GE HealthCare Announced Collaboration with DePuy Synthes to Bring Advanced 3D Precision Imaging Innovation to Spine Practices in the United States

On June 21, 2023, GE HealthCare entered into a distribution agreement with DePuy Synthes, the Orthopaedics division of Johnson & Johnson, to bring GE HealthCare’s OEC 3D Imaging System, in conjunction with DePuy Synthes’ extensive product portfolio, to more surgeons and patients across the United States.

The new collaboration demonstrated GE HealthCare’s ongoing commitment to launch exceptional imaging technologies for clinicians providing patient care through the practice of some of healthcare’s most complex spine procedures. 

The spine, which is made up of muscles, bones, tendons, ligaments, and delicate nerves, is a vital component of the human body. Any part of the body can be affected by spinal injuries or deformities, which severely limit mobility and lower quality of life. In the face of such complexity, visualization, and imaging are essential for assisting with accurate diagnosis and treatment to ensure the best possible patient outcome.

With daily spine procedures being performed in surgical suites, GE HealthCare’s OEC 3D Imaging System was created to improve surgical imaging precision and efficiency. The OEC 3D surgical imaging C-arm is a portable CBCT imaging system that provides a wide anatomical field of view while seamlessly enabling intraoperative 3D volumes and 2D high-definition imaging. The OEC 3D C-arm offers clinicians a wider perspective with its accurate 3D volumetric images and well-known OEC 2D imaging capabilities, as well as features for image analysis, noise reduction, inter-operative review, and seamless workflow.

Providers require effective imaging capabilities given the rising demand for minimally invasive surgical procedures and the fact that more than half of all outpatient procedures in the United States are performed in ambulatory surgery centers. This new agreement will make it possible for both businesses to provide surgeons with better services while addressing the complex needs of their patients and a variety of procedural requirements in the spine.

“We know that GE HealthCare’s OEC 3D is a game-changer for clinicians today – from its large field of view and open platform to high-quality reconstructed 3D images. Through this new collaboration with DePuy Synthes, we’re excited for the opportunity to bring this technology to more spine practices in acute to outpatient settings knowing OEC 3D provides precise and efficient imaging so that surgeons can stay focused on what matters most, providing quality patient care”, said Phil Rackliffe, President & CEO for GE Healthcare’s Image-Guided Therapies business.

As per DelveInsight’s Spinal Surgery Devices Market” report, the global spinal surgery devices market is estimated to grow at a CAGR of 5.65% during the forecast period from 2023 to 2028. The spinal surgery devices market is observing remarkable market growth owing to various factors such as the subsequent rise in spinal disorders across the globe, increasing road accidents, and increasing demand for minimally invasive surgical procedures among others. Further, the increasing demand for technologically advanced spinal surgery devices in the market will also spur market growth in the forthcoming years. Additionally, a rise in spending on spinal surgery products along with the increasing product launches and approvals, and other factors will create a requisite for the spinal surgery devices in the market. Therefore, the market for spinal surgery devices is estimated to grow at a substantial CAGR during the forecast period from 2023 to 2028.

Eko Health Launched CORE 500™ Digital Stethoscope with Heart Disease Detection AI, 3-Lead ECG, and Advanced Audio Capabilities

On June 27, 2023, Eko Health, a leading innovator in digital health technology for heart and lung disease detection, announced the launch of its next-generation digital stethoscope, CORE 500™. 

The CORE 500 Digital Stethoscope is the culmination of more than a decade of industry innovation in the field of digital auscultation (hearing the heart, lungs, and other body sounds). The CORE 500 is an essential patient assessment tool for healthcare professionals (HCPs) and it was designed to improve diagnostic accuracy and early disease detection. It combines artificial intelligence (AI) software, high-fidelity audio experience, full-color display, and 3-lead electrocardiogram (ECG).

The CORE 500 is the first stethoscope to offer HCPs precise, immediate patient auscultation data, including heart rate and ECG tracing, on a full-color display. The stethoscope quickly detects abnormalities, such as AFib, bradycardia, and tachycardia, when backed by Eko Health’s FDA-cleared AI products. The CORE 500™ comes with TrueSound™, Eko’s most recent audio innovation, as well as active noise cancellation, three different audio filter modes, and up to 40x sound amplification. TrueSound™ offers superior sound filtering and reduced background noise with in-ear speaker technology to deliver the most accurate sound during each patient exam. 

CORE 500™ is designed for use across clinical specialties, including structural heart, primary care, urgent care, emergency medicine, home care, and virtual care. It has the familiar design and simple workflow of a conventional stethoscope. The CORE 500™ is made of lightweight shatter, splash, and scratch-resistant material and is designed for dependability. With a lithium-ion fast-charging battery that can run continuously for up to 60 hours in a clinical setting, it is designed for multiple shifts.

“The CORE 500™ represents a major leap forward in digital stethoscope technology. When paired with our powerful AI algorithms, it can help detect leading indicators of heart disease in seconds, greatly assisting healthcare professionals in identifying various cardiac conditions with increased accuracy and confidence. This innovative feature aims to save time during routine exams and improve patient outcomes.” said Connor Landgraf, Co-founder & CEO of Eko Health.

“As cardiovascular disease rises with our aging population, non-invasive tools like the CORE 500™ turn a patient interaction into a potential disease screening,” said Paul Friedman, M.D., Chair of Cardiovascular Medicine at Mayo Clinic in Rochester, Minnesota. “The Mayo Foundation for Medical Education and Research has a financial interest in Eko Health. Supported AI diagnostics software, advanced audio technology, and 3-lead ECG make this a useful tool for clinicians. The live ECG tracing on display will help identify patients with previously unknown arrhythmias at the point of care.”

According to DelveInsight’s Stethoscope Market” report, the global stethoscope market is estimated to grow at a CAGR of 5.3% during the forecast period from 2023 to 2028. The demand for stethoscopes is primarily being boosted by the increasing number of average patient visits to physicians owing to the rising prevalence of chronic diseases such as cardiovascular diseases, respiratory illnesses such as asthma, bronchitis, and lifestyle disorders such as hypertension, diabetes, obesity, and others. Further, the increasing geriatric population, the rising demand for an electronic stethoscope, various product approval & launches, innovation in product development, and others are contributing to the overall growth of the stethoscope market during the forecast period from 2023-2028.

Haemonetics Received FDA Clearance for Enhancements to NexSys PCS® Plasma Collection System

On June 22, 2023, Haemonetics Corporation, a global medical technology company focused on delivering innovative solutions to drive better patient outcomes, announced that the US FDA had approved improvements to its NexSys PCS® plasma collection system. These include new Express® Plus Technology designed to speed up procedures and a new plasma collection bowl with a patented design that optimizes performance.

With more than 50 million actual plasma collections performed to date on NexSys PCS, the market’s most cutting-edge, fully integrated system created to streamline plasma collections and improve yield, productivity, safety, quality, compliance, and donor satisfaction, Haemonetics is the market leader in plasma collections. 

With the most recent developments, Haemonetics anticipates an average procedure time of 33 to 38 minutes using the typical FDA nomogram, assisting customers in achieving new levels of plasma center efficiency and reducing collection costs.

Donor door-to-door time has already been reduced by 16 minutes on average owing to the bi-directionally connected NexSys PCS and NexLynk DMS® donor management software, with a sizable portion of this improvement occurring before and after the procedure. Additionally, by tailoring each collection to the unique donor characteristics, NexSys PCS with Persona® Technology safely delivers an additional 9% to 12% plasma yield on average. 

In the upcoming months, Haemonetics intends to launch NexSys PCS on the market for the first time with the new bowl and Express Plus Technology.

“Haemonetics sets the standard in global plasma collection solutions that meet collectors’ most critical needs. With our redesigned bowl and new Express Plus Technology for faster procedure times and enhanced plasma center efficiency, we continue to advance our innovation to lead the industry in reducing cost per liter for collectors and ensuring the best experience for their donors,” said Roy Galvin, President, Global Plasma and Blood Center at Haemonetics.

According to DelveInsight’s “Blood Collection Devices Market” report, the global blood collection devices market was valued at USD 6.23 billion in 2022, growing at a CAGR of 6.85% during the forecast period from 2023 to 2028 to reach USD 9.25 billion by 2028. The blood collection devices market is slated to witness prosperity owing to factors such as an increase in diagnostic tests owing to the growing prevalence of infectious diseases such as COVID-19, malaria, and others, increasing awareness over health, a rise in blood transfusion procedures, and the growing focus on improving the safety and usability of blood collection devices for end users are further expected to result in the appreciable revenue growth in the blood collection devices market during the forecast period (2023-2028).

Roche Received FDA Clearance for Additional Alzheimer’s Disease Cerebrospinal Fluid (CSF) Assays

On June 27, 2023, Roche declared that the FDA’s 510(k) clearance has been granted for its Elecsys® beta-Amyloid (1-42) CSF II (Abeta42) and Elecsys® Total-Tau CSF assays (tTau). The beta-amyloid and tau proteins, two biomarkers of Alzheimer’s pathology, are measured by the Elecsys AD CSF Abeta42 and tTau assays (used as a tTau/Abeta42 ratio) in adults 55 years of age and older who are being assessed for the disease.

Currently, the diagnosis of Alzheimer’s is made primarily by exclusion (ruling out non-Alzheimer’s causes of symptoms), and it is based on several evaluations, including different cognitive tests, common laboratory tests, and neuroimaging with a head MRI or CT scan. A clinical diagnosis is only made 70%–80% of the time, and getting an accurate diagnosis can take years. Additional assessments using Alzheimer’s-specific biomarkers help doctors make better choices because they can spot underlying pathological changes before symptoms appear.

In the United States, Roche offers two ratios that combine into three assays for its FDA-approved Alzheimer’s tests. Abeta42 is present in both ratios. The Elecsys® beta-Amyloid (1-42) CSF II (Abeta42) and Elecsys® Phospho-Tau (181P) CSF (pTau181) assays (used as a pTau181/Abeta42 ratio) that received FDA 510(k) clearance in 2022 and Elecsys beta-Amyloid (1-42) CSF II and Elecsys Total-Tau CSF assays (the tTau/Abeta42 ratio) are reflective of the main Alzheimer’s pathologies and help clinicians more completely define the disease biologically, facilitating a diagnosis of inclusion.

Elecsys’ AD CSF assays can confirm the presence of amyloid pathology in the brain and are compatible with amyloid PET scan imaging, which may make them a more practical and accessible routine option. They also provide radiation-free detection of both the amyloid and tau biomarkers from a single draw, with the potential to identify the pathology associated with Alzheimer’s disease in its early stages. The use and accessibility of PET are restricted by its high price, scarcity, and patient radioactivity exposure. Additionally, using PET to assess both the amyloid and tau Alzheimer’s biomarkers necessitates numerous appointments and procedures, which raises radiation exposure. 

“With the increasing likelihood of broad availability of new, Alzheimer’s disease–specific therapies, now is the time for healthcare professionals and institutions to prepare to meet the demand for diagnostic methods to streamline and accelerate the path to the right treatment, at the right time, for people with Alzheimer’s,” said Brad Moore, president, and CEO of Roche Diagnostics North America. Brad Moore added, “An early and accurate diagnosis can help patients, caregivers, and physicians determine a path forward, and the Elecsys CSF assays support diagnosis at early disease stages when treatment is most effective.”

According to DelveInsight’s “Alzheimer’s Disease Diagnostic Market” report, the global Alzheimer’s disease (AD) diagnostic market will grow at a CAGR of 10.97% during the forecast period from 2023 to 2028. The Alzheimer’s disease (AD) diagnostic market is observing optimistic market growth due to a rise in regulatory approvals for Alzheimer’s disease (AD) diagnostics across the globe. Further, the rising prevalence of head injuries owing to accidents, workplace injuries, and others, and the rise in the geriatric population will increase the prevalence of Alzheimer’s disease, thereby increasing the demand for Alzheimer’s disease diagnostic devices across the globe. Additionally, the increasing research and development of novel biomarkers, presence of key players in the market, increasing product launches and approvals, and others will create a requisite for Alzheimer’s disease diagnostics in the upcoming years. Therefore, the market for Alzheimer’s disease (AD) diagnostics is estimated to grow at a substantial CAGR during the forecast period from 2023 to 2028.

Medtronic Displayed New Data on MiniMed™ 780G system on Fixed Meal Dosing and Real-World Time in Range Across Wide Variety of Users

On June 23, 2023, Medtronic plc, a global leader in healthcare technology, presented a robust collection of new clinical and real-world data on the MiniMed™ 780G system. These most recent data sets showed that the Meal Detection™ technology supported Time in a Range of outcomes that exceeded consensus recommendations of 70%. 

These users included historically difficult younger patients, people who weren’t meeting their glycemic goals, and people who used a simplified meal announcement that used fixed carbohydrate amounts rather than exact carb calculations. The system also aids in lowering the percentage of time that both adults and children spend with hyperglycemia.

The MiniMed™ 780G system was used in the first study by Dr. Goran Petrovski, MD, Ph.D., of Sidra Medicine to randomly divide adolescents (n=34) into two groups, some of whom entered a predetermined fixed number of carbs (small, average, or high), and some of whom calculated a precise number of carbs for their meals. Before the study, these participants used multiple daily injections or pump therapy and had diabetes for at least a year. 

The study’s findings revealed that those who used the simplified (i.e., fixed) carb entry maintained international targets for glycemic control, such as an A1c of 6.9% and Time in Range (TIR) of 72.7% (vs. 79.4% TIR in the precise entry group) over 6 months without system modification.

When using the MiniMed™ 780G system with the recommended settings of 100 mg/dL and a 2-hour active insulin time, children under the age of 15 in Europe and Latin America (n=3,543) had a Time in the Range of 78%. Regardless of baseline glycemic control, SmartGuard™ technology improved glycemic performance in a separate analysis of real-world data from children under 15 in Europe (n=2,516).

Before the introduction of SmartGuard™ technology, the group with the worst glycemic control experienced the largest increase in Time in Range, increasing by 23.3%, while patients with the best metabolic control saw their Time in Range increase by 80.6%. The fact that fewer user-initiated boluses were required to see this increase in Time also indicates a lower patient burden.

“Many individuals with type 1 diabetes struggle with meal management, with nearly 50% considering carb counting the most burdensome aspect of diabetes management.2 Indeed, many frequently underestimate their carbs or forget to bolus, and this has an adverse impact on clinical outcomes,” said Dr. Petrovski. Dr. further said, “This study shows that a simplified meal management approach with the MiniMed™ 780G system helped users maintain glycemic targets while providing forgiveness for inexact carb counts. Clearly, there’s more runway for simplification of diabetes management with this system, and it’s promising for the many patients struggling with meal management.”

“We’re committed to pushing simplification of diabetes management as far as we can and are heartened to see the impact our MiniMed™ 780G system is having on both clinical and quality of life outcomes as evidenced by our randomized controlled ADAPT study and the growing body of real-world evidence from around the world,” said Que Dallara, EVP and President of Medtronic Diabetes. Que Dallara added, “With each advancement, we’re working to reduce more of the burden that this disease demands and will continue to innovate to make life easier for those we have the privilege to support.”

According to DelveInsight’s “Insulin Delivery Devices Market” report, the global Insulin Delivery Devices Market was valued at USD 15.51 billion in 2022, growing at a CAGR of 9.28% during the forecast period from 2023 to 2028, to reach USD 26.35 billion by 2028. The rise in demand for insulin delivery devices is predominantly attributed to the rising prevalence of diabetes among the geriatric population, favorable reimbursement scenarios, rising awareness about proper diabetes management and insulin delivery devices, and technological advancement in the product line, among others.

Biodesix Completed Enrollment of INSIGHT Study Assessing Clinical Utility of the VeriStrat® Blood-Based Host Immune Classifier

On June 27, 2023, Biodesix, Inc., a leading data-driven diagnostic solutions company with a focus in lung disease, announced that 5,000 patients with non-small cell lung cancer (NSCLC) had been enrolled in the significant multi-center observational registry study INSIGHT (Clinical Effectiveness Assessment of VeriStrat® Testing and Validation of Immunotherapy Tests in NSCLC Subjects). 

The goal of the study was to further validate the efficacy of the VeriStrat® test, a new blood-based host immune classifier with predictive and prognostic capabilities, and its capacity to support therapeutic decisions for patients with NSCLC using various therapeutic modalities.

The VeriStrat test stratifies immune checkpoint inhibition (ICI) treatment response in patients with advanced NSCLC, according to findings from earlier analyses of the INSIGHT study. This data showed that, regardless of PD-L1 status, patients with Host Immune Classifier Cold (HIC-C), also known as VeriStrat Poor, had a higher median overall survival when receiving ICI plus chemotherapy than when receiving ICI alone.

“The INSIGHT study gives us a unique opportunity to examine real-world treatment patterns for lung cancer, the deadliest of all cancers, in the context of patient’s immune response,” said Dr. James Jett, co-Chief Medical Officer at Biodesix. Dr. James also commented, “Five-year survival for patients with non-small cell lung cancer is approximately 25 percent, but now we are seeing that with the use of this proteomic test, we can identify treatment options, particularly those utilizing Immune Checkpoint Inhibitors in addition to standard chemotherapy, that may extend overall survival in select groups of patients.”

According to DelveInsight’s “Cancer Diagnostics Market” report, the global cancer diagnostics market was valued at USD 125.13 billion in 2022, growing at a CAGR of 9.43% during the forecast period from 2023 to 2028, to reach USD 214.88 billion by 2028. The increase in demand for cancer diagnostics products and services is predominantly attributed to the spike in cancer cases reported worldwide. In addition, the growing manufacturers’ focus to develop advanced cancer diagnostic products, the establishment of various cancer diagnostic labs, and rising government initiatives to raise awareness regarding early detection and management of cancer among patients, and others are anticipated to drive the global cancer diagnostics market during the forthcoming years.