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EYEMATE System for Remote Glaucoma Management Obtains FDA Breakthrough Device Designation

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EYEMATE system for digitally-enabled remote patient monitoring and management of glaucoma has obtained Breakthrough Device Designation (BDD) from the U.S. Food and Drug Administration (FDA).

A BDD is only assigned for breakthrough technologies that have the potential to provide more effective treatment of life-threatening or irreversibly debilitating diseases in order to provide patients and physicians more timely access to such technologies without compromising safety.

The patented EYEMATE system is the world’s only clinically-validated product used for comprehensive remote glaucoma monitoring. It empowers patients with the ability to measure their intraocular pressures from anywhere and anytime, and then automatically send that information in real-time to their doctor. This information empowers doctors to adjust glaucoma therapy based on a patient’s current condition rather than make therapeutic adjustments only during an office visit.

Max G. Ostermeier, CEO and Founder of Implandata states: “We are extremely pleased to move forward under the FDA BDD program, as we will benefit from additional FDA input during the premarket development as well during the submission process and through an expedited review once the submission is filed. With FDA market authorization, the EYEMATE system will now be entitled to Medicare Coverage of Innovative Technology for at least 4 years, offering beneficiaries predictable access to the breakthrough EYEMATE system, helping to improve their health outcomes.”

Robert N. Weinreb, M.D., Chair and Distinguished Professor of Ophthalmology at University of California, San Diego and Implandata Medical Advisor stresses: “The BDD for the EYEMATE system is exciting news. It is an important step towards developing a digital platform for using intraocular pressure and other diagnostic data to enhance management of glaucoma patients.”

Kaweh Mansouri, M.D., M.P.H, Consultant Ophthalmologist at Clinique de Montchoisi Lausanne/Switzerland, Adjoint Professor at the Department of Ophthalmology, University of Colorado, Denver, and Implandata’s Chief Medical Officer elaborates: “Our clinical experience with the EYEMATE system in Europe has been very positive as evidenced by over a 100.000 pressure readings that have been taken by patients who have had the EYEMATE sensor implanted. The real-life information provided by the EYEMATE system enables eye care specialists to better understand a patients’ disease and to apply more effective treatments in a timely fashion. And patients are empowered via self-monitoring, resulting in improved therapy adherence.”

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Source: https://infomeddnews.com/eyemate-system-fda-breakthrough-device-des/

Medical Devices

Overcoming disparities in access to care for communities of color

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This year, more than 5 million Americans will be diagnosed with Heart Valve Disease. All too often, for Black patients with certain forms of the disease this can be a death sentence, with patients from minority communities facing significantly higher mortality rates than their white counterparts.

The most common form of this disease is aortic stenosis (AS), where the aortic valve narrows and weakens the heart. While common, AS can be deadly, and one in six patients will have a more aggressive form called symptomatic severe aortic stenosis (SSAS), that can be fatal within two years without treatment.

Diseases like SASS and other chronic diseases lay bare stark inequities in our health care system, in which our Black patients are disproportionately impacted. When we see patients with SSAS, treatment options include two approaches to repair their failing valve, one that involves open-heart surgery and one that is minimally invasive. The latter, transcatheter aortic valve replacement (TAVR) provides eligible patients with quicker procedure times and a shorter recovery. All in all, this means they can spend less time in the hospital, compared to the standard surgical aortic valve replacement (SAVR).

Yet, Black patients with SSAS are not being given the same treatment options as their white counterparts and are being left behind when it comes to the benefits of TAVR. This gap is reflected by the nearly a three-fold difference between the likelihood of non-Black patients receiving TAVR compared to white patients. In 2018 alone, only 14.4% of Black patients had a TAVR procedure compared to 24.4% of white patients with the same diagnosis. Furthermore, major randomized clinical trials of TAVR are falling short in including adequate representation of Black patients all together.

The effects of this disparity aren’t simply unjust, they are possibly fatal – spelling out a much greater risk of death and hospital readmission following surgery.

Disparities like this don’t just impact heart valve disease patients. They are insidious within our care system. In Baton Rouge, I’ve seen these disparities brought into sharp focus by the Covid-19 pandemic. Significant issues in access exist across the care continuum, with Black patients traveling farther and facing more barriers to receiving the vaccine since their neighborhoods are being left out of the roll-out. Everyday families are choosing between getting the care they need or missing a full day of work at the cost of losing critical income. This is the same pattern we are seeing in how Black patients and those impacted by poverty are accessing TAVR centers, or lack thereof. It comes as no surprise that thes odds of getting TAVR increase 10% for every $10,000 increase in income.

While there is much to be done to close the gap, it is more important than ever to start making progress. We know that inequities in care for AS have increased over the last seven years, and the rates of heart valve disease are only expected to grow as the population ages.

Uncovering these disparities is just first step working towards equal access and quality of care for communities of all races. National and local initiatives can help carry this out in full stride. With the AS Disparities of Care Pilot Program, four health systems across the country are working to address inequalities within their communities to create nationwide change in heart valve disease care.

By prioritizing patient awareness, we can help patients, who might otherwise have been undiagnosed and undertreated, understand the signs and symptoms of heart valve disease.  Further, by meeting patients where they are primed to receive information, we can help them understand their full range of options for AS so that they are equipped to be an informed decision-maker for their health.

Photo: FG Trade, Getty Images

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Source: https://medcitynews.com/2021/05/overcoming-disparities-in-access-to-care-for-communities-of-color/

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Medical Devices

Overcoming disparities in access to care for communities of color

Avatar

Published

on

This year, more than 5 million Americans will be diagnosed with Heart Valve Disease. All too often, for Black patients with certain forms of the disease this can be a death sentence, with patients from minority communities facing significantly higher mortality rates than their white counterparts.

The most common form of this disease is aortic stenosis (AS), where the aortic valve narrows and weakens the heart. While common, AS can be deadly, and one in six patients will have a more aggressive form called symptomatic severe aortic stenosis (SSAS), that can be fatal within two years without treatment.

Diseases like SASS and other chronic diseases lay bare stark inequities in our health care system, in which our Black patients are disproportionately impacted. When we see patients with SSAS, treatment options include two approaches to repair their failing valve, one that involves open-heart surgery and one that is minimally invasive. The latter, transcatheter aortic valve replacement (TAVR) provides eligible patients with quicker procedure times and a shorter recovery. All in all, this means they can spend less time in the hospital, compared to the standard surgical aortic valve replacement (SAVR).

Yet, Black patients with SSAS are not being given the same treatment options as their white counterparts and are being left behind when it comes to the benefits of TAVR. This gap is reflected by the nearly a three-fold difference between the likelihood of non-Black patients receiving TAVR compared to white patients. In 2018 alone, only 14.4% of Black patients had a TAVR procedure compared to 24.4% of white patients with the same diagnosis. Furthermore, major randomized clinical trials of TAVR are falling short in including adequate representation of Black patients all together.

The effects of this disparity aren’t simply unjust, they are possibly fatal – spelling out a much greater risk of death and hospital readmission following surgery.

Disparities like this don’t just impact heart valve disease patients. They are insidious within our care system. In Baton Rouge, I’ve seen these disparities brought into sharp focus by the Covid-19 pandemic. Significant issues in access exist across the care continuum, with Black patients traveling farther and facing more barriers to receiving the vaccine since their neighborhoods are being left out of the roll-out. Everyday families are choosing between getting the care they need or missing a full day of work at the cost of losing critical income. This is the same pattern we are seeing in how Black patients and those impacted by poverty are accessing TAVR centers, or lack thereof. It comes as no surprise that thes odds of getting TAVR increase 10% for every $10,000 increase in income.

While there is much to be done to close the gap, it is more important than ever to start making progress. We know that inequities in care for AS have increased over the last seven years, and the rates of heart valve disease are only expected to grow as the population ages.

Uncovering these disparities is just first step working towards equal access and quality of care for communities of all races. National and local initiatives can help carry this out in full stride. With the AS Disparities of Care Pilot Program, four health systems across the country are working to address inequalities within their communities to create nationwide change in heart valve disease care.

By prioritizing patient awareness, we can help patients, who might otherwise have been undiagnosed and undertreated, understand the signs and symptoms of heart valve disease.  Further, by meeting patients where they are primed to receive information, we can help them understand their full range of options for AS so that they are equipped to be an informed decision-maker for their health.

Photo: FG Trade, Getty Images

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Source: https://medcitynews.com/2021/05/overcoming-disparities-in-access-to-care-for-communities-of-color/

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Medical Devices

Get Instant Instagram Followers and Likes with GetInsta

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GetInsta App is 100% safe and secure to get benefits from online smart feature plans. There are lots of reliable and smart feature explorations to achieve your objectives. Getting online fast accessibility features means showing your personal interests and having great explorations of plans means showing your credibility and having useful acknowledgment about efficient use of the GetIntsa. Get real and organic Instagram followers free on Instagram to access the online guaranteed apps to proceed with an instant and reliable source of action plans. Getting online and fast accessibility features can proceed and approach with reliable resources.

instagram

Unlimited free Instagram followers & likes can be enhanced to enhance the free Instagram profile. Proceeding with easy ad smart feature explorations means having personal interests and having useful resources means showing your credibility to enhance your Instagram likes to increase the credibility of the Instagram profile. 100% safe and 24/7 support can be achieved with easy and reliable resources. Find lots of attractive and user-friendly plans to enhance your Instagram profile and proceed to achieve your objectives.

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There are numerous plans and useful strategies used by interested people who like to become experts to enhance their profile reputation with easy and simple approaching plans. Find user-friendly and creative minds apps and tools which can be effective and fast result-oriented to increase free Instagram followers and likes. There is no fee and sign-in process to access the GetInsta but anyone from anywhere at any time.

Proceed with easy and simple approaching standards to proceed with smart choices and to show your interests to increase free likes and followers from authentic resources. Getting the best and smart choices to increase free Instagram likes and followers can proceed to achieve your objectives and to get the best response to enhance your Instagram profile. Companies and brand stake interests to increase the brand credibility to increase their sales and to inspire the people to achieve your objectives. Find lots of attractive plans and interesting ideas to enhance your profile reputations.

Celebrities and Instagram users who like to get famous and want to show their person’s presence among the fans like to choose the best and authentic useful resources which can be favorable and which can be valuable for them to meet their objectives. Get the best chance to improve their profile credibility and increase free Instagram followers and likes to proceed with step-by-step integration of plans. Show your interests and preferences to proceed with easy and simple approaching standards to increase Instagram profile credibility.

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Source: https://infomeddnews.com/getinsta-instagram-followers-likes/

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Medical Devices

Get Instant Instagram Followers and Likes with GetInsta

Avatar

Published

on

GetInsta App is 100% safe and secure to get benefits from online smart feature plans. There are lots of reliable and smart feature explorations to achieve your objectives. Getting online fast accessibility features means showing your personal interests and having great explorations of plans means showing your credibility and having useful acknowledgment about efficient use of the GetIntsa. Get real and organic Instagram followers free on Instagram to access the online guaranteed apps to proceed with an instant and reliable source of action plans. Getting online and fast accessibility features can proceed and approach with reliable resources.

instagram

Unlimited free Instagram followers & likes can be enhanced to enhance the free Instagram profile. Proceeding with easy ad smart feature explorations means having personal interests and having useful resources means showing your credibility to enhance your Instagram likes to increase the credibility of the Instagram profile. 100% safe and 24/7 support can be achieved with easy and reliable resources. Find lots of attractive and user-friendly plans to enhance your Instagram profile and proceed to achieve your objectives.

Buy followers now and become famous on Instagram to access online free and easy approaching standards to achieve your objectives. Almost everything is based upon the priorities and the interests levels to proceed with reliable resources. Social network users always like to get instant fame and to proceed with easy and instant reliable resources. Getting the ultimate Instagram auto liker tool to get free Instagram followers and likes can be a favorable and smart feature plan to increase your free Instagram profile reputation.

Picture1

There are numerous plans and useful strategies used by interested people who like to become experts to enhance their profile reputation with easy and simple approaching plans. Find user-friendly and creative minds apps and tools which can be effective and fast result-oriented to increase free Instagram followers and likes. There is no fee and sign-in process to access the GetInsta but anyone from anywhere at any time.

Proceed with easy and simple approaching standards to proceed with smart choices and to show your interests to increase free likes and followers from authentic resources. Getting the best and smart choices to increase free Instagram likes and followers can proceed to achieve your objectives and to get the best response to enhance your Instagram profile. Companies and brand stake interests to increase the brand credibility to increase their sales and to inspire the people to achieve your objectives. Find lots of attractive plans and interesting ideas to enhance your profile reputations.

Celebrities and Instagram users who like to get famous and want to show their person’s presence among the fans like to choose the best and authentic useful resources which can be favorable and which can be valuable for them to meet their objectives. Get the best chance to improve their profile credibility and increase free Instagram followers and likes to proceed with step-by-step integration of plans. Show your interests and preferences to proceed with easy and simple approaching standards to increase Instagram profile credibility.

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Source: https://infomeddnews.com/getinsta-instagram-followers-likes/

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