GE Healthcare and Medtronic Collaborated to Meet the Increasing Need for Outpatient Care

On April 28, 2022, GE Healthcare and Medtronic entered into a collaboration to provide patients, clinicians, and payers seeking more choices of excellent care, inside and outside of the traditional hospital without compromising excellent outcomes. Under this collaboration, customers can access an extensive product portfolio, financial solutions, and exceptional service. Moreover, through this collaboration, both the companies are focused on the unique needs and demand for care at Ambulatory Surgery Centers (ASCs) and Office-Based Labs (OBLs).

The outbreak of the COVID-19 pandemic hastened the movement of procedures into the outpatient environment, resulting in procedure growth in facilities outside traditional hospitals. This growth is anticipated to continue in the upcoming years. Additionally, after the CMS-approved payments for certain cardiovascular procedures in the year 2020, there has been an increased and frequent usage of c-arm imaging systems in ASCs and OBLs for cardiac and peripheral vascular procedures.

Furthermore, with an increasing patients need, there remain the challenges of high costs for expanding an existing ASC or building a new one. Thus, both the companies are bringing the best of each company to deliver high-quality and cost-effective advanced technology, financial solutions, and personal service to help ASCs navigate these challenges. For GE Healthcare, this includes consultative planning, construction, a comprehensive suite of equipment (including imaging, monitoring, and ultrasound), and exceptional service and digital solutions, including the Edison-powered AutoRight A.I.-based interventional imaging chain, which can help clinicians provide the right image at the right dose automatically for each patient. Whereas, Medtronic will provide an extensive portfolio of its products for a diverse range of service lines in the ASC and OBL, from cardiac rhythm to pain management, and peripheral vascular to kyphoplasty. In addition to products, Medtronic will continue to offer services such as reimbursement support, remote solutions, and more.

Jim Rapp, vice president of Interventional Imaging at GE Healthcare, said, “GE Healthcare Interventional Imaging solutions are built to help our customers deliver care at a higher level for patients. With a predicted increase in outpatient cardiology and peripheral vascular procedures over the coming years, industry leaders like GE Healthcare need to understand and meet the unique needs of ASCs and OBLs. Our collaboration with Medtronic is one aspect of our efforts to strengthen efficiency, workflow, and clinical outcomes for ASCs and OBLs who work with GE Healthcare.”

“As our customers open centers outside of the hospital, they are looking for support beyond the devices used in medical procedures. From products and devices to equipment and services, we provide a full range of technologies and solutions. Our collaboration with GE Healthcare was formed to better serve the growth of our ASC and OBL customers with extensive technologies and dedicated teams who have expertise in outpatient services and can address all aspects of this evolving sector.” said Adam King, senior director of U.S. Enterprise Accounts and Ambulatory Surgery Centers at Medtronic.

According to DelveInsight’s Analysis, the Interventional Radiology Devices Market is likely to witness significant growth during the forecast period (2019-2027) owing to an increase in the preference for minimally-invasive procedures among the patients because of its cost-effectiveness and lesser hospital stay. Furthermore, innovations in imaging technologies, which provide real-time images to surgeons to show a comprehensive view of internal organs while diagnosing, and the rising prevalence of various chronic diseases such as cancer, cardiovascular disorders, and neurological disorders, among others are driving the interventional radiology market.

Additionally, According to DelveInsight’s “Pain Management Devices Market” report, the global pain management devices market is expected to grow at a CAGR of 7.90% during the forecast period from 2022 to 2027. The demand for pain management devices is primarily motivated by the rise in prevalence of chronic pain, high prevalence of musculoskeletal disorders, surge in geriatric population, surge in awareness among people toward pain management devices, improved R&D investment to develop innovative products, and increasing cost of healthcare expenditure. In addition, as per the Delveinsight analyst, North America is expected to dominate the overall pain management devices market share during the forecast period due to the growing demand for advanced technologies in pain management devices, and the increasing cases of chronic pain in the region and others.

Vektor Medical’s vMap Clinical Validation Study Demonstrated 97.3% Mapping Accuracy for Atrial and Ventricular Arrhythmias

On April 28, 2022, Vektor Medical, San Diego-based company, declared positive results from its clinical validation study evaluating the accuracy of cardiac mapping with vMap. vMap is an FDA-cleared, computational mapping system used for identifying arrhythmia sources anywhere in the heart using only 12-lead electrocardiogram (ECG) data. 

The study achieved significant results of 98.7% in accurately identifying the regional arrhythmia source location for premature ventricular complex (PVC) and ventricular tachycardia (VT), 96.9% in accurately identifying the regional arrhythmia source for the arrhythmias and pacing types studied, and 97.3% segment mapping accuracy in all nine arrhythmia and pacing types included. The result of the study was presented at Heart Rhythm 2022 on April 29, 2022.

Highlights of the vMap Clinical Validation Study

The results from the study showed:

  • Regional accuracy for VT and PVCs in patients without significant structural disease (primary endpoint) was 98.7% (95% Cl: 96.0% -100%, p<0.0001)
  • Regional accuracy for all episodes (secondary endpoint one) was 96.9% (95% Cl: 94.7%-99.0%, p<0.001)
  • Exact or neighboring segment accuracy for all episodes (secondary endpoint two) was 97.3% (95% Cl: 95.2%-99.3%, p<0.001)
  • Median center-to-center spatial accuracy was 15 mm
  • The mapping process was completed in a median of 0.8 minutes

Dr. David Krummen, Professor of Medicine at the University of California San Diego, co-founder and inventor of Vektor Medical commented, “These results represent an exciting development in cardiac arrhythmia care and a significant step forward for the EP community in being able to better understand where arrhythmia sources are located. vMap offers physicians the opportunity to provide a higher quality of care for patients by improving first pass ablation success, lowering risks from invasive mapping and fluoroscopy exposure, and reducing procedure times, all while fitting into the clinical workflow. “

“This blinded study was intentionally designed with challenging pre-specified endpoints to test the accuracy and efficiency of vMap. We are delighted with the study results as they demonstrate the potential for the technology to improve ablation outcomes and arrhythmia care for millions of patients,” added Mike Monko, CEO of Vektor Medical

According to DelveInsight’s Analysis, the Cardiac Arrhythmia Monitoring Devices Market is expected to show stellar growth in the forthcoming years. This is due to the increasing use of telecardiology, ease of use and portability of cardiac arrhythmia monitoring devices, and the development of smart cardiac monitors. Further, a large population suffering from arrhythmias across the globe is also a factor contributing to the market. In addition, as per the analysis, Within North America, the United States cardiac arrhythmia monitoring devices market is estimated to witness robust growth, due to the increasing adoption of advanced cardiovascular solutions and sophisticated healthcare infrastructure. For instance, in January 2022, the United States Food and Drug Administration (USFDA) granted 510(k) clearance to Biotricity’s Biotres Cardiac Monitoring Device for ECG and arrhythmia monitoring. Biotres Cardiac Monitoring Device offers a wearable Holter patch device to provide continuous three-channel recording of ECG data. Thus, all the mentioned factors are projected to contribute to the market growth of cardiac arrhythmia monitoring devices during the forecast period.

iSono Health’s ATUSA™, the World’s First Automated, and Wearable 3D Breast Ultrasound Received FDA Clearance

On May 03, 2022, iSono Health, Inc. received FDA approval for ATUSA™ System, developed for breast imaging. The system is a first-of-its-kind compact automated whole breast ultrasound system comprising a unique wearable accessory and software for automated image acquisition and analysis. Moreover, the system is a portable device that automatically scans the entire breast volume, independent of operator expertise, and offers 3D visualization of the breast tissue in just two minutes.

Maryam Ziaei, Ph.D., co-founder, and CEO of iSono Health, said, “Breast cancer is the leading cause of cancer death among women worldwide, and one in eight women will be diagnosed with breast cancer in their lifetime. We founded iSono Health with the vision to enable earlier diagnosis and treatment for breast cancer to save women’s lives, and this FDA clearance is a major step to fulfilling that vision.”

Brian Cochrane, Chief Commercial Officer of SMART’s U.S. subsidiary added, “We expect that this FDA clearance of the G-EYE® Colonoscope based on Olympus’ PCF scopes, which many Olympus users prefer over traditional adult-sized colonoscopes, will enhance our ability to capture a substantial portion of the U.S. colonoscopy market. We are committed to becoming the standard of care in colonoscopy, and this FDA clearance is an important step toward achieving this critical goal.” She added,” Clinicians and women worldwide need high-quality breast imaging that is accessible and efficient at scale, without the need for highly skilled operators. The portable and automated ATUSA system stands alone in comparison to other ultrasound offerings in promising to address that need. We are thrilled to be able to get ATUSA into the market and have the opportunity to help save lives.”

According to DelveInsight’s ‘Breast Cancer Diagnostics Market” report, the global Breast cancer diagnostics market was valued at USD 4.20 Million in 2021, growing at a CAGR of 6.66% during the forecast period from 2022 to 2027 to reach USD 6.16 Million by 2027. The Breast cancer diagnostics market is witnessing a positive growth owing to the factors such as the increasing prevalence of breast cancer, increasing age and sedentary lifestyle,  technological advancements, government initiatives to increase the rate of screening and diagnosis, thereby all factors contributing to the growth of Breast cancer diagnostics market during the forecast period from 2022-2027. Also, as per the analyst, in the test type, mammography which is a sub-segment in imaging tests is expected to hold a significant share in the year 2021, this is because it has certain benefits associated with it such as it is a low-dose x-ray image of breast tissue, helps in the early detection of breast cancer which can be timely treated, and reduces risks of having chemotherapy. Therefore, an increase in such factors increases the mammography demand which results in the growth of the breast cancer diagnostics market.

Mirvie Granted FDA Breakthrough Device Designation for its First Test Designed to Early Detect the Risk of Preeclampsia

On May 03, 2022, Mirvie, a South San Francisco, California based company and a pioneer in predicting unexpected complications associated with pregnancy, was granted the US Food and Drug Administration (FDA) Breakthrough Device designation for its test to indicate a woman’s individualized risk of developing preeclampsia before symptoms occur. 

The test uses the proprietary Mirvie RNA platform which uses a simple blood test to reveal vital information about a pregnancy’s unique biology and detect complications months before they occur. The designation received is likely to expedite the development of medical technologies that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. With the received designation, the company will continue ongoing clinical research to further validate the Mirvie Preeclampsia Test performance and improve the understanding of preeclampsia.

Maneesh Jain, Ph.D., Co-Founder, and CEO of Mirvie commented, “This designation shows the FDA recognizes the chasm between what’s available to expecting parents and doctors today and the need for a breakthrough to address this enormous problem. Pregnancy health must become proactive, preventive, and personalized for the well-being of expecting parents and babies. Ever-growing clinical evidence shows the Mirvie RNA platform is charting a new course to make that possible.”

Eleni Tsigas, CEO of the Preeclampsia Foundation said, “Prenatal care as we know it in the United States was first developed to primarily diagnose preeclampsia, yet these protocols have not changed in over fifty years. Moms and babies deserve more – there is an urgent need for innovation that not only identifies the risk of developing preeclampsia early but also helps bring pregnancy health into the 21st century.”

According to DelveInsight’s “Molecular Diagnostic Market” report, the molecular diagnostic market was valued at USD 9.56 billion in 2020, growing at a CAGR of 9.21% during the forecast period from 2021 to 2026, to reach USD 16.12 billion by 2026. The increase in demand for the molecular diagnostic is primarily attributed to the growing incidence of infectious diseases such as the sudden outbreak of COVID-19 and the rising burden of cancers across the globe. Moreover, rapid technological advancement in the molecular diagnostic product arena and increasing demand for point-of-care diagnostics along with rising consumer awareness regarding quick diagnostics, among others are some of the key factors responsible for the molecular diagnostic market growth during the forecasted period. Additionally, as per the analyst, in the Molecular Diagnostic technology segment, polymerase chain reaction (PCR) technology is anticipated to hold a significant market share during the forecasted period. This is because the sudden outbreak of the pandemic has increased the real-time reverse transcriptase-polymerase chain reaction (RT-PCR) test rate across the globe, as the technique is highly sensitive and specific and can deliver a reliable diagnosis of the infection in as little as two to three hours.

First Patient Outside of the United States Treated with TRIA Biopolymer Surgical Aortic Heart Valve in India Clinical Trial

On May 03, 2022, Foldax®, a company focused on developing surgical and transcatheter valves, declared that the first patients have been enrolled in the Drugs Controller General of India (DCGI)-approved clinical trial of the TRIA™ biopolymer surgical aortic heart valve. The trial is studying the ability of the TRIA biopolymer aortic valve to surgically treat patients with aortic valve disease and is designed to support commercial approval in India.

The TRIA valve combines the company’s proprietary biopolymer – LifePolymer™ – with an innovative valve design to prevent calcification, withstand stresses and strains without failure, and restore patient quality of life without lifelong use of anticoagulants. 

Dr. Kaushal Pandey at P.D. Hinduja Hospital in Mumbai, India has performed the procedures.

Foldax CEO Frank Maguire, said, “We are excited to be able to offer our novel TRIA valve to patients internationally for the first time. It is uniquely suited to the Indian market, whose dependence on mechanical heart valves leaves patients with a compromised quality of life. This study is designed to determine the TRIA valve’s ability to offer good hemodynamics and patient improvement safely, without patient dependence on blood-thinning medication, which should offer the quality of life benefits. Assuming we achieve regulatory approval in India in the future, our robotic manufacturing pod platform is designed to easily and efficiently manufacture the valve anywhere in the world without the need for a large skilled workforce or large manufacturing facilities.”

“We are honored to be the first center outside of the U.S. to implant the TRIA heart valve. Our first few cases have gone very well – implantation has been successful, early hemodynamic results have been encouraging, and the patients have all been quickly discharged home. We look forward to completing enrollment in the study in the next few months and seeing how this novel biopolymer heart valve can improve the lives of our patients,” said Dr. Pandey.

According to DelveInsight’s “Transcatheter Aortic Valve Replacement Devices Market” report, the global Transcatheter Aortic Valve Devices Market is expected to grow at a CAGR of 15.41% during the forecast period from 2022 to 2027. The demand for transcatheter aortic valve replacement devices is primarily being boosted by the increasing prevalence of aortic stenosis disorder, rise in cardiovascular disorders, increasing demand for TAVR procedures, increasing prevalence of aortic regurgitation, and the technological advancements in the transcatheter aortic valve replacement arena which are expected to increase in the product demand thereby contributing in the growth of the transcatheter aortic valve replacement devices market during the forecast period from 2022-2027. The analysis also demonstrated that in the application segment of the transcatheter aortic valve replacement devices market, the TAVR devices used in the aortic stenosis segment are estimated to hold a significant share in the transcatheter aortic valve replacement devices market during the forecast period. This can be ascribed to the increasing prevalence of aortic stenosis disorder globally, approval, and launch of TAVR devices indicated for use in aortic stenosis disorder.

Vivalink Launched World’s First Multi-Vital Blood Pressure Patch for Remote Patient Monitoring

On May 03, 2022, Vivalink, a leading provider of digital healthcare solutions for virtual patient care and decentralized clinical trials, launched the world’s first multi-vital blood pressure patch for remote patient monitoring for use in research and development. 

The device is an advanced multimodal continuous signal processing patch that uses electrical signal-based technologies to capture ECG trace, heart rate, and respiratory rate, systolic and diastolic blood pressure. It is FDA/NMPA cleared for ECG and heart rate, and CE cleared for ECG, heart rate, and respiratory rate. Recently the blood pressure feature is integrated and made commercially available. It weighs 7.5 grams and is the size of a small bandage. Moreover, it is a reusable and rechargeable wearable patch that requires no additional components such as a wristband or wires to capture blood pressure. 

Jiang Li, CEO at Vivalink said, “We pride ourselves in continuous innovation. This milestone further establishes Vivalink as a leader and innovator in the remote patient monitoring market.”According to the analysis done by DelveInsight, the Patient Monitoring devices market will propel owing to the rising cases of COVID-19 pandemic. Currently, numerous countries have started to improve their healthcare systems, which is the same across the development and the developing/emerging countries. Hence, as a preventive measure, governments across the world have started building new hospitals and quarantine centres, where patient monitoring is kept as the utmost priority. Henceforth, it requires patient monitoring devices, such as respiratory monitoring devices and body temperature devices. Moreover, the companies are increasing their manufacturing of essential medical device products. For instance, In March 2020, according to the press release from Royal Philips, it is set to scale up the production of certain critical care products and solutions, to help detect and provide treatment for patients with COVID-19. The products include patient’s vital signs monitor, portable ventilators, and medical consumables for non-invasive and invasive ventilation to treat various respiratory conditions. Therefore, such initiatives from companies are expected to help the market and the patients in their treatment which will drive the market growth also. Furthermore, as per the analysis, in the type of devices segment, cardiac monitoring devices are expected to hold the largest share in the market as continuous cardiac monitoring is an important tool in the clinical assessment of patients, with a variety of conditions.