Savara Introduced aPAP ClearPathTM to detect Autoimmune Pulmonary Alveolar Proteinosis 

On December 21, 2023, Savara, a clinical stage biopharmaceutical company launched aPAP ClearPathTM, which is used by the physicians to obtain a conclusive diagnosis of Autoimmune Pulmonary Alveolar Proteinosis (aPAP), a rare autoimmune lung disease characterized by abnormal accumulation of surfactant sediment in the lung’s alveoli or air sacs.  

The aPAP ClearPathTM is a quantitative immunoassay test with excellent sensitivity and specificity, which is intended to identify aPAP GM-CSF autoantibodies in human serum. 

Savara collaborated with Trillium Health, a Clinical Laboratory Improvement Amendments (CLIA)-certified lab (CLIA) in order to create a straightforward, cost effective, and non-invasive test. Further, an awareness campaign was also launched in order to raise awareness and understanding of aPAP, highlighting the key signs and symptoms of the disease, and to guide medical practitioners regarding the importance for early testing.

Our strong operational focus continues as we deliver on our goal of introducing a laboratory-based GM-CSF autoantibody blood test in the U.S. by the end of the year,” said Matt Pauls, Chair and CEO, Savara. “Our commitment to the patient community is underscored by the introduction of this simple, no-cost blood test that U.S. physicians can use to confirm or rule out aPAP. With a few thousand diagnosed patients in the U.S., we suspect the true prevalence of aPAP may be underestimated and, similar to other rare diseases, the introduction of a diagnostic could help decrease the time to diagnosis and increase diagnosed prevalence.”

“Education and widespread blood testing for aPAP is a critical step in shortening the time to diagnosis for patients with aPAP, helping to avoid misdiagnoses and more costly and invasive diagnostic procedures,” said Ali Ataya, M.D., Associate Professor of Medicine, University of Florida, Division of Pulmonary and Critical Care Medicine. “I congratulate Savara for making this simple test broadly available for physicians in the U.S.” 

As per DelveInsight’s “Autoimmune Diseases Diagnostics Market” report, the global Autoimmune Disease Diagnostics Market is estimated to grow at a CAGR of 5.53% during the forecast period from 2023 to 2028 to reach USD 6.41 billion by 2028. The demand for diagnosis of autoimmune diseases is primarily being boosted by the increasing number of cases of autoimmune disorders such as Rheumatoid ArthritisType I Diabetes, and Addison’s disease among others. Additionally, the rising awareness among people regarding early disease diagnosis and the rising technological advancements in the healthcare domain, are also contributing to the growth of the Autoimmune Diagnostics Market during the forecast period from 2023-2028.

RaySearch Released RayStation 2024A

On December 22, 2023, RaySearch Laboratories AB launched RayStation® 2024A, the most recent version of the comprehensive treatment planning system introduced by the company. The recent edition includes several new improvements and modifications required for important clinical workflows. 

The RayStation 2024A offers a single control center for all treatment planning requirements, supporting a broad variety of treatment needs. The updated treatment planning system provides the option to select fixation and support devices per plan and sub-plan, which further helps in adding enhanced flexibility when combined treatment plans are made for patients. Additionally, RayStation 2024A improves the system’s connection with RayIntelligence, an analytics platform for cancer. Users may track and comprehend the clinic’s present condition and treatments with RayIntelligence’s automatic absorption of RayStation data. RayIntelligence is also capable of offering insights on future ways in order to increase treatment quality and efficiency.

Johan Löf, founder and CEO, RaySearch, said,Further enhancing the capabilities of multi-modality treatments is key for RaySearch in the ambition to provide tools to create the best treatment plans for cancer patients. With RayStation 2024A we also continue with improvements within fast adaptive re-planning, which will be an important focus area during the coming years.”

According to DelveInsight’s “Clinical Decision Support Systems Market” report, the global clinical decision support systems (CDDS) market was valued at USD 2.23 billion in 2022, growing at a CAGR of 6.62% during the forecast period from 2023 to 2028 to reach USD 3.28 billion by 2028. The increase in demand for clinical decision support systems is primarily attributed to the increasing pool of patients due to the increasing prevalence of chronic disorders and due to unhealthy lifestyles and habits. 

Moreover, the surging need by patients for improvement in the quality of patient care will bolster the market of the clinical decision systems in the study period. Furthermore, the growing demand for intelligent software solutions in the healthcare sector globally will increase the demand for CDDS. Additionally, the CDDS may provide remote patient care which will decrease the number of hospitalizations of patients, thereby reducing the overall healthcare expenditure. Thus, the need to reduce healthcare expenditure across the world is anticipated to bolster the market, thereby contributing to the growth of the clinical decision support systems market during the forecast period from 2023-2028.

FDA Approved Expanded Label for CVRx Neuromod Tech

On December 26, 2023, CRVx announced that it received approval from the U.S. Food and Drug Administration (FDA) for its Barostim neuromodulation system. 

Barotism neuromodulator system developed by CRVx is employed to provide electrical pulses to the carotid artery wall’s baroreceptors. The electrical pulses generated by the neuromodulator system activates body’s baroreflex, which in turn triggers an autonomic response to the heart. The company designed the therapy with an aim to restore the balance of autonomic nervous system, and thus decreasing the symptoms of heart failure. 

The U.S. Food and Drug Administration (FDA) approved the system as a breakthrough device and granted permission for use in treating heart failure patients in the United States. Additionally, the device had received CE mark approval in Europe for the treatment of resistant hypertension and heart failure.

“We are very pleased to receive this important validation from FDA of the long-term results of the post-market phase of the BeAT-HF clinical trial and excited we can now share this data with physicians and patients,” said Nadim Yared, president and CEO of CVRx. “We remain grateful to all patients, investigators, research teams, the executive steering committee and FDA personnel, for supporting our efforts to conduct this landmark study over seven years, including the difficulties encountered during the COVID-19 pandemic.”

According to DelveInsight’s “Neuromodulation Devices Market“, report, the global neuromodulation devices market was valued at USD 5.71 billion in 2022, growing at a CAGR of 8.95% during the forecast period from 2023 to 2028, to reach USD 9.56 billion by 2028. The demand for neuromodulation devices is primarily motivated by the increasing prevalence of neurological disorders coupled with the rising aging population, expansion of the devices to other chronic indications and target applications, technological advancement in the product portfolio, rising government initiatives to raise awareness among patient regarding neurological disorders, among others.

Masimo Received US FDA Clearance for Baby Monitoring System

On December 19, 2023, Masimo, a global medical technology company that is engaged in the development and manufacturing of innovative non-invasive patient monitoring technologies and medical devices announced that it received US FDA clearance for its baby monitoring system named Stork.

The baby monitoring system Stork, is meant to be prescribed for use with healthy and unwell infants between the ages of 0 and 8 months. Additionally, the device can be utilized as a medical instrument in order to keep an eye on infants at home.

Stork is available at stores across the country as a non-medical device for general health and wellness needs. It leverages Masimo’s Signal Extraction Technology (SET), which is used to continuously and accurately monitor the health of over ten million newborns in hospitals each year. Additionally, with the use of Stork parents and family members can now receive information about their baby’s skin temperature, oxygen saturation (SpO₂), and pulse rate (PR) upon prescription. Further, clinicians can access the vital sign data of infants remotely.

According to DelveInsight’s “Patient Monitoring Devices Market” report, the global patient monitoring devices market was valued at USD 35.21 billion in 2022, growing at a CAGR of 8.20% during the forecast period from 2023 to 2028, in order to reach USD 56.46 billion by 2028. 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 patients and healthcare providers, the increase in technological advancement in the product arena, and the 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 (2023-2028).

Kansas City Proton Institute Initiated Cancer Treatments With Advanced MEVION S250i Proton Therapy System    

On December 22, 2023, Kansas City Proton Institute (KCPI) and Mevion Medical Systems announced the treatment of the first four patients with the MEVION S250i Proton Therapy System®. The Kansas City Proton Institute recently established its new facility that consists of the region’s first Mevion compact proton therapy system. The newly constructed KCPI facility is 34,000 square feet and has two floors, a partially finished basement, and enough of parking for patient convenience. 

The MEVION S250i system integrates a cutting-edge advanced 3D imaging system and will install the C-RAD Catalyst PT surface-guided tracking system, enabling an image-guided proton therapy configuration for high-precision patient positioning and intra-fraction motion management. 

The KCPI also consists of Mevion’s HYPERSCAN® pencil beam scanning technology. Both devices are capable of delivering great options for treating tumors close to delicate body parts like the head and neck, spinal cord, breasts, oesophagus, prostate, lung, bone, stomach, colon, and bladder because of its ability to deliver therapeutic doses of radiation to tumors more quickly and precisely while protecting surrounding healthy tissue and organs at risk.

We know patients have choices when it comes to cancer care, and when they choose KCPI, we want them to know they have access to the best treatments, convenient care, and knowledgeable staff,” said Dr. James Coster, radiation oncologist for Kansas City Proton Institute. “KCPI is committed to providing the most advanced form of radiation therapy in an outpatient facility making proton therapy accessible and for all patients.”

We congratulate Kansas City Proton Institute for starting treatment with the Mevion proton therapy system,” said Tina Yu, PhD, chief executive officer and president of Mevion Medical Systems. “Mevion is proud to be a part of KCPI’s dedication to offering this state-of-the-art cancer treatment in Kansas City and the surrounding area.”

According to DelveInsight’s “Radiotherapy or Radiation Oncology Devices Market” report, the global radiotherapy/radiation oncology devices market is projected to grow at a 7.78% CAGR during the forecast period (2023-2028). The Radiotherapy/Radiation Oncology Devices market is witnessing positive growth owing to factors such as the rising cases of various cancers, further rapid technological developmental activities, strong R&D initiatives from key players, rising adoption of radiotherapy procedures in cancer treatment, growing demand for minimally invasive procedures, thereby contributing to the growth of the Radiotherapy/Radiation Oncology Devices market during the forecast period from 2023-2028.

Gore Announced First Patient Implant in the Arise II Pivotal Study of the Gore® Ascending Stent Graft

On December 20, 2023, W. L. Gore & Associates announced the implementation of the first implantation of GORE® Ascending Stent Graft in the ongoing ARISE II Trial, a promising advancement in the development of treatment related to ascending aorta. 

The ARISE II Study is the first multicenter pivotal trial examining the use of a minimally invasive endovascular device to treat the ascending aorta and is approved by the U.S. Food and Drug Administration (FDA). The clinical study examines the treatment of isolated lesions and chronic and persistent Type A dissections. Additionally, as a potential substitute for open surgical treatment, the ARISE II Study will examine the use of an endovascular stent graft administered via a catheter in order to line the damaged section of the ascending aorta. Endovascular technologies have been deployed to other areas of the aorta to lower the risk of problems and recovery durations, however, no endovascular device is currently approved for the ascending aorta.

“The treatment of the ascending aorta has long been a ‘final frontier’ in endovascular surgery. ARISE II is a significant step forward as we search for minimally invasive options that can be offered to higher risk patients,” said Eric Roselli, M.D., national principal investigator and Chief of Adult Cardiac Surgery at Cleveland Clinic.

“Our patient is recovering well. Having a minimally invasive alternative would be a significant advancement for patients not suitable for open surgery,” said Frank Caputo, M.D., vascular surgery director of the Aorta Center at Cleveland Clinic.

According to DelveInsight’s “Stents Market” report, the global stents market is estimated to grow at a CAGR of 5.61% during the forecast period from 2023 to 2028. The stents market is witnessing positive growth owing to factors such as the increasing prevalence of chronic diseases, rise in the geriatric population, increasing demand for minimally invasive procedures, and increase in unhealthy lifestyles, thereby all factors contributing to the growth of the stents market during the forecast period from 2023-2028.