A recent study [1] used a SoundEar3-300 noise warning sign as an isolated intervention to determine whether visualizing noise could produce a sustained noise reduction in adult critical care. It proved a significant noise reduction of 3.9 dB (from 57.4 dB) in median ambient sound levels and saw a significant reduction in peak sound levels (0.7 dB reduction from 66.0 dB). After 4 months with continued use of the SoundEar3-300, researchers found a sustained noise reduction of 3.6 dB compared to baseline recording before introducing the SoundEar. The device acted as an isolated intervention to significantly reduce night-time ambient and peak sound levels, a change that was sustained after a four-month period.
In another study from 2014 [2], a SoundEar device was used as a part of a noise reducing initiative at an operating theatre in Hannover, Germany. This study showed a significant reduction in noise levels in the operating theatre from 63 dB to 59 dB. Moreover, the noise reduction led to a significant reduction in the number of complications after surgery and reduced surgeons’ stress levels by 20%.
1. http://journals.sagepub.com/doi/10.1177/1751143718767773#articleShareContainer
2. https://www.pubfacts.com/detail/24394594/A-noise-reduction-program-in-a-pediatric-operation-theatre-is-associated-with-surgeons-benefits-and- www.soundear.com

Read more

Nevro Corp., a global medical device company specialising in solutions for the treatment of chronic pain, has received the CE mark approval for the Senza® Omnia™ Spinal Cord Stimulation (SCS) system.
“Following a successful launch in the United States late last year, we are excited to now have approval for the Senza Omnia SCS system in Europe,” said D. Keith Grossman, Chairman, CEO and President of Nevro. “As conditions in the marketplace allow, we will be introducing Omnia to physicians throughout Europe. This next-generation SCS system has been developed in close consultation with customers and is designed to provide a comprehensive solution to manage chronic pain. Omnia’s versatility means that patients now have access to a full range of SCS solutions and physicians can have the peace of mind that when they implant the system, they will have the capabilities needed to achieve the best possible outcomes for their patients.”
The Omnia system is a completely new SCS platform and consists of a number of new components. The first is the new Omnia programmer, which will allow physicians to easily offer the widest array of waveforms across the full SCS frequency spectrum, either separately or paired together with HF10. The second element of the system is a redesigned patient remote that is more intuitive for patients to use. The new remote supports greater programming capacity, allowing for the flexibility to expand on the HF10 algorithm by giving physicians the ability to provide additional waveforms. The third component is a redesigned, slimmer patient charger with an improved user interface. Additionally, the system comes with an updated and upgradeable implantable pulse generator. Unlike non-rechargeable systems, the Omnia battery is designed to last over ten years no matter what stimulation profile is used, has conditional full body MRI approval, and will be upgradeable to future waveforms and frequencies.
Other SCS systems on the market are limited to frequencies below 1,200 Hz. In contrast, Omnia delivers the widest range of frequencies of any SCS system, between 2 and 10,000 Hz. In addition to Nevro’s proprietary HF10 waveform, Omnia offers the most waveforms on one device and can be programmed to provide waveforms independently or paired with HF10. The ability to pair frequencies allows Omnia to pair HF10 – the most studied SCS therapy with over 55,000 patients treated across the world – with other waveforms, including traditional, paresthesia-based stimulation, subthreshold 1 kHz therapy or burst waveforms.
For more information, visit: www.nevro.com/Omnia
Read more

The latest addition to the StatStrip line of handheld, hospital meters, the StatStrip Hemoglobin and Hematocrit Meter System (StatStrip Hb/Hct), has gained CE mark certification and is now available in all CE regulated countries. StatStrip Hb/Hct is the only point-of-care (POC) meter to measure hemoglobin and hematocrit for accurate anemia screening and blood loss monitoring.
StatStrip Hb/Hct provides measured hemoglobin and hematocrit results, which are more accurate than calculated results, with excellent correlation to laboratory reference methods. With a fingerstick capillary sample and results in 40 seconds, StatStrip Hb/Hct provides the real-time accuracy that helps improve clinical decision making in a variety of healthcare settings. These include blood banks and temporary blood collection locations, dialysis centres, primary care clinics, hospitals, and oncology clinics. For example, in blood banks, StatStrip Hb/Hct provides safe and effective blood donor screening and avoids false deferrals. For patients receiving dialysis, StatStrip Hb/Hct helps maintain Hb target levels and also monitor erythropoiesis stimulating agents (ESAs) to the lowest effective dose. In emergency care settings and in hospitals, StatStrip Hb/Hct can aid in rapidly evaluating blood loss, initiating treatments more quickly, and monitoring critically ill patients who are at risk for low hemoglobin and hematocrit. In oncology clinics, StatStrip Hb/Hct can help proactively identify patients at high risk for chemotherapy-induced anemia and direct treatment accordingly. StatStrip Hb/Hct’s single-use biosensors do not require calibration or coding, and testing is as easy as glucose self-testing. StatStrip Hb/Hct helps reduce costs by eliminating the need for blood drawing supplies, venous phlebotomy, and laboratory testing. Wired and wireless connectivity for data integration with patient records are available. Compact and lightweight, StatStrip Hb/Hct is less than half the size and weight of other POC systems that measure only hemoglobin.
Read more

The new PICO 7Y single use negative pressure wound therapy system (sNPWT) with AIRLOCK technology includes an innovative integrated Y extension enabling the utilization of two dressings concurrently from one pump, in practice allowing for two wounds to be addressed at the same time, thereby potentially reducing cost.
PICO 7Y sNPWT includes extended soft port and multisite dressings, designed to conform to complex anatomies. It is particularly suited for use on multiple wounds, such as breast surgical procedures. PICO 7Y also includes a check dressing indicator, which is intended to reduce unnecessary dressing changes and wastage and is 23% quieter than the first generation PICO, making it less intrusive for patients.
PICO 7Y is the latest addition to the PICO family of sNPWT products, which have transformed the use of negative pressure wound therapy by making it available to a wider range of outpatients in a cost effective, portable solution. PICO has been shown to significantly reduce wound complications following breast reduction surgery compared with standard dressings. In a breast cancer study with patients undergoing therapeutic mammoplasty, PICO reduced the incidence of post-surgical wound dehiscence by 75% compared with standard care, thereby reducing the potential for delay in the commencement of adjuvant therapy.
Read more

The CE-marked and FDA-cleared Early Sepsis Indicator by Beckman Coulter is a hematology-based solution designed to alert emergency department clinicians to the possibility of sepsis or risk of developing sepsis. It is part of a routine complete blood count (CBC) with differential test for adults entering through ED, so there is no additional test to order. The Early Sepsis Indicator gives physicians a rapid and  simple tool that can aid in the fight against sepsis. Sepsis is an often-deadly condition that affects 26 million people worldwide every year and is increasing at a rate of 1.5% annually. Timely and accurate detection solutions in the acute-care setting are key components to stopping the progression of sepsis, as patients with less severe sepsis can progress to severe sepsis or septic shock within 72 hours. Up to half of patients with sepsis die. In addition to the human toll, this global crisis places a significant clinical and economic burden on the healthcare system. A clear link exists between the timeliness of treatment and the possibility of death. When antibiotics are administered early to patients with septic shock, the likelihood of death is decreased by 7.6% per hour. Because emergency department personnel are often on the front line of care for people facing critical conditions, giving them a simple and easy tool for detecting sepsis can help make significant strides against this prevailing threat. The fact that this early warning indicator is part of a routine blood test means that clinicians receive results rapidly, with no additional workflow burden to the laboratory or emergency department. The Early Sepsis Indicator uses the DxH 900 hematology analyser’s Coulter technology, which characterizes cells in their near-native states. The system’s powerful VCS 360 technology can uniquely detect morphological changes in monocytes – cells of the innate immune system that provide a first line of defence against infections. Monocytes play a role in the dysregulated immune response to sepsis, and identifying morphological changes provides insight into possible sepsis earlier than other indicators.
Read more