MMT 2009 Volume: 13 Issue: 8 (December)
Quick-Med Technologies announced that the Food and Drug Administration has issued guidance to support the classification of the company’s Novel Intrinsically MicroBonded Utility Substrate (NIMBUS) barrier gauze wound dressings as Class II medical devices. This novel wound dressing received its initial market clearance February 25, 2009, via FDA’s De Novo review process, a special clearance program for medical devices that are found to be “not substantially equivalent” to any predicate device.
The newly issued guidance pertains to a wound dressing with permanently bound cationic biocide polyDADMAC, a key component of the NIMBUS technology and one of the molecular entities covered in nine Quick-Med U.S. patents and patents pending, and in 24 foreign counterparts. The guidance document specifies only the cationic biocide polyDADMAC; dressings with other cationic biocides are not within the scope of this guidance.
J. Lodd Greeno:
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High-Resolution Microdisplays
Emagin began a two-year, $6 million program to develop an ultra-high-resolution organic light emitting diode (OLED) microdisplay with 1920- by-1200 triad color pixels for use with advanced medical training systems. Overseen by the U.S. Army Medical Research and Materiel Command’s Telemedicine and Advanced Technology Research Center, the Widescreen Ultra Extended Graphics Array (WUXGA) microdisplay will measure less than 1 inch diagonally but have over 7 million pixels at a 9.6 micron color pitch, the company said in a press release.
Participants in the program also include Rockwell Collins and Columbia University, Emagin said. Emagin’s OLED microdisplays are currently meeting military specifications across diverse applications, including IR night vision and tactical situational awareness HMDs, in addition to being integrated into commercial devices such as thermal video cameras and video gaming systems.
Biological Agent Detector
Universal Detection Technology, a developer of early-warning monitoring technologies and counter-terrorism training programs to protect people from bioterrorism and other infectious health threats, announced that it will showcase the latest developments in bio-weapons detection technology, including the TS-10-5-agent biodetection kit, at Milipol Paris 2009.
Universal Detection Technology’s kits are handheld assays designed to detect and identify up to five separate threats using one sample in a single device. The kits equip first responders with an effective tool for the rapid onsite detection of up to five biological warfare agents: anthrax, ricin, botulinum toxin, Y. pestis (plague) and Staphylococcal Enterotoxin B (SEB). Detection time is under three minutes, the company said.
Amir Ettehadieh:
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Rapid Virus Detection
VeriChip, a provider of radio frequency identification (RFID) systems, announced it completed its acquisition of Steel Vault, a provider of identity security products and services. The newly merged company, to be called PositiveID, will focus on a rapid virus detection system for the H1N1 virus and other forms of pandemic viruses, and an in-vivo glucosesensing RFID microchip, both of which are currently under development with partner Receptors.
Allison Tomek:
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CTE Research
A new program involving San Diego-based Aethlon Medical, Boston University School of Medicine’s Center for the Study of Traumatic Encephalopathy (CSTE) and the Sports Legacy Institute are studying the brain tissue of professional athletes with chronic traumatic encephalopathy (CTE). The research goal of the program, which is of interest to military researchers studying the effects of head trauma as a result of improvised explosive devices and other current combat perils, is “to discover common biomarkers, including dormant viruses, that might lead to a diagnostic product able to identify athletes with an increased susceptibility to suffer from CTE,” according to a press release from Aethlon. Aethlon develops diagnostic and therapeutic devices for infectious diseases and cancer.
Biomonitoring Device
Annapolis, Md.-based Zephyr Technology Inc. plans to exhibit its Physiological Status Monitoring (PSM) system at the 2009 SOMA conference. This commercially available system provides biomonitoring on the battlefield, monitoring vital signs and body movement and transmitting this information wirelessly to enable assistance and decisions to be made remotely. An individual’s status is displayed as “red,” “orange” or “green” on a command monitor, PDA or wrist screen. Zephyr began work in 2007 with DoD’s Technical Support Working Group (TSWG) to apply Zephyr’s patent-pending technology to the military operating environment. Zephyr said the system is now interoperable with encrypted military radios, including Thales MBITR, JEMS and Motorola.
Steven Small:
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Diagnosing mTBI
Pittsburgh-based Neuro Kinetics is currently working with the U.S. Army Aeromedical Research Laboratory at Fort Rucker, Ala., to test a system it developed for diagnosing and treating mild traumatic brain injuries (mTBI), of which some 20 percent of soldiers returning from Iraq and Afghanistan are said to suffer, the company said in a press release.
Neuro Kinetic’s I-Portal Neuro-Otologic Test Center (NOTC) is being tested at the Tripler Army Medical Center in Hawaii; the Traumatic Brain Injury Warrior Resilience and Recovery Center at Fort Campbell, Ken.; and the Walter Reed Army Medical Center in Washington, D.C. The project is expected to run until July 2010.
“Research suggests that the oculometric measurements included in the I-Portal NOTC’s battery of tests can provide effective neuro-physiologic and vestibular-auditory evaluations for mTBI, and that in turn can improve early screening and treatment,” NKI President and CEO J. Howison Schroeder said in the release.
CBRN Mask
Marines and sailors with Marine Wing Support Squadron 172, Marine Wing Support Group 17, 1st Marine Aircraft Wing, III Marine Expeditionary Force, experienced their last gas chamber training with the M40A1 mask at Marine Corps Air Station Futenma November 4. In the classroom, Marines and sailors received detailed instruction on chemical welfare and its evolution in military history. They also learned medical care to be administered in case of an attack. Then, they went to the gas chamber.
The dates the new M50 Joint Service General Purpose (JSGP) masks will be issued vary for different units and commands, Coulter said. MWSS-172 is slated to trade in its M40A1 for M50 masks later this month.
The M50 JSGP mask weighs less than the M40A1 and has a larger field of vision. The new mask also features 24 hours of chemical and biological protection, breathing resistance reduction and a service life indicator. Complementing the M50 mask, new techniques are expected to be incorporated in the near future.
NBC Protection
The Oman Sultanate’s Ministry of Defence recently ordered two of Kärcher Futuretech’s Decontain 3000 GDS systems, which will be transported on MAN carrier vehicles. The systems are used for the simultaneous decontamination of vehicles, persons, equipment and road sectionsn. In addition, Oman’s Armed Forces will dispose of a defense stock of decontamination agents using the company’s RDS 2000 decontamination agent, BDS 2000 biological decontaminant agent system and the non-aqueous GDS 2000 decontamination agent.
Kay Kabermaier:
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