, FEVC, FEV0.5, FIV1, FIV3, FIV1/FIVC, FEV3/FIVC, PIFR, FIF50%, FIF25-75%, FIF.2-1.2, FVC/FIVC, Extrapolated Volume, EOTV, FET, MVV, RR, MTV, SVC.
 

Manufactured Module:

Size: 1" (25 mm) x 2" (51 mm)
Nominal Supply Voltage: 5V