“The Affera system was designed to address procedural challenges faced by the electrophysiology community while maintaining a high standard of safety and efficacy for patients. By enabling a single transeptal, zero-fluoroscopy, and zero-exchange workflow, the Sphere-9 catheter uniquely integrates both mapping and ablation technologies, offering the flexibility to use either pulsed field or radiofrequency energy,” said Doron Harlev, vice president of engineering for Cardiac Ablation Solutions at Medtronic and founder of Affera. “This marks an exciting milestone for the field, with Medtronic’s robust innovation pipeline poised to drive continued progress.”
With this milestone, Medtronic becomes the first company to offer two PFA technologies for AFib patients. The recently approved Affera Sphere-9 catheter offers enhanced procedural flexibility, featuring a unique 9mm lattice tip design compatible with an 8.5Fr sheath, and a wide area focal design for precise, targeted treatment. This joins Medtronic’s existing PulseSelect™ Pulsed Field Ablation System, delivering a secure, single-shot option for pulmonary vein isolation (PVI), offering physicians an unparalleled range of tools for tailored patient care.
As per DelveInsight’s “Cardiac Ablation Devices Market Report,” the global cardiac ablation devices market was valued at USD 2.25 billion in 2023, growing at a CAGR of 12.77% during the forecast period from 2024 to 2030, to reach USD 4.63 billion by 2030. The demand for cardiac ablation devices is motivated by a rise in the prevalence of cardiovascular diseases like cardiac arrhythmia, atrial fibrillation, and stroke. Additionally, minimally invasive procedures like cardiac ablation are gaining traction due to their advantages over traditional open-heart surgeries. Patients prefer these procedures because they offer shorter recovery times, reduced hospital stays, and lower risks of complications such as infection and bleeding. Furthermore, the growing awareness about cardiac arrhythmias and advancements in diagnostic technologies have led to earlier detection through screening programs. As awareness increases among patients and healthcare providers alike, there is a corresponding rise in the number of cases diagnosed and treated. This trend not only expands the market for cardiac ablation devices but also supports timely intervention and better management of cardiac conditions, improving overall patient outcomes during the forecast period from 2024 to 2030.
Precision Optics Customer Received FDA 510(k) Clearance; Accelerating Production Order for POC Single-Use Endoscope Imaging Assembly
On October 29, 2024, Precision Optics Corporation, Inc., a leader in advanced optical instrument design and manufacturing for the medical and defense sectors, announced that its client, a surgical robotics company specializing in transformative urology solutions, received FDA 510(k) clearance for its next-generation AI-powered platform aimed at treating Benign Prostate Hyperplasia (BPH). Precision Optics designed and currently manufactures the single-use endoscope imaging assembly integral to the newly cleared system, showcasing the company’s expertise in high-quality imaging solutions that enhance surgical robotics innovations.
“We are excited by the news and congratulate our customer’s entire team on receiving FDA 510(k) clearance for their revolutionary robotic surgery system,” stated Dr. Joe Forkey, CEO of Precision Optics. “We are proud to have partnered with our customer in the development of the single-use imaging assembly for this system, which required the use of our unique micro-optics and digital imaging technologies to meet the challenging technical requirements within the critical reimbursement constraints for single-use medical devices. We are grateful for the strong partnership between our technical and production teams which led to our customer reaching the commercialization stage on an accelerated timetable. We are pleased to have already completed deliveries for clinical use.”
“Like our customer, POC is optimistic the market for treatment of Benign Prostate Hyperplasia, which is already a large market, will continue robust growth. Our customer has been very successful already in addressing this market with their AI-drive robotic platform, and we expect over the long-term our business may grow several fold as their success continues.”
As per DelveInsight’s “Surgical Robotic Systems Market Report”, the global surgical robotic systems market was valued at USD 5.02 billion in 2023, growing at a CAGR of 11.50% during the forecast period from 2024 to 2030 to reach USD 9.64 billion by 2030. The demand for surgical robotic systems is witnessing a surge due to increasing surgical procedures which can be attributed to various factors such as increasing geriatric population who form a big part of at-risk population for prostate cancer, valvular diseases, endometriosis among other diseases, growing need for robot-assisted surgery systems due to the growing inclination towards minimally invasive surgical approaches, and the innovation in product development which is paving the way for miniaturized surgical robots ultimately contributing in the overall growth of the Surgical Robotic Systems market during the forecast period from 2024 to 2030.
Abbott Initiated New Clinical Trial to Improve Outcomes in Patients with Advanced Heart Failure
On October 24, 2024, Abbott Laboratories, initiated the TEAM-HF trial, a groundbreaking global study aimed at improving outcomes for patients with worsening heart failure who may benefit from advanced therapeutic interventions.
This first-of-its-kind trial plans to enroll up to 850 patients across 75 sites worldwide and will utilize Abbott’s CardioMEMS™ HF System to monitor pulmonary artery pressures (PAP). By leveraging real-time PAP data, the trial seeks to objectively identify high-risk advanced heart failure patients who may benefit from early intervention with the HeartMate 3™ left ventricular assist device (LVAD), potentially delivering life-saving therapy earlier in the disease progression.
The TEAM-HF clinical trial by Abbott introduces an innovative approach to evaluate the benefits of earlier intervention for patients with worsening heart failure. Investigators will leverage pulmonary artery pressure (PAP) data collected via Abbott’s CardioMEMS™ HF System, which uses a sensor placed in the pulmonary artery through a minimally invasive outpatient procedure to track pressure changes over time. For patients whose PAP levels do not decrease with guideline-directed medical therapy, the trial aims to demonstrate the benefits of advanced therapies. These patients will be randomized to either receive the HeartMate 3™ left ventricular assist device (LVAD) implant or continue with their current heart failure medications. Patients whose PAP levels improve under existing medications will join a single-arm registry, where their management will be guided by ongoing data from their CardioMEMS sensor.
“The goal of the TEAM-HF trial is simple in concept but critical to the future care of patients. We want to break down patient care silos, offering a unified effort to not only improve the diagnosis of advanced heart failure, but also enable rapid access to life saving heart pumps. This study aims to take the guess work out of deciding when a patient has reached the ideal time for LVAD implementation,” said Jennifer Cowger, M.D., medical director of mechanical circulatory support and section head of the advanced heart failure program at Detroit-based Henry Ford Health, and one of the national co-principal investigators for the TEAM-HF trial. “Too many patients are not receiving timely access to this life-saving therapy and are needlessly dying of heart failure. The importance of patient access to multidisciplinary heart failure care is embodied in the trial acronym – TEAM-HF – and we feel this study will be instrumental in helping providers identify patients who may benefit from a heart pump earlier in their care journey.”
“As the only healthcare company in the world that has developed medical devices designed to treat people at each stage of heart failure, our hope is that the TEAM-HF study will revolutionize care management for these patients and their families. Getting people on a heart pump more quickly could mean more time spent out of the hospital and with loved ones,” said Keith Boettiger, vice president, Abbott’s heart failure business. “By having more objective methods to accurately gauge heart failure progression and refer people to receive this life-saving therapy faster, healthcare experts will be able to provide patients with improved survival rates and quality of life based on the anticipated results of the TEAM-HF study.”
The first-of-its-kind TEAM-HF study by Abbott is designed to improve clinical outcomes in patients with worsening heart failure by establishing new, objective criteria to identify those at highest risk for progressing to end-stage heart failure. This approach aims to enable life-saving therapeutic interventions earlier in the disease progression, offering patients improved management options and a better prognosis.
According to DelveInsight’s “Cardiac Monitoring Devices Market Report”, the global cardiac monitoring device market is estimated to grow at a CAGR of 5.4% during the forecast period from 2024 to 2030. The cardiac monitoring device market is observing substantial market growth primarily owing to the increasing cases of chronic disorders such as cardiovascular diseases including atrial fibrillation and coronary artery disease (CAD) with the rising shift towards minimally invasive approaches, innovative product developmental activities by leading companies, and rising geriatric population are expected to escalate the overall growth of the cardiac monitoring devices market during the forecast period from 2024 to 2030.
Fresenius Medical Care Recent Study Validated Innovative Anemia Therapy Software That Improved Clinical Outcomes for Hemodialysis Patients
On October 24, 2024, Fresenius Medical Care, the global leader in renal care products and services, revealed innovative findings from a multicenter, randomized controlled trial in the United States, showcasing the potential of personalized anemia therapy for hemodialysis patients. The study demonstrated that patients using anemia therapy assistance software experienced improved hemoglobin stability and reduced reliance on erythropoiesis-stimulating agents (ESAs), highlighting significant benefits for personalized treatment in hemodialysis care.
In a groundbreaking study led by Dr. Doris H. Fuertinger, Fresenius Medical Care examined the effects of personalized anemia treatment on hemodialysis patients across five Fresenius Kidney Care clinics in the United States. The study enrolled 96 patients, randomized into two groups: one receiving individualized treatment recommendations via anemia therapy software, and the other adhering to standard protocols. Over 26 weeks, patients in the personalized therapy group achieved notable benefits, including greater hemoglobin stability, fewer fluctuations, and a 25% reduction in the average dose of erythropoiesis-stimulating agents (ESAs). Key findings indicate significantly lower hemoglobin variability in the personalized therapy group, leading to more consistent and stable patient outcomes.
“This study exemplifies how data-driven insights can lead to more personalized treatments,” said Dr. Frank Maddux, MD, Chief Global Medical Officer of Fresenius Medical Care. “By integrating cuttingedge computational techniques, we are paving the way for more precise, patient-centered care, which not only improves clinical outcomes but also enhances quality of life for people on dialysis. Our commitment is to continue developing innovative solutions that transform kidney care worldwide.”
“This prospective, randomized controlled study highlights the value of physiological models and computer-aided individualization of therapy to improve clinical outcomes for people on dialysis,” said Dr. Fuertinger, Head of Computational Medicine, Fresenius Medical Care. “By harnessing the power of these technologies, we are able to provide clinicians with actionable insights that may enable more precise and efficient therapy management.”
The study highlighted Fresenius Medical Care’s commitment to transforming renal care by developing cloud-based technologies and predictive analytics that can seamlessly integrate into daily clinical practice. As the healthcare landscape shifts toward greater personalization, the company is dedicated to leveraging these advanced tools to optimize patient care. By supporting clinicians in making data-driven decisions, Fresenius Medical Care aims to enhance treatment outcomes and improve the overall quality of care for individuals with renal diseases.
According to DelveInsight’s “Hemodialysis Machines Market Report”, the global hemodialysis machines market was valued at USD 13.53 billion in 2023, growing at a CAGR of 4.71% during the forecast period from 2024 to 2030 to reach USD 17.78 billion by 2030. The increase in demand for Hemodialysis Machines is primarily attributed to the increasing prevalence of kidney disorders such as end-stage kidney disorder, kidney failure, and others. In addition constantly increasing old population, high blood pressure, and high diabetes prevalence is also driving factors for Hemodialysis Machines as old age and diabetic people are more likely to develop kidney disorders. Moreover, technological advancement in the Hemodialysis Machines product pipeline and an increase in product approvals are among the other factors responsible for the growth of the global hemodialysis machines market during the forecast period from 2024 to 2030.
Inspira™ Announced Establishment of Distribution Facility to Support U.S. Deployment of INSPIRA™ ART100
On October 24, 2024, Inspira Technologies OXY B.H.N. Ltd., an innovative life support technology company, is excited to announce a strategic partnership with Glo-Med Networks Inc., which will act as the primary distributor for Inspira’s products in the United States. Glo-Med’s distribution facility will function as a support center for the deployment of the INSPIRA ART100, a device that received U.S. Food and Drug Administration (FDA) 510(k) clearance for use in Cardiopulmonary Bypass (CPB) procedures. This collaboration aims to enhance the availability and support of Inspira’s cutting-edge technology in the U.S. healthcare market.
Inspira Technologies is committed to revolutionizing life support for millions of patients experiencing acute respiratory failure each year. The company’s proprietary INSPIRA™ ART device is designed to monitor and rapidly elevate declining blood saturation levels within minutes, all without the need for a mechanical ventilator. Looking ahead, Inspira aims to introduce physicians and perfusionists to its innovative technologies and brand proposition, in preparation for the upcoming deployment of its flagship INSPIRA ART device. This initiative reflects the company’s dedication to improving patient outcomes and advancing the standard of care in respiratory support.
Joe Hayon, co-founder and President of Inspira Technologies, stated, “This distribution agreement represents a crucial milestone in our efforts to introduce Inspira’s innovative technologies to the market. With Glo-Med managing the deployment and maintenance of the INSPIRA ART 100 system in the U.S., I believe that we are well-positioned for the future launch of our flagship INSPIRA ART and other products in our pipeline.”
Matus Knoblich, CEO of Glo-Med, stated, “I believe that the coupling of Glo-Med’s distribution network and capabilities with the industry leading service provided by Med-Stat will create a fully vertically integrated business model where customers can receive the highest level of service and support within the industry sector. Both companies will be working with the same mission in mind: growth and expansion of the Inspira Technologies brand coupled with a fully supported user experience. We believe that this will lead to success for all participants.”
The new distribution facility in Florida will be instrumental in supporting the deployment and maintenance of the INSPIRA ART100 system, while also paving the way for the potential commercialization of additional products in the U.S. market. Operated by Glo-Med Networks Inc., this medical distribution and service center will serve as a central hub for Inspira’s logistics operations, as outlined in their distribution agreement, ensuring the timely and efficient delivery of the company’s innovative medical devices. The facility will feature a dedicated customer support team, offering comprehensive assistance to healthcare providers utilizing Inspira’s products.
According to DelveInsight’s “Cardiopulmonary Bypass Equipment Market Report”, the global cardiopulmonary bypass equipment market was valued at USD 405.18 million in 2023, growing at a CAGR of 4.14% during the forecast period from 2024 to 2030, to reach USD 516.82 million by 2030. The demand for cardiopulmonary bypass equipment is motivated by a rise in the prevalence of cardiovascular and respiratory diseases globally which has led to an increased need for surgical interventions. Conditions such as coronary artery disease, heart failure, and congenital heart defects often require complex surgeries, which are facilitated by cardiopulmonary bypass equipment. Secondly, the increasing number of surgical procedures, driven by an aging population and advancements in medical technology, has heightened the demand for cardiopulmonary bypass equipment during the forecast period from 2024 to 2030.
WellSky Acquired Leading Durable/Home Medical Equipment Software Provider Bonafide®, Enhancing Home Care Solutions
On October 25, 2024, WellSky, a leading technology company in health and community care, announced its acquisition of Bonafide, an enterprise software solution tailored for durable medical equipment (DME) and home medical equipment (HME) providers. This strategic addition will enable WellSky to enhance its presence in the DME/HME sector and provide a more comprehensive integrated software platform. The platform will empower providers to operate their businesses in a compliant, efficient, and profitable manner, ultimately improving service delivery within the healthcare ecosystem.
Bonafide offers a comprehensive suite of features, fully integrating purchasing, inventory management, order processing, document management, patient communication, and analytics into a single intuitive user interface. The combination of WellSky and Bonafide will empower more durable medical equipment (DME) and home medical equipment (HME) companies to enhance their operations, streamline ordering and administrative processes, and achieve greater success amid evolving industry challenges and regulatory changes. This strategic integration positions WellSky to better support providers in delivering high-quality care while navigating a complex healthcare landscape.
“With the rise in chronic conditions, a rapidly aging population, and an increased focus on patient-directed care, the need for high-quality home-based healthcare solutions is more critical than ever,” said WellSky chairman and CEO Bill Miller. “I’m thrilled to welcome Bonafide to WellSky. Together we will work to support this expanding market with the full suite of WellSky solutions and our tech-enabled services to better collaborate and achieve successful outcomes for even the most complex patient populations.”
“Since our founding more than 40 years ago, Bonafide has made it our mission to offer the best technology available to the DME/HME industry,” said Mark Ludwig, CEO of Bonafide. “Now, by joining forces with WellSky, we embark on an exciting new chapter for our team, our clients, and our future growth. Together, we will be able to expand our capabilities, accelerate our mission, and deliver even greater value to the clients we serve.”
WellSky’s existing offerings in home infusion and home health are highly complementary to Bonafide’s robust solutions, industry expertise, and market knowledge. Together, WellSky and Bonafide will focus on further investing in services, analytics, and interoperability to enhance care delivery and strengthen financial performance. This partnership aims to equip providers with the tools necessary to meet the increasing demand for home health services, ultimately improving patient outcomes and operational efficiency in the healthcare sector.
According to DelveInsight’s “Durable Medical Equipment Market Report”, the global durable medical equipment market was valued at USD 228.22 billion in 2023, growing at a CAGR of 5.99% during the forecast period from 2024 to 2030 to reach USD 323.65 billion by 2030. The demand for durable medical equipment is primarily being boosted by the rising prevalence of chronic diseases across the globe. The growing number of individuals with disabilities underscores the necessity for medical equipment capable of facilitating mobility within various environments. The major cause of disabilities in people is a disease associated with nerve damage, limb loss, paralysis, etc. The growing geriatric population is also creating the demand for durable medical equipment such as wheelchairs and crutches which results in the expansion of the market. These are some of the key factors that are responsible for contributing to the positive growth of the durable medical equipment market during the forecast period from 2024 to 2030.
