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Press release news from the public relations clients of Tiziani Whitmyre, Inc.

Health/Medical Newsfeed

Friday, June 19th, 2015

PathMaker Neurosystems Inc. Named as Healthcare Semi-Finalist in Hello Tomorrow Challenge Global Start-Up Competition

BOSTON, June 19, 2015 – PathMaker Neurosystems Inc. (“PathMaker”), a clinical-stage neuromodulation company developing novel non-invasive systems for the treatment of neuromotor disorders, announced that it was named as one of five healthcare semi-finalists selected to advance to the finale of the “Hello Tomorrow” Challenge, the global start-up competition, being held June 24-26.

Hello Tomorrow” is a global competition covering all major fields of technology that promotes the most innovative breakthrough technologies being developed by entrepreneurs who are taking on the most important challenges in the world today. This year, there were 3,600 proposal submitted from 90 countries.

PathMaker Neurosystems was selected as one of only five healthcare semi-finalists selected to present next week in the competition finale. “The PathMaker team is tremendously excited and honored to be invited to present as a semi-finalist at the Hello Tomorrow Challenge,” said Nader Yaghoubi, M.D., Ph.D., President and Chief Executive Officer of PathMaker. “Our technology prototypes have already changed the lives of numerous patients with neuromotor dysfunction.  We are committed to rapidly moving forward our pioneering non-invasive technology so that we can treat a global backlog of patients waiting for a therapy that can help them.”

PathMaker Neurosystems Inc. was founded to commercialize recent breakthrough advances in the development and clinical application of trans-spinal direct current stimulation (tsDCS) for patients with neuromotor disorders. tsDCS is a novel modality for non-invasive neuromodulation that has only emerged within the last five years, being driven by fundamentally new understandings of spinal circuit biology made by our Company’s scientific advisors and their clinical work in treating patients with paralysis, muscle weakness and muscle tone disorders.  More than 27 million patients in the US and Europe suffer disabilities due to stroke, cerebral palsy, multiple sclerosis, spinal cord injury, traumatic brain injury, Parkinson’s disease and other neurological disorders, and the breakthrough non-invasive technology that PathMaker is developing promises to open up entirely new methods of treating these patients.

About PathMaker Neurosystems Inc.
PathMaker Neurosystems Inc. is a clinical-stage neuromodulation company founded to commercialize recent breakthrough advances in the development and clinical application of trans-spinal direct current stimulation (tsDCS) for patients with neuromotor disorders. More than 27 million patients in the US and Europe suffer disabilities due to stroke, cerebral palsy, multiple sclerosis, spinal cord injury, traumatic brain injury, Parkinson’s disease and other neurological disorders, and the breakthrough non-invasive technology that PathMaker is developing promises to open up entirely new methods of treating these patients.  For more information, please visit

Thursday, January 15th, 2015

Whitepaper Shows Hospitals How to Investigate, Resolve Fire Wall Breaches to Advance Life Safety in Healthcare

Needham, Mass. — January 15, 2015 — An award-winning program that rapidly identified and resolved fire and life safety deficiencies during construction and renovation projects at Brigham and Women’s Hospital (BWH) is detailed in a new whitepaper from EH&E, a leading provider of environmental and engineering consulting services. The paper is available to download at

Construction, renovation, maintenance and tele/data upgrades are a constant in hospitals across the US. The complexity of these projects and the pace of the schedule can lead to unexpected compromises in fire barrier integrity. To address this broadly recognized challenge, BWH partnered with EH&E to develop a new approach to fire stopping and life safety management.

The resulting program set a “new benchmark” and established “a model of best practices” — winning the 2014 IFMA (International Facility Management Association) Boston Excellence Award for Best Practices in Sustainability. It is now detailed in the new whitepaper,  Ensuring Fire Barrier Integrity for Patients, Staff and First Responders: Continuous Compliance Through Information Management — presenting each step of the program in case study format.

Topics include: Root Cause Investigation of Fire Barrier Integrity Challenges, Financial Modeling of Fire Barrier Deficiencies, Implementation of an Information Management Solution and Results, and Successful Implementation of Construction Life Safety Information Management (C-LIM) Process.

Download the paper, “Ensuring Fire Barrier Integrity for Patients, Staff and First Responders: Continuous Compliance Through Information Management,” at

About EH&E

EH&E a leading provider of environmental and engineering consulting services, guarantees that its application of science and engineering best practices will deliver measurable, quantifiable benefits in all aspects of the built environment. EH&E’s focus on evidence-based decision making and advanced capabilities in analytics and technology innovation help its clients achieve and quantify optimal performance from their people and assets. For more information, visit the EH&E website at

Friday, December 12th, 2014

Rapid Bacterial Assay Enables Compliance with FDA Guidance for Enhancing Platelet Transfusion Safety

BacTX-mdBOSTON, MASSACHUSETTS, U.S.A. — December 12, 2014 — Immunetics Inc., a leading clinical test provider, announced today that its newly commercialized BacTx® Rapid Assay will enable blood banks and transfusion centers to comply with the U.S. Food and Drug Administration’s (FDA) recently released draft guidance for the testing of platelets for bacterial contamination to enhance transfusion safety.

In its draft guidance for industry (December 2014), the FDA cited the risks of bacterial contamination of platelets and the critical need for means to mitigate these risks.  In particular, FDA recommended that all pooled whole blood-derived platelets be subjected to rapid bacterial testing prior to transfusion. The agency also expressed concern over the safety of 4- to 5-day-old platelets – noting that the majority of sepsis incidents and fatalities were associated with these higher-risk units. Following recommendations of its Blood Products Advisory Committee, FDA suggested that testing of 4- to 5-day old units with a rapid, point-of-issue assay would be an effective way to detect and interdict contaminated platelet units.

The BacTx test from Immunetics is cleared by the FDA for the rapid testing of platelets for bacterial contamination prior to transfusion. It relies on a unique, patented detection chemistry that is specific for bacteria.

“The FDA has acknowledged the effectiveness of rapid testing in protecting patients from transfusion of contaminated platelets. The BacTx system is designed to detect the lower levels of bacteria of all types that can proliferate over time and may escape detection by other testing methods,” said John Yonkin, chief executive officer of Immunetics.

To facilitate compliance with FDA’s recent guidance, the BacTx test is designed for easy integration with lab workflows. “We realized that rapid bacterial testing for platelets would be a new activity for many labs, so assisting them with easy workflow and data management became a key goal of the BacTx system,” Yonkin said. “We had to ensure that BacTx delivered a highly sensitive test that was truly manageable within a demanding laboratory work environment.”

The BacTx test provides assay results and interpretation within 30 minutes. Test monitoring and interpretation rely on an automated random access analyzer and software with bar code scanner input that enable data entry, tracking, traceability and analysis for up to 8 samples per run.

The BacTx system meets AABB standard and is cleared for quality-control testing of leukocyte-reduced apheresis platelets (LRAP) within 24 hours of transfusion, and pools of up to six units of leukocyte-reduced whole-blood derived platelets that are pooled within 4 hours of transfusion.

The FDA draft guidance also described a future pathway to extending platelet dating to 7 days from the current 5-day standard, contingent upon the use of an approved rapid test late in the storage period. Such an extension in dating will allow blood banks and transfusion centers to use platelets that would otherwise be discarded solely due to outdating, saving money and avoiding shortfalls in platelet inventory.“Immunetics is committed to supporting this initiative with the BacTx test,” said Yonkin.

For more information on the BacTx Rapid Assay, visit the Immunetics Website at or contact Immunetics at 1-617-896-9100 or toll-free at 1-800-227-4765.

About Immunetics

Immunetics, Inc. offers state-of-the-art assay technology for infectious disease diagnosis and blood screening, and for more than 10 years, has been a leading innovator of tests for bacterial, viral, and parasitic diseases. The company produces and markets a range of infectious disease assay kits and instruments. The company has issued patents on its BacTx test for bacterial contamination of platelets. It has developed and markets other FDA-cleared products, including a test for Lyme disease, and is actively working on new tests for Babesiosis and Chagas disease — both of which are emerging risks to the blood supply. Immunetics is headquartered in Boston, Massachusetts. The company’s mission is to deliver better cost-efficient care through more accurate diagnosis. For more information, visit the Immunetics website at

BacTx® is a registered trademark of Immunetics, Inc.BacTX-md

Monday, December 1st, 2014

DECTRIS Ltd. Introduces Hybrid Photon Counting (HPC) Detection for use in Medical Imaging Equipment

Phase contrast image - fusion of absorption and dark field images. Thomas Thuering et al, PSI, Switzerland.

Phase contrast image – fusion of absorption and dark field images. Thomas Thuering et al, PSI, Switzerland.

Chicago (USA), December, 1, 2014:DECTRIS Ltd. is introducing its hybrid photon counting (HPC) detection technology to enable the next generation of medical imaging equipment — and transform everything from mammography to computerized tomography (CT).

Until now, X-ray detection in medical imaging has mainly relied on the indirect methods utilized by traditional integrating detectors lacking energy discrimination. Unlike these less sensitive devices, HPC detectors provide direct sensing of every single photon in an X-ray — made possible by innovations including optimized solid-state sensors and CMOS readout ASICs using hybrid pixel technology.

Given these properties alone, HPC should far surpass the performance of older technologies in terms of dose and resolution. Paired with advanced new imaging equipment and analysis algorithms, the additional spectral information will open up a new dimension in specificity.

“Designers and radiologists in the medical imaging world have been anticipating the arrival of detection techniques based on Hybrid Photon Counting — it shall allow best possible image quality and the highest sensitivity at the lowest dose.”, said Willi A. Kalender, Professor at the Institute for Medical Physics in Erlangen, Germany.

[Visit DECTRIS Ltd. at the RSNA 2014 Annual Meeting,
in North Hall B: 8047.]

DECTRIS is the world’s acknowledged leader in HPC detection, having produced more than 6,000 HPC detector modules to date — far more than any other source — for a variety of applications in science and industry. DECTRIS’ unique, pioneering HPC technology delivers:

  • Very high resolution — achieving the best signal-to-noise ratio via a noise-free signal with no dark current
  • Very high data rates — via dedicated ASIC and electronic design
  • Exclusive spectral information — via energy analysis, for simple color imaging
  • Highest (almost perfect) spatial resolution — via direct detection, without scintillators, fiber optics, etc.

As the leader in HPC technology, DECTRIS is ready to work with medical imaging OEMs to help realize such new possibilities as:

  • Highlighting microcalcification in breast tissue — with color images produced by new capabilities for energy analysis
  • Highlighting contrast agents such as iodine in mammography

In addition, tissue differentiation is improved for better-informed diagnosis — with phase-contrast imaging used in combination with HPC.

For more information, visit DECTRIS Ltd. at RSNA 2014 in North Hall B: 8047. Or visit the DECTRIS website at or call 0041.56.500.2180


As the technology leader in X-ray detection, DECTRIS aims to continuously improve measurement quality to enable new findings and innovative results in science, industry, and medicine. DECTRIS X-ray detectors make optimum use of the company’s pioneering hybrid photon counting (HPC) technology. It has transformed basic research at synchrotron light sources, as well as in laboratory and industrial X-ray applications worldwide. For more information, visit or call 0041.56.500.2180

Thursday, November 20th, 2014

New EH&E Inc. Program Improves Fire & Life Safety Compliance During & After Construction at Hospitals

EH&E LogoNeedham, Mass., November 20, 2014 — EH&E, a leading provider of risk management, environmental and engineering consulting services, has introduced a new inspection service that assists hospitals to improve firestopping and life safety compliance during and after construction projects.

Construction, renovation, maintenance, and tele-data upgrades are constant at hospitals. The complexity and pace of these projects can lead to unexpected compromises in firewall barriers — creating both compliance problems and safety issues.

EH&E’s new Firestopping and Life Safety Management program, designed in conjunction with Brigham and Women’s Hospital (BWH), shows hospitals how to cost effectively resolve construction-related compliance deficiencies and set the foundation for maintaining life safety and firewall barrier systems throughout the life of their buildings.

By addressing the root causes of firewall breaches and enabling the proactive identification and resolution of fire and life safety deficiencies during construction, the hospital starts with a safe and compliant building at the time of occupation. The hospital saves costs because rather than inheriting fire safety deficiencies from construction, the responsibility for repairs is placed with the contractor. In addition, the program’s “continuous compliance” focus ensures that proper procedures will be followed during ongoing maintenance and future renovations. Field inspectors utilize mobile devices to note conditions and provide photographic documentation that is instantly uploaded to a secure website for real-time notification to the contractors followed by auto-tracking of resolution, acceptance and record keeping.

At BWH, program results included greater than 96% compliance with The Joint Commission, and an estimated savings of more than $1 per square foot of floor area through the repair of firewall deficiencies prior to occupancy.

This summer, the program won the 2014 IFMA Boston Excellence Award for Best Practices in Sustainability, honored for setting “a new benchmark” and establishing “a model of best practices.”

For more information on EH&E’s new Firestopping and Life Safety Management program, or to download a case study detailing the BWH project, visit

About EH&E

EH&E ( has provided an extensive range of risk management, environmental and engineering consulting services for over 25 years. Our team consists of more than 60 experts with an outstanding record of providing business-focused solutions for issues that affect the built environment. Our focus on “evidence-based decision making” and advanced capabilities in analytics and technology innovation enables clientsto achieve and quantify optimal performance from their people and assets. EH&E is the partner of choice for reduced organizational risk, improved business outcomes, faster time to problem resolution and greater stakeholder satisfaction.

Wednesday, November 12th, 2014

Available Time to Train Staff, Certifications to Ship Hazardous Materials are Top Challenges Facing Hospitals in Ebola Preparedness, States EH&E Survey

Needham, Mass. — Nov. 12, 2014 — The lack of available time to train staff, and uncertainties about certifications to ship infectious substances, are the top challenges facing hospitals undertaking Ebola preparedness and safety precautions, according to a recently conducted survey by EH&E, Inc., a leading provider of environmental and engineering consulting services.

“Nearly half (48%) of the hospitals responding to the survey stated that ‘available time for patient care staff’ was the most important limitation in providing hands-on Ebola virus disease training to clinical staff, including hands-on PPE donning/doffing procedures,” according to Bryan Connors, MS, CIH, Healthcare Practice Director, EH&E.

Another 20% cited money or lack of qualified staff and internal resources to support training as their key limitation.

EH&E surveyed hospital environmental health and safety (EHS) managers, risk managers, and facilities mangers in 41 U.S. hospitals. The “EH&E Hospital Ebola Preparedness Surveyfocused on issues relating to personal protective equipment (PPE) training, Ebola-specific training, and hazardous waste management. The survey was conducted in late October.

“EH&E recommends selecting a small number of staff to be highly trained in Ebola preparedness and safety precautions. This group may include a select number of nurses, physicians, respiratory therapists, ‘safety monitors,’ and environmental services staff to participate in initial and periodic retraining sessions, including PPE donning and doffing procedures,” said Bryan Connors, MS, CIH, Senior Scientist and Healthcare Division Practice Leader, EH&E, Inc.

“The ‘safety monitor’ role is critical to staff safety, which works like a ‘Buddy System’ assuring front line clinical staff don and doff PPE appropriately and any safety issues are addressed in real time,” Connors noted.

“Of course, the strategy on how many staff to train will be dependent on many factors, including the type and size of the hospital,” he added.

The survey also identified a potential vulnerability in preparedness as more than half (55%) of hospitals reported not having or not knowing if they have staff trained to ship Category A Infectious Substances per IATA and DOT — such as patient specimens being sent for Ebola diagnosis or that are confirmed positive for Ebola.

“Workflow planning and procedures for Category A Infectious Substances shipments must be in place well in advance of their need,” said Connors. “This type of training can take upwards of eight hours to complete and must be properly documented. In practice, ‘on demand’ training is simply not an option.”

Overall, an overwhelming majority of hospitals reported meeting (76%) or exceeding (12%) CDC guidelines, with 12% replying they had not yet met requirements.

Nearly two-thirds (64%) of hospitals in the survey reported that they are actively conducting Ebola training, including specific PPE training. The reminder had either conducted training for other infectious diseases (21%) or training in Ebola preparedness but without training on specific PPE donning and doffing procedures (10%). Just 5% of hospitals reported not conducting Ebola specific training to date — at least as of October 21.

“It is highly likely that while training has increased in all categories since the survey was taken — the challenges remain as hospitals work to ensure not only the quality of care for patients, but the safety and well-being of caregivers and the public,” Connors noted.

A summary of the survey results, “EH&E Hospital Ebola Preparedness: Survey Results,” is available to download from  Details are available by request by contacting Bryan Connors by phone 1-800-825-5343 or email

About EH&E

EH&E ( has provided an extensive range of environmental and engineering consulting services for over 25 years. Our team consists of more than 60 experts with an outstanding record of providing business-focused solutions for issues that affect the built environment. EH&E has a depth of knowledge and credibility unmatched in the industry and our wealth of readily-accessible information has become a powerful resource for our clients.

Thursday, July 24th, 2014

ASCO Introduces 068 Series Flapper Isolation Valve; Improves Throughput, Reduces Sample Size in Clinical and Analytical Instruments

ASCO 068 Series Flapper Isolation Valve-01FLORHAM PARK, N.J., July 24, 2014 — ASCO Numatics has introduced its 16mm ASCO 068 Series flapper isolation solenoid valve, the first in its class with technology that offers greater throughput, smaller sample sizes, and reduced calibration requirements for clinical and analytical instruments.

“Our new ASCO 068 Series valve’s 20 ms response time and exceptional volume control mean original equipment manufacturers (OEMs) can design instruments with higher productivity, better flushability, and more precise measurements,” said Robert W. Kemple, Jr., executive vice president, sales and marketing – Americas, ASCO Numatics. “End users will benefit from much greater measurement repeatability, smaller sample and reagent requirements, and reduced calibration frequency.”

The ASCO 068 Series valve is ideal for OEMs serving the clinical diagnostic, life science, sterilization, and dental markets.

The valve is designed for use with neutral and aggressive liquids and gases. Its flapper technology allows high pressures to be achieved (up to 116 psi) at large orifice sizes while preventing the fluid contamination that can result from spikes in back pressure inherent in analytical devices. The highly reliable valve has been tested to well over 10 million cycles for extended product life.

The solenoid isolation valve also features:

  • Excellent operating characteristics under vacuum conditions
  • Low pumping effects
  • Self-draining capability and easy-to-flush internal cavity
  • Low heat transfer between control mechanism and media
  • Optional onboard power saver mode

In isolation valves, hermetic separation of the control mechanism and fluid prevents particulate contamination caused by friction of the mechanical components. This ensures maximum purity of the fluids or gases in all isolation applications.

ASCO’s 068 Series valves can be ordered as a turnkey fluid automation solution that includes a manifold with fittings and special connections. “These plug-and-play assemblies provide OEM’s with lower manufacturing costs and faster production cycles,” said Kemple. “Our valves were specifically designed for use in hematology, oncology, chromatography, chemical sterilization, water quality monitoring, DNA sequencing, and liquid-handling equipment applications.”

The 068 Series valves are available through the ASCO Today same-day shipping program and can be ordered through ASCO distributors and sales representatives. For more information, contact ASCO at 800-972-ASCO (2726), by e-mail at, or visit

About ASCO Numatics

ASCO Numatics, an Emerson company, offers comprehensive fluid automation solutions, including fluid control and fluid power products, for a wide range of industry-focused applications. The ASCO Numatics product line in North America consists of more than 50,000 valves, an extensive selection of air preparation equipment, and a full line of actuation products. ASCO products include solenoid pilot valves, angle body piston valves, linear indicators, redundant control systems, and pressure sensors. The Numatics line covers valve manifolds, cylinders, grippers, filters, regulators, and lubricators. For more information about ASCO Numatics products, visit

About Emerson and Emerson Industrial Automation

Emerson ( is a global leader in bringing technology and engineering together to provide innovative solutions for customers in industrial, commercial, and consumer markets around the world. The company is comprised of five business segments: Process Management, Industrial Automation, Network Power, Climate Technologies, and Commercial & Residential Solutions. Sales in fiscal 2013 were $24.7 billion. Emerson Industrial Automation (, a business of Emerson, provides automation and power generation technologies and services to a wide range of industries. With its global capabilities and deep industry expertise, Emerson Industrial Automation is a trusted partner for products and solutions that increase machine performance, efficiency, reliability, and availability. Its industry-leading brands include Appleton®, ASCO®, Branson®, Browning®, Control Techniques, Kop-Flex®, Leroy-Somer®, McGill®, Morse®, Numatics®, O-Z/Gedney, Rollway®, SealMaster®, and System Plast™.


Press Contacts: Don Goncalves, 781-793-9380,

Monday, July 21st, 2014 Offers Free Support Kit to Help Prevent Healthcare Injuries to Caregivers, Patients

photo_kitLehigh Valley, Penn. – July 21, 2014 — The non-profit initiative is offering a free support kit to help prevent healthcare injuries to both caregivers and patients. The kit, which contains useful tools and tips for implementing and sustaining a facility-wide healthcare injuries prevention program, is available to download at

“Healthcare is the largest and fastest-growing sector of the U.S. economy, employing approximately 17 million workers,” said Hans Sigvardsson, president of Handicare US. “Safety must be a priority on all fronts.”

Developed by Handicare US, “the initiative was launched to help stem the growing number of healthcare injuries — the vast majority of which are preventable,” he said. “Our goals is to make ‘no injuries’ a reality for patients, caregivers, and others.”

The “Facility Support Kit” includes handy assessment guides for conducting a facility self-assessment, helpful hints on organizing a team, changing the workplace culture, an early patient mobility guide — and ongoing updates.

The kit is one element of the initiative, Sigvardsson noted. features up-to-date news, educational materials, easy-to-implement tips, and tools and resources to use throughout the workplace. Six critical hazard areas are spotlighted: Patient Handling; Sharps & Sticks; Infections; Slips & Falls; Workplace Violence; and Patient Safety.

Download the “Facility Support Kit” kit at For more information about the initiative on preventing healthcare injuries, visit the website at

About Handicare 

Handicare was founded in 1986 and supplies safe handling and mobility solutions for hospital patients, elderly residents, and physically disabled individuals. Its products include wheelchairs, patient lifts, stairlifts, mobility equipment, bathroom safety products, and personal transfer and automobile adaptation solutions. Handicare products are distributed through a comprehensive network of professional dealers and distributors in 30 countries around the world. The company has subsidiaries in Sweden, Denmark, Germany, the Netherlands, England, Belgium, France, the USA, and Canada. For more information, visit the Handicare website at

About Handicare North America

Handicare NA is headquartered in Allentown, Pennsylvania, and works with over 400 partners in North America to provide Safe Patient Handling, Mobility and Accessibility equipment to people with disabilities, aging and elderly individuals residing at home or in hospitals and nursing homes. With significant growth over the past year, Handicare US is well positioned to assume leadership roles in safe patient handling and improved patient outcomes, both of which are areas of strategic concern for healthcare administrators and caregivers.

The company’s wide range of high-quality products include: Complete easy transfer systems and other patient handling aids, walkers, stairlifts, and bathing and toileting products. In 2012, RoMedic, Inc. (Ephrata, PA) and Sterling Stairlifts (Pocono Mountain, PA) merged to form the Handicare NA and provide solutions and support that allow people to work and live safely and independently.

Tuesday, June 17th, 2014

Fish Embryo Toxicology Testing is Better Alternative for Whole-Effluent Testing, Advises New Whitepaper from Microtest Laboratories

AGAWAM, MASS. – June 17, 2014 – As pharmaceutical, chemical and other manufacturers come under increased scrutiny for their Whole Effluent Toxicity (WET), a new methodology to measure WET — fish embryo toxicity (FET) testing — promises to better determine the potential environmental impact of their products and waste water on the environment.

Developed for environmental and hazard classification applications, FET testing provides many advantages in the testing of pharmaceuticals, chemicals, and pesticides — from their application in the field to their impact in sewage and water runoff from manufacturing facilities.

A new whitepaper titled Fish Embryo Toxicology Testing: The Better Alternative for Whole-Effluent Testing discusses FET testing, how it works, and its benefits. The paper is available for download at from Microtest Laboratories.

FET testing utilizes the embryo of the Zebrafish and exposes it to various compounds to observe potential toxic effects, thus making the test ideal for use in monitoring or investigating environmental cases. FET is an approved OECD (Organization for Economic Co-Operative Development) guideline published in 2013.

Microtest Laboratories is deeply experienced in providing fish embryo toxicity testing, due to the expertise the company developed from creating its own Zebrafish Embryo Toxicity (ZET) test, which it provides as a preliminary screening method in the biocompatibility testing of medical devices and polymers.

For details on the benefits of FET testing, download the whitepaper, “Fish Embryo Toxicology Testing is the better alternative for whole-effluent testing,” from: For information on FET testing services from Microtest Laboratories, visit, or call 1-413-786-1680, or toll-free 1-800-631-1680.

About Microtest Laboratories

Microtest Laboratories is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, USA, the company provides expertise and flexible processes that enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit or call 1-413-786-1680 or toll-free at 1-800-631-1680. Follow Microtest Laboratories on Twitter @MicrotestLabs at

Monday, May 19th, 2014

Fundamentals of Endotoxin Testing for Medical Device Manufacturers are Detailed in New Technical Brief

AGAWAM, MASS. — May 19, 2014 — The fundamentals of endotoxin testing for medical device manufacturers — from definition to assay acceptance criteria —are detailed in new technical brief available from Microtest Laboratories.

Bacterial endotoxins cause fever, septic shock, and other disease symptoms — and thus attract considerable regulatory scrutiny from such organizations as the U.S. Food & Drug Administration (FDA) and the United States Pharmacopeial Convention. Regulations require that devices that contact circulating blood or cerebrospinal fluid, or are used with intraocular products or in vitro fertilization procedures, are required to be endotoxin-free.

The Fundamentals of Endotoxin Testing,” available for download at, is a step-by-step information resource for medical device manufacturers discussing and detailing the:

  • Definition of endotoxins;
  • Various tests used for their detection;
  • Use of depyrogenation and other ways to remove endotoxins;
  • Types of devices that should be tested;
  • Preparation and testing of samples;
  • Options for sampling containers;
  • Acceptance criteria for each of the assays; and
  • Sources of official information, reference, and guidance.

The Fundamentals of Endotoxin Testing” is authored by Steven Richter, Ph.D., said Steven Richter, Ph.D., president and scientific director of Microtest Laboratories — and a former FDA official.

Download the brief from:

The paper is one in a series about testing, manufacturing, and regulatory issues of concern for medical device manufacturers from Microtest Laboratories, a leader in testing services and contract manufacturing for medical devices, pharmaceuticals, and biotechnology.

About Microtest Laboratories

Microtest Laboratories is a leader in testing services and contract manufacturing for medical devices, pharmaceuticals, and biotechnology. It was founded in 1984. The company’s expertise and flexible processes enhance product safety and security, speed time to market, and minimize supply chain disruption. Microtest’s unique single-source capability to provide testing and manufacturing solutions allows the firm to support a full pharmaceutical or medical device product release. The company’s facilities in Agawam, Massachusetts, USA include state-of-the-art aseptic manufacturing areas; analytical chemistry, microbiological, and virological laboratories; Class 100 clean rooms; onsite steam and ethylene oxide sterilization, plus depyrogenation capabilities; purified water systems; and voice/data systems. For more information, visit or call 1-413-786-1680 or toll-free 1-800-631-1680. Follow Microtest Laboratories on Twitter @MicrotestLabs on Facebook at

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