“As a physician and the head of the Israeli ECMO Society, I am delighted to witness this exciting milestone where hospitals will have the opportunity to acquire and use the innovative and technologically cutting-edge INSPIRA™ ART100.” said Dr. Dekel Stavi, head of the Israeli Extra-Corporeal Membrane Oxygenation (“ECMO”) Society and Inspira’s Medical Director. In addition to this Dagi Ben-Noon, CEO of Inspira Technologies, commented, “After we received FDA approval for the INSPIRA ART100 that will allow us to establish our presence in the U.S., receiving AMAR approval will facilitate the creation of business opportunities in new regions and emerging markets.”
As per 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 primarily motivated by the increase in the prevalence of cardiovascular diseases like atrial fibrillation, atrial flutter, and supraventricular tachycardia, decrease in heart muscle elasticity, decrease in heart output, rising burden of the geriatric population, increasing technological advancements and surge in product development activities among others during the forecast period.
Oticon Medical’s Sentio™ System Received Regulatory Clearance in Both US and Europe
On July 15, 2024, Oticon Medical, a global company specializing in implantable hearing solutions, committed to enhancing auditory experiences across all life stages received the U.S. Food and Drug Administration (FDA) clearance and CE mark for its first active transcutaneous bone conduction hearing system, the Sentio™ System. The Sentio System delivered the proven benefits of the Ponto™ System, with additional features, in a transcutaneous design.
The system included the Sentio 1 Mini as an external sound processor and the Sentio Ti Implant placed under the skin. It was noted as the smallest transcutaneous system available at the time. While Ponto and other percutaneous bone-anchored hearing systems used skin-protruding abutments, the Sentio System provided an alternative by keeping the skin intact. It offered an additional solution for patients, supporting their commitment to “freedom of choice.”
“With the launch of Sentio System, we provide best-in-class and the smallest active transcutaneous system. More importantly, Oticon Medical now offers a complete portfolio of bone-anchored hearing systems. This portfolio meets the needs of patients and customers, and fits diverse clinical settings and global reimbursement schemes for the treatment. We strongly believe that offering a broad portfolio is the path to achieving our mission to “Help more people” and give more potential users the quality of life improvements these systems offer.” commented René Govaerts, President & General Manager, Oticon Medical.
As per DelveInsight’s “Bone Anchored Hearing Systems Market Report” the global bone-anchored hearing systems (BAHS) market is estimated to grow at a CAGR of 6.21% during the forecast period from 2024 to 2030. The demand for bone-anchored hearing systems is primarily being boosted by the rising number of cases of hearing loss owing to various factors such as hearing disorders, hereditary disorders, and birth complications. Additionally, the rise in the surge in government and non-government programs for raising awareness regarding hearing disorders and the growing geriatric population are some of the contributing factors to the growth of the bone-anchored hearing systems market during the forecast period from 2024 to 2030.
Vectorious Medical Technologies Announced the Successful Implantation of the V-LAP Left Atrial Pressure Sensor in its First U.S Patient
On July 16, 2024, a patient in Cincinnati became the first in the United States to receive an innovative system that enabled remote monitoring of his heart and congestion status, as well as self-adjustment of diuretics.
Vectorious Medical Technologies Ltd. developed a miniature pressure sensor that was implanted within the heart via standard minimally invasive transvenous catheterization. The sensor measured Left Atrial Pressure (LAP), the earliest and most accurate indicator of fluid overload and congestion status. The system supported a scalable, physician-directed patient self-management approach, allowing heart failure (HF) patients to take an active role in managing their disease. By using the V-LAP system, patients could better understand their disease and adjust diuretics, daily activities, and fluid volume accordingly.
Sitaramesh Emani, MD, Director of Heart Failure Clinical Trials at The Christ Hospital in Cincinnati, Ohio, performed the first V-LAP implantation in the United States. A total of 56 V-LAP implantations were conducted, resulting in over 40,000 days of LAP monitoring. This study, along with the ongoing clinical program in Europe and Israel, has informed an upcoming U.S. pivotal trial.
“The successful first U.S. V-LAP implantation represents a pivotal moment in heart failure management. By integrating real-time left atrial pressure monitoring into patient care, we are on the cusp of a transformative shift towards more proactive, personalized treatment strategies. This innovative approach aims to improve patient outcomes through a reduction in hospitalizations and enhancement of overall quality of life for heart failure patients, but will do so by empowering patients to actively manage their own care. The data collected from the VECTOR-HF IIb trial will be instrumental in moving our field forward” said Dr. Sitaramesh Emani.
The initial studies of the V-LAP system, as recently published in the European Journal of Heart Failure, showed promising results. Throughout 85% of the overall follow-up duration (26.98 patient-years, 9,593 LAP monitoring days), patient self-management alone proved sufficient to maintain HF patients without congestion and within safe LAP ranges. This led to a significant reduction in the rate of HF-related hospitalizations and marked improvements in quality of life, as evidenced by enhancements in the 6-minute walk distance and the Kansas City Cardiomyopathy Questionnaire.
Eyal Orion, MD, co-founder and CEO of Vectorious, said, “We look forward to expanding our clinical activities in the U.S. and work closely with physicians, nurses, FDA, and our partners towards a pivotal trial. Recent data published in JAMA Cardiology suggests recent plateaus or reversals after long-standing declines in cardiovascular mortality, particularly for HF related mortality in the U.S. between 1999 and 2021. I strongly believe that the technology and Treatment paradigm we develop have the potential to reverse this concerning trend, and our team is fully committed to this mission.”
According to DelveInsight’s “Left Atrial Appendage Closure Devices Market Report,” the global left atrial appendage closure device market was valued at USD 1,206.94 Million in 2023, growing at a CAGR of 11.45% during the forecast period from 2024 to 2030 to reach USD 2,564.70 million by 2030. The demand for left atrial appendage closure devices is primarily being bolstered by the rising prevalence of cardiovascular disorders such as atrial fibrillation, ischemic strokes, and heart attacks. Additionally, increasing technological advancement in the domain of left atrial appendage closure, is another key factor that is contributing to the growth of the left atrial appendage closure market during the forecast period from 2024 to 2030.
SpineGuard Filed its “510K” Dossier in the US for the Clearance of its New Smart Drilling Device Designed Specifically for Sacroiliac Joint Fusion
On July 17, 2024, SpineGuard, an innovative company that deployed its DSG® (Dynamic Surgical Guidance) local conductivity sensing technology to secure and streamline the placement of bone implants, announced the filing of its “510K” regulatory dossier in the US with the FDA, seeking clearance to commercialize its new device designed to secure the Posterior sacroiliac Fusion (PsiF) surgical procedure.
SpineGuard intended to continue its sales drive, particularly in the United States, and to roll out three new products embedding DSG® technology that satisfied unmet clinical needs (the PediGuard Threaded adapted to scoliosis correction via anterior approach, the PediGuard Canulated designed for sacroiliac fusion named PsiFGuard, and the DSG Universal Drill Bit compatible with power drills and surgical navigation in the spine), aiming to sustain double-digit growth in the coming quarters. The company also worked on clearing the entire PediGuard range in China and establishing strategic partnerships in the dental implantology and surgical robotic fields.
Troy Schifano, CEO and Co-Founder of Omnia Medical, said “As early pioneers in posterior sacroiliac joint fusion, Omnia has witnessed firsthand how important consistently locating the joint is to the success of the procedure. This seemingly straight-forward step is the key to placing the implant accurately, giving it the correct environment to facilitate fusion. The PsiFGuard will give physicians the immediate feedback needed to properly place the initial PsiF instrumentation and, ultimately, the implant. The security provided by PsiFGuard will allow both physicians and patients to feel confident that PsiF was the right choice for treating their chronic sacroiliac pain. Together with SpineGuard, Omnia looks forward to bringing this long overdue technology to the sacroiliac joint fusion market, as we continue being the innovation leader in posterior sacroiliac joint repair.”
According to DelveInsight’s “Spinal Fusion Devices Market Report”, the global spinal fusion devices market was valued at USD 6.49 billion in 2023, growing at a CAGR of 4.55% during the forecast period from 2024 to 2030 to reach USD 8.47 billion by 2030. The rise in the demand for spinal fusion devices is primarily attributed to the rising prevalence of spinal disorders such as degenerative disc disorders, spondylolisthesis, disc herniation, and spinal stenosis among the growing old-age population worldwide; the increase in demand for minimally invasive surgeries. In addition, technological advancement in the product line, and new product launches among others are also expected to drive the global spinal fusion market.
Bedal International Raised $11 Million to Escalate the Growth of its FlexGRIP® Catheter Securement Devices
On July 12, 2024, Bedal International, a Belgian-based medical device company that delivers next-generation catheter securement solutions, announced the successful closure of an $11 million funding round. The investment was intended to support the company’s ongoing global growth.
The funding round was led by White Fund, a Belgian MedTech venture capital fund, and SFPIM, the sovereign wealth fund of Belgium. Participation also came from U.S.-based MedTech investors, along with Bedal’s primary existing investors, F3Finance and LRM. The management team of Bedal also contributed to the funding round.
“Since we founded Bedal, it has already been an incredible journey from launching the devices to growing into a global footprint.” said Alexander Van Damme, CEO of Bedal International. “This new funding marks the beginning of a next chapter for us, focused on setting a new standard in the market.”
Bedal marketed the FlexGRIP catheter securement devices, which helped patients safely secure their catheters, reducing the risk of complications and improving overall patient outcomes. The FlexGRIP devices were in use in more than 34 countries globally, and Bedal successfully closed global deals with market-leading catheter companies. The additional funding allowed Bedal to expand its operations and commercial efforts, with a strong focus on further growing in the US market.
“White Fund and SFPIM are excited to support Bedal’s mission to improve patient care through its innovative devices,” said Eric Brandt of White Fund, Céline Vaessen, CIO at SFPIM also adds “We believe in Bedal’s potential to become the golden standard for catheter care. We are proud to be part of their promising growth journey and are committed to supporting their product development engine with the ambition of making a profound impact on the lives of patients and caregivers.”
According to DelveInsight’s “Peripherally Inserted Central Catheter (PICC) Devices Market Report”, the global peripherally inserted central catheter (PICC) devices market was valued at USD 976.13 million in 2023, growing at a CAGR of 5.29% during the forecast period from 2024 to 2030 to reach USD 1,326.59 million by 2030. The demand for peripherally inserted central catheter devices is primarily being boosted owing to key factors such as the increasing incidence of cancers, and infectious diseases, among others, technological advancements in product portfolio, and proper reimbursement coupled with increasing product launches, thus creating a positive market growth for the Peripherally Inserted Central Catheter (PICC) Devices market during the forecast period from 2024 to 2030.
Mytonomy Inc. Announced a Supplier Agreement With Vizient, Inc., Marking a Significant Milestone in Their Strategic Partnership
On July 15, 2024, Mytonomy Inc., a leader in cloud solutions for health education and engagement, announced that it had entered into a supplier agreement with Vizient, Inc., the largest provider-driven healthcare performance improvement company in the United States. The products covered under this agreement included the Mytonomy Cloud for Healthcare, a software engagement platform covering over 100 conditions with over 3,000 clinical video episodes spanning the entire patient journey.
“We are pleased to offer our award-winning digital health solution to Vizient’s customers. Mytonomy is an immediate value-add to procedure-oriented service lines requiring patient education in cardiology, orthopedics, OB-GYN, bariatric surgery, gastroenterology, and others. With our focus on driving high usage rates, Mytonomy helps providers substitute video automation of communication for staff time,” said by Vinay Bhargava, Mytonomy President and Co-founder.
Mytonomy was featured in a KLAS Research Emerging Company Spotlight report published in April 2024, receiving an overall score of 90.5*. Mytonomy Cloud for Healthcare’s early data score was above average for vendor solutions in the Patient Education category.
“This contract with Vizient improves hospitals’ access to our solution, which extends the care team outside the hospital’s four walls. Our team’s prior work experience at tech firms like Epic, Google, and Oracle makes us an ideal thought partner for health systems as they help their staff with automation strategies involving AI and content,” said by Bhargava.
According to DelveInsight’s “Digital Health Market Report”, the global digital health market was valued at USD 178.37 billion and is estimated to grow at a CAGR of 18.25% during the forecast period from 2024 to 2030 to reach USD 486.55 billion by 2030. The digital health market is observing remarkable market growth due to the growing awareness, adoption of digital healthcare, and the rising demand for IoT, AI, and others in the healthcare industry. Further, the increasing patient pool suffering from chronic disease and the rising burden of the geriatric population across the globe will increase the need for remote and virtual patient care, leading to the increased demand for digital health. Additionally, the growing demand for remote patient monitoring and mobile health applications, increasing penetration of smartphones in the healthcare industries along with the increasing product or service launches & approvals, and the presence of key players in the market, among others will create a requisite for the digital health in the market. Therefore, the market for digital health is estimated to grow at a substantial CAGR during the forecast period from 2024 to 2030.
