Asahi Intecc partners with Penumbra to roll out Indigo System in Japan

On September 22, 2022, Asahi Intecc, a Surgical and medical instrument manufacturing company, partnered with Penumbra, a medical device company headquartered in Alameda, California, to roll out Indigo System in Japan.

After getting regulatory permission, US-based Penumbra partnered with Japanese medical device maker Asahi Intecc to introduce its Indigo Aspiration System in Japan. With the use of the minimally invasive Indigo Aspiration System, blood flow can be restored as emboli and thrombi are removed from vessels in the peripheral arterial and venous systems and treated for pulmonary embolism. 

Additionally, the minimally invasive device enables blood flow to be restored in conditions like acute limb ischemia and venous thrombosis. In order to assist catheters in removing thrombus from vessels of various sizes, it uses the Penumbra ENGINE aspiration source, which generates a virtually pure, continuous vacuum. According to Penumbra, the partnership will bring together its most recent inventions with Asahi’s leadership and industry knowledge in the Japanese medical device market.

Penumbra president and CEO Adam Elsesser said: “We can provide physicians in Japan with technology that has been proven highly effective, helping patients return home quickly and in good health. This furthers our commitment to advance novel technologies to address unmet needs and improve patient care worldwide.”

Asahi Intecc president and CEO Masahiko Miyata said: “Our companies share a similar mission to help expand the available treatment options for serious conditions that impact an increasing number of people in Japan. We believe that, together, we are able to provide physicians with the latest innovations that best meet their patients’ needs and help advance patient care.”

As per DelveInsight’s “Transcatheter Embolization And Occlusion Devices Market” report, the global Transcatheter Embolization and Occlusion Devices Market were valued at USD 4.04 billion in 2021, growing at a CAGR of 9.14% during the forecast period from 2022 to 2027, to reach USD 6.84 billion by 2027. The demand for Transcatheter Embolization and Occlusion Devices is primarily attributed to the rising technological advancement, surge in the prevalence of chronic diseases like cardiovascular diseases, respiratory disorders, and cancer, highly structured health care industry, increased adoption of minimally invasive surgeries, and increasing geriatric population.

iMediSync’s EEG scanner ‘iSyncWave’ has been FDA 510k cleared

On September 15, 2022, iMediSync, is an AI-based digital mental health care platform company. The company reported that on August 10th United States Food and Drug Administration (FDA) awarded 510k clearance for its medical device EEG scanner.

Dry EEG scanners like iSyncWave don’t need electrode gel to work. Not only is it simple to use the gadget and take EEG readings, but its size can also be changed to fit a variety of head shapes and line up with the globally accepted 10-20 system. Additionally, iSyncWave uses a big data-based autonomous cloud analysis engine to quickly analyze the QEEG (Quantitative Electroencephalogram).

The Public Procurement Service in South Korea recently recognized this device as an inventive prototype product, and Pusan National University Hospital began using it for mobile medical checkups. Leading university hospitals in South Korea, like Seoul National University Hospital and Asan Medical Center, continuously gather data from patients with a range of ailments and illnesses (stroke, Parkinson’s, etc.).

Seungwan Kang, the CEO of iMediSync stated, “After CES 2022 and AAIC (Alzheimer’s Association International Conference), we are receiving many inquiries from the US, Europe, Australia, and other countries, particularly around research and clinical introduction from leading universities and institutions around the world. With FDA 510k clearance, we can provide product information and conduct collaborative research to sell iSyncWave. We are also preparing the CE (EU), TGA (Australia) and PMDA (Japan) registrations for countries that require registration other than from the FDA for import.”

According to DelveInsight’s “Brain Monitoring Devices Market” report, the global Brain Monitoring Devices Market was valued at USD 6.31 billion in 2021, growing at a CAGR of 7.27% during the forecast period from 2022 to 2027, to reach USD 9.61 billion by 2027. The demand for brain monitoring devices is primarily being boosted by the rising prevalence of neurological diseases, technological advancement in product development, rising awareness about neurodegenerative diseases, and increasing brain monitoring applications in clinical trials. The growing demand for minimally invasive devices and the expanded therapeutic applications of brain monitoring devices are further expected to boost the brain monitoring devices market growth.

Zynex Monitoring Solutions Announces First Enrollment in a Blood Loss Detection Clinical Trial for its CM-1600 Monitoring System

On September 21, 2022, Zynex, Inc., is an innovative medical technology company which manufactures and sells non-invasive medical devices for pain management, rehabilitation and patient monitoring, announced that it had started enrollments in a large-scale blood loss detection clinical trial with its second-generation monitoring system, the CM-1600.

The multi-site trial aims to ascertain the specificity and sensitivity of the CM-1600 in detecting minute blood loss during whole blood donation. It was first launched by ClinCept, LLC. in collaboration with LifeSouth Community Blood Center. Throughout the course of the study, Zynex Monitoring Solutions anticipates accumulating more proof in support of the use and application of the CM-1600 throughout the study.

“Clinical trials are vital not only to optimizing the performance of our device but also to building the critical body of evidence clinicians need to gain trust in our patented Relative Index,” said Thomas Sandgaard, CEO, Chairman and Founder.

Donald Gregg, VP of Zynex Monitoring Solutions noted that “Zynex has a robust pipeline of research in our development strategy, and we are excited to kick off this trial to statistically define the sensitivity and specificity of our device.”

According to DelveInsight’s “Patient Monitoring Devices Market” report, the global patient monitoring devices market was valued at USD 35.21 billion in 2021, growing at a CAGR of 8.20% during the forecast period from 2022 to 2027, in order to reach USD 56.46 billion by 2027. The escalating demand for patient monitoring devices is primarily attributed to the increase in the prevalence of various chronic and lifestyle-associated disorders. Moreover, the sudden outbreak of the COVID-19 pandemic has also contributed to the patient monitoring devices market. Additionally, the growing preferences for remote patient monitoring systems among the patient and healthcare providers, increase in technological advancement in the product arena, and rise in the approval of various patient monitoring devices in the current year, among others, are also some of the factors responsible for potentially increasing the global patient monitoring devices market during the forecast period (2022-2027).

Prosoma Digital Therapeutics and EVERSANA Announce Commercialisation Partnership for New Therapeutic Supporting Mental Health and Behavioural Needs of Cancer Patients

On September 26, 2022, Prosoma Digital Therapeutics, innovators in reinventing healthcare for oncology patients, partnered with EVERSANA®, a pioneer of next-generation commercial services to the global life sciences industry, to support the expected launch and commercialization for Prosoma’s digital therapy to support the mental health of cancer patients.

The digital therapy, Living Well, is the company’s proprietary application intended to enhance the quality of life and reduce stress, anxiety, and depression symptoms related to cancer diagnosis and treatment. Prosoma will get assistance from EVERSANA’s top professionals in establishing and commercializing digital therapeutic solutions as it navigates regulatory frameworks and makes commercialization plans.

As we looked to navigate the complexity of commercialising our digital solutions in the United States, it became clear we need a partner with the infrastructure and experience to help us move quickly,” said Andrzej Jonczyk, Chief Executive Officer, Prosoma U.S. “As we spoke with partners across Europe and the world, one name continued to rise to the top and that was EVERSANA. Their integrated platform and deep experience in digital therapeutics make them the perfect partner to help bring our important therapies to patients.”

“The future of healthcare continues to evolve as innovative solutions improve the patient journey,” said Jim Lang, CEO, EVERSANA. “EVERSANA was built with this in mind. By helping Prosoma, we will provide critical mental health support for cancer patients and caregivers through this novel approach to digital therapy.”

According to DelveInsight’s “Telehealth Market” report, the global telehealth market is estimated to grow at a CAGR of 31.57% during the forecast period from 2022 to 2027. The increase in demand for telehealth is primarily attributed to the rise in shifting focus among the population for lowering the healthcare cost and the rise in the government initiatives to launch telemedicine to provide increased access among the patient population. Moreover, the sudden outbreak of the COVID-19 pandemic and the increasing prevalence of chronic disorders will propel the demand for telehealth in the market. Further, the increasing number of diagnostic telehealth platforms, shortage of physicians, and technological advancements are anticipated to bolster the market, thereby contributing to the growth of the telehealth market during the forecast period from 2022-2027.

FDA Grants QT Imaging™ Clearance to Calculate Fibroglandular Volume of the Breast

On September 22, 2022, QT Imaging, Inc, is a privately held firm working to develop and market a cutting-edge automated imaging system that can create transmission ultrasound images with a high level of clarity.  

The company received 510(K) approval from US FDA allows QT Imaging, Inc. to determine the fibroglandular volume (FGV) of the breast and the proportion of FGV to total breast volume (TGV). This ratio can help determine a person’s risk for developing breast cancer, and changes in this ratio can be used to gauge how well a drug works to treat or prevent breast cancer.

Unlike traditional breast imaging modalities, the company’s QTscan™ does not require radiation, injection, or compression and is highly accurate (+ 0.2%), allowing earlier and more frequent monitoring for women receiving non-surgical breast cancer treatments such as adjuvant chemotherapy, radiation therapy, cryotherapy, and hormone or selective hormone receptor modulation treatments. The FDA has not approved any other ultrasound-based breast imaging technique for measuring fibroglandular volume.

“The ability to determine a therapeutic clinical response using a quantitative volumetric method is crucial for effective and timely treatment of breast cancer and for patients at high risk for developing breast cancer who are receiving hormonal therapy. The FGV tool will allow this assessment to be made early and in follow-up to maximize treatment benefit, which is an exciting development for breast care patients,” said Dr. Elaine Iuanow, a Breast Imaging specialist and medical consultant for QT Imaging.

“We are excited to expand the tools available using low frequency transmitted ultrasound volography to serve women, especially those with dense breasts, providing an imaging option that is safe, comfortable, and effective,” said Dr. John Klock, CEO, Chief Medical Officer and Founder of QT Imaging, Inc.

According to DelveInsight’s “Breast Cancer Diagnostics Market” report, the global Breast cancer diagnostics market was valued at USD 4.20 billion in 2021, growing at a CAGR of 6.66% during the forecast period from 2022 to 2027 to reach USD 6.16 billion by 2027. The Breast cancer diagnostics market is witnessing positive growth owing to the factors such as, the increasing prevalence of breast cancer, increasing age and sedentary lifestyle,  technological advancements, and 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.

Reva Medical Announces Initiation of Enrollment in the MOTIV IDE Clinical Trial

On September 27, 2022, REVA Medical, LLC,  a pioneer in bioresorbable polymer
technologies for vascular applications announced that enrollment in the MOTIV pivotal trial had been initiated at clinical centers in both the United States and Europe. The study will evaluate the use of the MOTIV® SirolimusEluting Bioresorbable Vascular Scaffold for treatment in patients suffering from Chronic Limb-Threatening Ischemia (CLTI). CLTI is an advanced stage of Peripheral Artery Disease (PAD), often affecting the Below-The-Knee (BTK) artery bed and linked with impaired quality of life due to a high risk of serious health issues, including amputation, adverse cardiovascular events, and mortality.

The MOTIV study is an international, randomized controlled trial (RCT) that was created to assess the safety and effectiveness of the MOTIV scaffold for the treatment of infrapopliteal lesions in patients with CLTI by comparing it in a blinded fashion to conventional balloon angioplasty. Under the guidance of co-principal investigators Dr. Ehrin Armstrong from Adventist Health in St. Helena, California, and PD Dr. med. Andrej Schmidt from Universitätsklinikum Leipzig, the study will oversee up to 292 participants at around 35 healthcare sites in the United States and Europe. 

MOTIV is a totally bioresorbable sirolimus-eluting scaffold that is created to disintegrate over time, freeing the artery freeing from a permanent implant and, thereby, allowing it to resume its natural movement or vasomotion. MOTIV is made from REVA’s proprietary polymer, Tyrocore®, which was made specifically for scaffold performance. The new features of Tyrocore enhance scaffold strength in a thin-strut design, are intended to improve ease of use, including single-step inflation, and enable visibility of the entire device under fluoroscopy, an attribute unique to MOTIV among bioresorbable scaffolds.

The absence of an approved device as a dedicated treatment option for the estimated 20 million patients1 worldwide suffering from CLTI is a significant unmet need,” commented Dr. Jason Ricci of Bellin Health Cardiology Associates in Green Bay, Wisconsin, and the physician who enrolled the first U.S. patient. “I’m delighted to play a role in this important trial and evaluate its potential to advance the science and therapies available to this highly complex patient population.”

“The initiation of our MOTIV clinical trial is an exciting and important milestone for REVA, as well as the global medical community,” said Jeffrey Anderson, President, and CEO, of REVA Medical, LLC. “We are focused on addressing the need for more durable treatment options for this debilitating disease and committed to finding the best possible therapies to improve patient outcomes.”

According to DelveInsight, the Bioresorbable Vascular Scaffold Market is expected to grow in the coming years owing to the increasing prevalence of cardiovascular disorders, rising geriatric population, rise in technological advancements, and rising prevalence of risk factors such as diabetes as well as obesity.