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Mortara has been awarded a multi-year contract for ongoing maintenance and support of the FDA ECG Warehouse including continuous ECG studies analyzed by VERITASTM.
Mortara collaborated with the FDA to develop the ECG Warehouse which was initially deployed in 2005. The ECG Warehouse acts as a repository for annotated electrocardiograph (‘ECG’) studies provided to the FDA in support of new drug applications. With the ECG Warehouse, the FDA uses Mortara’s VERITAS ECG algorithms and viewing technologies to review ECG data submitted as part of new drug applications.
Since inception of the ECG Warehouse, more than 9 million resting ECGs have been analyzed with Mortara’s VERITAS algorithms, making this one of the largest cloud-based clinical data repositories in the world. The ECG Warehouse has subsequently been expanded to also include continuous 12-lead recordings, which now number nearly 800 in total. The warehouse tools include web-based upload, navigation of continuous data, arrhythmia identification and waveform morphology comparison.
Under this expanded ECG Warehouse contract, Mortara will continue to support Sponsor and ECG Central Laboratory upload of ECG studies, provide support to FDA personnel and provide on-going basic development enhancements to the ECG Warehouse including advances in the VERITAS ECG algorithms.
‘Mortara is pleased to continue its longstanding relationship with the FDA in providing the ECG Warehouse solution,’ said Dr. Justin Mortara, CEO of Mortara. ‘This award is testimony to our leadership role in ECG acquisition and algorithm technologies. We are honored to be chosen by the FDA and to play our part in the cardiac safety evaluation of new drugs.’
About Mortara
For over 30 years, Mortara Instrument, Inc. has served as a leading designer, developer, and manufacturer of diagnostic cardiology and, most recently, patient monitoring technologies. Mortara is focused on delivering world-class medical devices, as evidenced by its innovative portfolio of solutions designed to serve throughout the continuum of clinical care. The company’s comprehensive range of products spans modalities including resting ECG, cardiac stress exercise, Holter monitoring, cardiac and pulmonary rehabilitation, and ambulatory blood pressure and multi-parameter patient monitoring. Mortara’s global headquarters is located in Milwaukee, Wisconsin with direct operations in Australia, Germany, Italy, the Netherlands, and the United Kingdom. While Mortara distributes its products and technologies globally, it remains dedicated to manufacturing in the United States in order to consistently deliver the quality products for which it is known.
Mortara’s approach to innovation has a global reach that impacts both mature and emerging healthcare systems. To learn more about Mortara and its expanding product portfolio, including the Burdick and Quinton brands, visit www.mortara.com.
We are all aware that there is a dearth of physicians both in primary healthcare and several hospital specialities in the West, an escalating problem that is particularly acute in the case of anesthesiologists. In some European countries this situation is at least partially the result of poor planning and under-investment in medical education, coupled with aggressive attempts to recruit medical professionals overseas, but there are other factors involved that must be addressed before we can hope to consider approaches that could alleviate the problem.
A major contributing factor is that today’s anesthesiologists are not only active in the operating theatre: their expertise is required during patient evaluation prior to surgery, and in critical care and pain management post-surgery. And not only has medical research augmented the number of surgical procedures that are now possible, but Europe’s increasing numbers of senior citizens, who are the most likely to suffer from non-communicable and chronic diseases, are the main beneficiaries of these innovative approaches. Inevitably this results in the demand for anesthesiologists exceeding the supply.
Another factor is that the generation of predominantly male anesthesiologists who focussed on their careers and were prepared to work in the evenings, at night and during weekends and holidays, severely limiting the time they could spend with their families, are retiring and being replaced by younger specialists who are legally entitled to work fewer hours per week and are also aware that social changes in recent decades, allowing both genders to enjoy satisfactory careers, require them to contribute practically (as well as financially) at home.
There is also a shortage of surgeons in Europe but this problem is not so acute as with anesthesiologists. Sadly this may well be because of the greater prestige enjoyed by practitioners of the former specialization, a situation which should surely be an anachronism. It is to be hoped that the primary goal of all medical professionals is to help their patients but until all specialisms are equally valued and respected for their essential contribution to patient care, some will continue to attract fewer recruits than others. There could even be a long-term solution to the problem if physicians themselves, including anesthesiologists, would value and respect non-medical healthcare professionals as they deserve. Surely the ever evolving technologies available in critical care settings and the relevant training offered could allow specialized anesthesia nurses to be trusted to administer anesthesia for certain procedures and patients, as well as sedation and pain relief, without requiring direct supervision from on high?
This was the theme for the 29th World AIDS Day on December 1st. Substantial progress has been made in developing and disseminating effective antiretroviral therapy (ART) for people diagnosed with HIV/AIDS. Indeed for the around 19 million people globally currently taking ART, the disease can be considered a chronic condition, albeit one that requires careful and continuous monitoring.
Huge strides have also been made in reducing transmission of infection. Concerted efforts by national programmes and development partners have promoted safe sex and condom use (though not without some controversy and pontification about the value of celibacy) with studies showing that this reduces HIV transmission by 85percent. Medical male circumcision, which reduces the risk of heterosexual men becoming infected by an estimated 60percent, is also becoming acceptable in high risk countries where performance of this operation is not the cultural norm. The efficacy of pre-exposure prophylaxis (PrEP) for subjects at a high risk of becoming infected with HIV, such as those with infected sexual partners, has been demonstrated and is advocated in many countries. Vertical transmission, formerly accounting for up to 45percent of babies acquiring the infection from their HIV positive mother, can now be prevented by prescribing ART to both mother and child during pregnancy, labour, delivery and breastfeeding. And programmes have been set up both to educate people who inject recreational drugs about the risks of HIV infection and to provide sterile injecting equipment to reduce the risk.
However an enormous obstacle blocking the goal to end the AIDS epidemic by 2030 is that according to the WHO an estimated 14 million people (around 40percent of all people with HIV) are unaware that they are infected with the virus. Not only are they not receiving ART, they are also unwittingly infecting others. Highly accurate rapid diagnostic tests or enzyme immunoassays are available, but many people are either geographically distant from such testing services or are too diffident to access them. So it is wonderful news that, according to WHO, twenty-three countries have so far approved policies for HIV self-testing, and many others are aiming to follow suit. Studies have shown that with such testing, performed in the privacy of one’s home with results available after 20 minutes, the number of people tested doubles. While there is great need to distribute kits to the most high risk areas, how many of us currently living in lower risk countries are celibate until we meet our life partner who has also been celibate prior to meeting us?
While mammography remains the gold standard for detecting breast cancer, research has shown it is not equally effective in all women. In the 40percent of with dense breast tissue, mammography can miss up to one third of breast cancers. This may lead to a delay in diagnosis and a worse prognosis for women with dense breast tissue. Mammography has been shown to miss 30percent of cancer in dense breasts. Using screening ultrasound for women with dense breasts is helping address this challenge. However, the limitations of traditional hand-held ultrasound (HHUS), which include operator dependency, variability and long acquisition times, make it inefficient for broad-scale breast cancer screening. With the introduction of ABUS (automated breast ultrasound), clinicians are able to address these variables and shorten both exam and read times, while increasing sensitivity with a multi-modality approach.
New findings from a Swedish study show a 57percent relative increase in breast cancer detection in women with dense breast tissue when ABUS was used together with mammography.
The system is found to have significantly improved cancer detection in women with dense breast tissue when used together with mammography.
The European Asymptomatic Screening Study (EASY) aimed to evaluate the impact of ABUS in conjunction with full field digital screening mammography (FFDSM) in 1,668 women aged 40-74 with dense breasts. The study showed a 57 percent relative increase in breast cancer detection in dense breast tissue, compared with mammography alone.
‘If ABUS would be a part of national screening programmes in dense breasts, more cancers could be detected at an earlier stage. Many countries are working to try to optimize screening so that each woman can get examinations according to her assessed risk,’ said Dr Brigitte Wilczek, lead researcher on the EASY study.
Dense breast tissue is linked with an increase in the risk of developing cancer. It also makes detecting cancer more difficult. This is because both masses and breast tissue appear white in the mammogram, which makes the search for masses like a search for a snowball in a snowstorm. By contrast, masses appear dark against white tissue with ultrasound technology.
Dense breasts are particularly common in younger women and seems to reduce with age, as on average 74percent of women in their 40s, 57percent of women in their 50s, 44percent of women in their 60s and 36percent of women in their 70s have dense breast tissue.
In the study, published in the European Journal of Radiology, FFDSM was first used in the examination followed by a 3D ABUS exam which took 15 minutes to complete per patient. The inclusion criteria for the women in the study was that they be 40 years or older, asymptomatic, and have heterogeneously dense parenchyma or extremely dense breast on assessment by the radiographer in the screening.
‘The study shows that it is feasible to implement 3D ABUS into a high volume mammography center and increase the cancer detection rate while maintaining an acceptable low recall rate,’ said Dr Wilczek.
The recall rate for ABUS and FFDSM combined was only +0.9percent compared to FFDSM alone. This is an acceptable low recall rate well within the recommendations of the European guidelines for quality assurance in breast cancer screening.
www.gehealthcare.comMortara Instrument’s new family of Surveyor WiFi telemetry solutions is designed to offer diagnostic-quality ECG acquisition and to work on the existing WiFi network, with no need for a dedicated network infrastructure. Its outstanding features have been the key decision factors for Policlinico San Donato (Milan, Italy), one of the top-ranking centers for the study and treatment of cardiovascular diseases, to select Mortara telemetry system.
Mortara designed the Surveyor S4 solution based on three main criteria: cost saving, coverage and clinical excellence.
Cost is a major priority of today’s healthcare professionals and also one of Mortara’s top concerns. The Surveyor S4, thanks to its advanced design, can operate on existing WiFi infrastructure to broadcast physiological signals. It eliminates the cost of a proprietary antenna network, which is required by traditional telemetry systems. Removable, rechargeable batteries allow a lower ecological footprint than disposable batteries, while also reducing running costs.
Coverage (i.e. the areas where the patients can be monitored) is also revolutionized with the Surveyor S4; the use of WiFi technology allows patients to be monitored virtually wherever the WiFi signal is available throughout the facility. This means more freedom for the patient, but also extends patient monitoring to more departments; the ability to clinically monitor and evaluate patients is enhanced without additional beds being added to the traditional telemetry area.
Mortara takes pride in delivering clinical excellence. VERITASTM is the suite of algorithms created by Mortara to analyze ECG signals. The Surveyor S4 family includes the latest algorithms that provide clinicians with absolute reliable data. From basic to lethal arrhythmias, VERITAS is the ideal companion for clinicians. In addition, all Surveyor S4 mobile monitors offer diagnostic quality acquisition; combined with the true 12-lead ECG amplifier, they offer best-in-class 12-lead ST segment analysis. True 12-lead ECG monitoring allows physicians to detect early ST segment changes and obtain a complete evaluation of the cardiac profile of the patient, without additional tests.
Founded in 1969, IRCCS Policlinico San Donato is part of an 18-hospital network that provides over 5,000 beds, and is also host to the Medicine School of the University of Milan. The clinical arrhythmology and electrophysiology ward, run by Professor Carlo Pappone, is one of the international excellence centers for the treatment of all types of cardiac arrhythmias.
Atrial fibrillation, Brugada syndrome, Wolff-Parkinson-White (WPW) syndrome, and cardiac electro-stimulation are among the main research fields. In particular, the research on, and treatment of, supraventricular arrhythmias is a primary focus and area of expertise for this group of clinicians, as testified by the number of publications on international top-ranking journals, and directly witnessed by the large population of patients who have already successfully undergone trans-catheter ablation procedures.
Given the outstanding reputation of his center, Professor Pappone has chosen Mortara as the best-in-class partner in order to deliver excellent diagnosis and treatment.
Policlinico San Donato is one of the many centers where the Mortara monitoring solutions have been adopted and that every day helps to improve healthcare throughout the world.
January | February 2024
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Beukenlaan 137
5616 VD Eindhoven
The Netherlands
+31 85064 55 82
info@interhospi.com
PanGlobal Media IS not responsible for any error or omission that might occur in the electronic display of product or company data.
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