InnerCool launches new web site
Cardium Therapeutics (San Diego) and its operating unit InnerCool Therapies reported the launch of InnerCool's newly redesigned web site at www.innercool.com. The updated and expanded web site highlights InnerCool's new RapidBlue endovascular temperature modulation system, its CoolBlue surface system, and CoolConnect Adapters to allow CoolBlue surface pads to be used with other hypothermia consoles.
The RapidBlue system includes a programmable console with an enhanced user-friendly interface and touch panel screen and powers the low profile flexible Accutrol catheter to quickly modulate patient temperature at cooling rates of 4-5 C per hour or warming rates of 2 - to 3 C per hour.
The Accutrol catheter, which has a flexible metallic temperature control element and a built-in temperature feedback sensor to provide fast and precise patient temperature control, can accurately measure core body temperature within 0.1 C. Its software control algorithm provides automated and precise body temperature control, eliminating the use of peripheral temperature probes which are generally slow in responding to core temperature changes.
Exact in good standing with Nasdaq Capital
Exact Sciences (Marlborough, Massachusetts) said that it received a determination from the Nasdaq Stock Market indicating that the company has evidenced full compliance with all requirements for continued listing on the Nasdaq Capital Market. As a result, the company's securities will continue to trade on the Nasdaq Capital Market.
New glucose monitoring study published
Clinical and Laboratory Standards Institute (CLSI; Wayne Pennsylvania) recently published Performance Metrics for Continuous Interstitial Glucose Monitoring; Approved Guideline (POCT05-A), which provides recommendations for methods for determining analytical and clinical metrics of continuous interstitial glucose monitors (CGMs).
CGMs are medical devices that measure glucose in the interstitial fluid just under the skin. CGM offer patients the potential of monitoring their glucose and managing insulin levels without repeated fingersticks. CGM technology has the potential to revolutionize diabetes management by providing real-time information not only about current glucose level, but also about time-dependent characteristics of glucose fluctuation, in particular about the short-term or instantaneous glucose rate and direction of change.
CLSI is a global, nonprofit, membership-based organization specializing in standards and guidelines for the healthcare and medical testing community.
Report says adhesion barrier market to grow
According to Millennium Research Group's (MRG's; Waltham, Massachusetts) US Markets for Surgical Hemostats, Internal Tissue Sealants, and Adhesion Barriers 2009 report, growing surgeon interest in adhesion barriers, combined with numerous upcoming product launches, will fuel revenues in the US adhesion barrier market. Exceeding $550 million by 2013, the adhesion barrier market will experience a compound annual growth rate of almost 25% over the next five years.
It is estimated that the cost of treating adhesiolysis (the surgical removal of adhesions) in the US is over $2 billion annually. Due in part to the narrow range of approved indications for currently available products, the US adhesion barrier market remains underpenetrated; however, interest in these products is expanding rapidly as hospitals and surgeons realize the many benefits of using an adhesion barrier in surgical procedures. This interest will prompt a growing number of competitors to enter the US adhesion barrier market in the coming years.
Millennium Research Group is a provider of strategic information to the health care sector.
Tibion gets California manufacturing license
Tibion (Moffett Field, California) said it has received a license from the State of California Food & Drug Branch (FDB) to manufacture medical devices. Tibion has developed the PowerKnee, a wearable bionic device for the leg which actively and transparently supplements muscle strength.
To achieve licensure, Tibion demonstrated compliance with the federal Good Manufacturing Practice (GMP)/Quality System Regulation (QSR) as part of a rigorous audit conducted by an inspector from the FDB. This regulation governs the requirements for a comprehensive management system for the design and manufacture of medical devices. The FDB works in partnership with the federal Food and Drug Administration (FDA) to regulate medical devices in California.
Crothall Services completes CIMS certification
Crothall Services Group (Wayne, Pennsylvania) reported the completion of requirements for the Cleaning Industry Management Standard (CIMS) certification program on Jan. 26. Crothall says this makes it the first company dedicated exclusively to healthcare support services to receive certification from ISSA, the worldwide cleaning industry association.
To become certified, an organization must demonstrate its compliance with the requirements described in the five sections of management best practices that make up the Standard. An independent, accredited assessor conducts an on-site review of the applicant's systems, processes, and documentation to ensure compliance. The organization has to meet 100% of the mandatory elements and 60 percent of the recommended elements per section to achieve certification.
St. Jude investor conference is Feb. 6
St. Jude Medical (St. Paul, Minnesota) will hold its 2009 Investor Conference on Feb. 6, from 8 a.m. 2:30 p.m. EST. This presentation will be webcast by CCBN and can be accessed at St. Jude Medical's web site at www.sjm.com.
The webcast will also be distributed over CCBN's Investor Distribution Network to both institutional and individual investors. Individual investors can listen to the call through CCBN's individual investor center at www.companyboardroom.com or by visiting any of the investor sites in CCBN's Individual Investor Network. Institutional investors can access the call via CCBN's password-protected event management site, StreetEvents (www.streetevents.com).
Oxygen concentrator gets Army compliance
SeQual Technologies (San Diego), a medical equipment manufacturer that makes oxygen systems, said it has received the Airworthiness Release (AWR) from the U.S. Army's Research, Development, and Engineering Command for the Eclipse Oxygen Concentrator 1000A. The certification indicates that the Eclipse Oxygen Concentrator 1000A is in compliance with the U.S. Department of Defense medical device certification criteria and is now certified for use aboard Medevac-60 Blackhawk helicopters.
SeQual says the Eclipse Oxygen Concentrator 1000A offers immediate, robust, dependable oxygen delivery and supports individual patients far forward on the battlefield and during medial evacuation missions. It is a small, lightweight point-of-use generator that can be moved with the patient which produces 93% 3 medical grade oxygen and powered by AC/DC or battery. The system eliminates the safety hazards of pressurized oxygen and logistical burden of continual resupply of oxygen cylinders.