The First FDA Cleared Concussion-Specific Medical Device

ImPACT, the most widely-used and most scientifically-validated computerized neurocognitive concussion management tool available, is the first medical device of its kind to receive U.S. Food and Drug Administration (FDA) de novo clearance. FDA clearance has been granted under Computerized Cognitive Assessment Aid for Concussion, a new category for a device that uses an individual’s score(s) on a battery of cognitive tasks to provide an indication of the current level of cognitive function in response to concussion. FDA de novo clearance signifies ImPACT has met the FDA’s premarket requirements to demonstrate accuracy, validity, and reliability for concussion management and specifically states that ImPACT will “aid in the assessment and management of concussion.”



“ImPACT’s FDA clearance is a huge step forward for the industry, for athletes and others who are at-risk of concussion-related injuries, as well as for licensed, trained medical professionals everywhere,” said Michael Wahlster, Chief Executive Officer of ImPACT Applications. “ImPACT Applications has a proven commitment to science, research, and innovation. That is why a global network of hospitals, clinics, youth sports organizations, and professional athletes utilize and trust ImPACT.”

ImPACT is the only concussion-specific tool with more than 14 years of independent evaluation and scientific validation. In addition, over 250 peer-reviewed articles, of which half were independently conducted clinical research studies, have built ImPACT’s foundation of trust and value. By achieving FDA clearance in a new category, ImPACT Applications continues to fulfill its role as a pioneer in concussion management by providing customers the safest and most effective concussion management tools on the market.

FDA clearance comes at a time when concussion awareness is growing rapidly. The FDA’s clearance is evidence that ImPACT is an effective tool that adds another level of accountability to the return-to-activity decisions of health care professionals who use ImPACT as part of their concussion management protocol.

FDA de novo clearance is one of several steps ImPACT Applications is taking to advance the science of concussion management, and ImPACT Applications looks forward to continuing to enhance the knowledge base.

A press release can be found from ImPact Website.

Roche launches innovative Accu-Chek Guide blood glucose monitoring systemGuide blood glucose monitoring system

Roche launches of the Accu-Chek® Guide, the next-generation blood glucose monitoring system. This new system is designed to make everyday blood glucose (BG) monitoring easier with features such as the spill-resistant SmartPack test strip vial, which helps users to remove just one strip at a time and avoid spillage or contamination. The Accu-Chek Guide system also provides for advanced accuracy, which enables reliable diabetes management. “As the global leader in diabetes management we are dedicated to supporting people with diabetes, in thinking less about their daily therapy routines. We are very excited to introduce this innovative system, that simplifies blood glucose monitoring and improves the testing experience,” said Roland Diggelmann, CEO Roche Diagnostics. First markets to launch the new system are Denmark, Switzerland and Australia. Morecountries will follow subsequently starting in early 2017.



The Accu-Chek Guide system enables on-board pattern detection that helps to increase awareness of too high or too low glucose readings as well as Bluetooth Low Energy connectivity to the Accu-Chek Connect diabetes management solution via a mobile app. This cloud-based solution guarantees a secure online data exchange and automatic data logging. People with diabetes, caregivers, and healthcare providers can share diabetes information virtually anywhere for timely advice and remote monitoring. Such telemedicine solutions can help people with diabetes and their caregivers manage diabetes more efficiently and give them peace of mind and a feeling of relief. Hence, 97% of 197 participants in a recently published study from France and the US agreed that the system was very easy to use and offers a better testing experience.

The Accu-Chek Guide system not only fulfills current accuracy standards but delivers even tighter 10/10 accuracy for more reliable results3. Consistently accurate measurements are essential for reliable BG monitoring and deriving the correct therapy decisions. Large deviations of the measured BG values from the true glucose levels can result in higher HbA1c levels, glycemic excursions and markedly increased rates of hypoglycemic events, as a recently published retrospective study revealed. In addition, studies have demonstrated that only about half of the BG meters evaluated meet the minimum accuracy requirements as defined by the ISO 15197:2013/EN ISO 15197:2015 Standard.

A press release can be found from Roche Website.

Masimo continuous respiration rate Monitor CE approved

Masimo announced the CE Marking of RAS-45, a single-use adult and pediatric acoustic respiration sensor for rainbow Acoustic Monitoring® (RAM™) of respiration rate (RRa®).



Continuous monitoring of respiration rate is especially important for post-surgical patients receiving patient-controlled analgesia for pain management. The Anesthesia Patient Safety Foundation (APSF) and The Joint Commission recommend continuous oxygenation and ventilation monitoring for all patients receiving opioid-based pain medications.1,2 RAM noninvasively and continuously measures respiration rate using an innovative adhesive sensor with an integrated acoustic transducer, such as Masimo’s RAS-125c and now RAS-45, that is applied to the patient’s neck. Using acoustic signal processing that leverages Masimo’s breakthrough Signal Extraction Technology (SET®), the respiratory signal is separated and processed to display continuous acoustic respiration rate (RRa). RRa has been shown to be accurate, easy-to-use, and reliable, and to enhance patient compliance.RRa may facilitate earlier detection of respiratory compromise and patient distress, offering a breakthrough in patient safety for post-surgical patients and for procedures requiring conscious sedation.



RAS-45 is designed to facilitate placement on and improve attachment to the neck, but with a smaller adhesive profile than the RAS-125c. It is flexible and uses a transparent adhesive. Like the RAS-125c, it operates with Masimo MX technology boards to measure RRa and display the acoustic respiration wave form. RAS-45 maintains the same performance parameters, range, and accuracy specifications as RAS-125c. Both sensors are for patients who weigh more than 10 kg.

Joe Kiani, Founder and CEO of Masimo, commented, “RAM harnesses the power of our breakthrough signal processing technology, using Masimo SET® and rainbow® technologies, and applies those achievements to a respiratory measurement derived from the sound of breathing. Studies have found that RAM RRa is more sensitive to detecting respiratory pause5 and yet easier for clinicians and patients to use.

A press release can be found from Masimo Website.

New sheath provides exceptional access to challenging anatomies and branch vessels

W. L. Gore & Associates, Inc. announced the commercial availability of the GORE® DrySeal Flex Introducer Sheath, after recently gaining clearance for use by regulatory bodies in the U.S., Europe, Canada, and Australia. The device is designed with a distinct combination of enhanced flexibility, kink resistance, and a hydrophilic coating to facilitate access to challenging anatomies and branch vessels, such as the common iliac arteries, during endovascular repair procedures.



The 12 Fr x 45 cm sheath configuration is engineered specifically for use with the GORE® EXCLUDER® Iliac Branch Endoprosthesis (IBE), the only device indicated in the U.S. for endovascular repair (EVAR) of common iliac artery aneurysms or aortoiliac aneurysms. An EVAR often requires multiple wires and catheters be transferred into the vessel via an introducer sheath, which can lead to blood loss through the sheath valve. The sheath’s exclusive DrySeal valve was designed to minimize blood loss, enabling the introduction of multiple devices with proven hemostasis control.

“Nearly a third of patients being considered for EVAR have an aneurysm that extends to the iliac artery. The IBE is a trusted solution in such cases, but previously no introducer sheaths designed for use with this device existed,” said Mr. Marcus Brooks, Consultant Vascular Surgeon, North Bristol NHS Trust. “With the GORE DrySeal Flex Introducer Sheath, I now have a sheath specifically designed for use with the IBE and flexible enough for easy access to the iliac branch vessels.”

The new sheath leverages technology from Gore’s long-trusted GORE® DrySeal Sheath, which features a hydrophilic coating for improved access into vessels. In addition, the GORE DrySeal Flex Introducer Sheath offers an optimized profile and new configurations which include working lengths of 33, 45, and 65 cm.

“The availability of this new sheath provides more options to treat a broader range of patient anatomy,” said Jason T. Lee, MD, Professor of Surgery at Stanford School of Medicine. “The sheath supports my cases from start to finish, offering confidence for a wider range of applications than ever before.”

“By linking our tested GORE DrySeal Flex Introducer Sheath with our endovascular portfolio, we continue to make great strides in advancing patient care,” said Ryan Takeuchi, Gore Aortic Business Leader. “We remain committed to making these innovative devices available to treat more patients globally.”

The GORE DrySeal Flex Introducer Sheath and IBE are available in the U.S., Europe, Canada, and Australia. For more information please visit http://www.goremedical.com/

A virtual brain helps decrypt epilepsy

Researchers at CNRS, INSERM, Aix-Marseille University and AP-HM have just created a virtual brain that can reconstitute the brain of a person affected by epilepsy for the first time. From this work we understand better how the disease works and can also better prepare for surgery.

Worldwide, one percent of the population suffers from epilepsy. The disease affects individuals differently, so personalized diagnosis and treatment are important. Currently we have few ways to understand the pathology’s mechanisms of action, and mainly use visual interpretation of an MRI and electroencephalogram. This is especially difficult because 50% of patients do not present anomalies visible in MRI, so the cause of their epilepsy is unknown.
Researchers have succeeded for the first time in developing a personalized virtual brain, by designing a base “template” and adding individual patient information, such as the specific way the brain’s regions are organized and connected in each individual. Mathematical models that cause cerebral activity can be tested on the virtual brain. In this way, scientists have been able to reproduce the place where epilepsy seizures initiate and how they propagate. This brain therefore has real value in predicting how seizures occur in each patient, which could lead to much more precise diagnosis.

Moreover, 30% of epileptic patients do not respond to drugs, so their only hope remains surgery. This is effective if the surgeon has good indications of where to operate. The virtual brain gives surgeons a virtual “platform.” In this way they can determine where to operate while avoiding invasive procedures, and especially prepare for the operation by testing different surgical possibilities, seeing which would be most effective and what the consequences would be, something that is obviously impossible to do on the patient.
In the long run, the team’s goal is to provide personalized medicine for the brain, by offering virtual, tailored, therapeutic solutions that are specific for each patient. The researchers are currently working on clinical trials to demonstrate the predictive value of their discovery. This technology is also being tested on other pathologies that affect the brain, such as strokes, Alzheimer’s, degenerative neurological diseases, and multiple sclerosis.

A press release can be found on The National Center for Scientific Research (CNRS) website.