Solis Mammography’s Acquisition of MUSIC Imaging Center; Nikon’s SI-PH Phase Condenser Accessory Option; Teijin Launch Surgical Patch; Terumo Cardiovascular’s FDA 510(K) Clearance; Spineart’s 510(k) Clearance; Ceretrieve’s Success in FIH Ischemic Stroke Cases

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Solis Mammography’s Acquisition of MUSIC Imaging Center; Nikon’s SI-PH Phase Condenser Accessory Option; Teijin Launch Surgical Patch; Terumo Cardiovascular’s FDA 510(K) Clearance; Spineart’s 510(k) Clearance; Ceretrieve’s Success in FIH Ischemic Stroke Cases

May 30, 2024

Solis Mammography Announced Acquisition of MUSIC Imaging Center in Gainesville, Florida 

On May 28, 2024, Solis Mammography announced the acquisition of the MUSIC Mammography and Ultrasound Imaging Center in Gainesville, Florida. For more than 10 years, MUSIC has provided patients with an advanced standard of care through an expert radiology team of breast and general ultrasound imagers and technologists.

MUSIC’s established reputation for offering specialized proficiency within a compassionate setting aligns seamlessly with the forward-thinking ethos of the Solis Mammography family of innovative wellness and diagnostic imaging centers. Recognized as a trailblazer in breast imaging and a catalyst for advancements in women’s health, Solis Mammography has upheld a tradition spanning four decades, emphasizing clinical excellence and technological innovation within a patient-centric framework.

The acquisition represents a shared vision of empowering patients to choose a better experience through a caring, compassionate, and patient-centered standard of care.

“Gainesville is a dynamic and rapidly growing market,” said Grant Davies, President and Chief Executive Officer of Solis Mammography. “As we build on MUSIC’s strong foundation, we want to enhance patient access to leading-edge health and wellness services, particularly in the area of breast imaging. By marrying technical innovation and superb clinical leadership with a high-touch, patient-centric experience, we’re able to advance our mission of early detection and impact more lives.”

As per DelveInsight’s Mammography Devices Market Report,” the global mammography devices market was valued at USD 1.78 billion in 2020, growing at a CAGR of 9.15% during the forecast period from 2024 to 2030, to reach USD 3.65 billion by 2030. The demand for mammography devices is primarily witnessing growth on account of the increasing prevalence of breast cancer, technological advancements in breast imaging, and increasing focus on creating awareness regarding routine breast cancer screening programs.

Nikon Introduced the SI-PH Phase Condenser Accessory Option for the ECLIPSE Si Biological Microscope

On May 28, 2024, Nikon Instruments Inc. (Nikon) developed the SI-PH Phase Condenser, for dedicated use with the ECLIPSE Si biological microscope, improving the efficiency of the ECLIPSE SI. The ECLIPSE Si offers various functions that will improve comfort, even during long periods of use. 

Up until now, the ECLIPSE Si required multiple sliders for the transition from brightfield observation to phase contrast observation and magnification switching. With the new SI-PH Phase Condenser, the function of two separate sliders has been combined in one turret, enabling the transition from brightfield observation to phase contrast observation and switching of objectives from low to high magnification without having to replace or remove sliders.

Nikon is proceeding with product development, utilizing high optical technology, based on input from researchers. This will improve on-site workflow from operators and contribute to highly accurate inspections.

The SI-PH Phase Condenser offers efficient observation processes in research fields by facilitating smooth magnification switching and intuitive operation. It enables a seamless transition from low to high magnification observation within one turret, allowing users to switch between different magnification settings effortlessly. Moreover, the condenser allows for easy switching between brightfield and phase contrast observation without the need for replacing or removing sliders, significantly improving work efficiency in research and examination settings. Particularly beneficial in scenarios requiring the observation of large sample volumes, such as research and educational fields, this innovation is expected to drive substantial business improvements.

Conventional biological microscopes often require special tools for adjusting components necessary for phase contrast observation. However, the SI-PH Phase Condenser eliminates this need by enabling easy centering of the ring aperture critical for phase contrast observation through its built-in adjustment mechanism. The updated ECLIPSE Si microscope harnesses the unique features of the SI-PH Phase Condenser, such as smooth magnification switching and effortless ring aperture adjustment, to streamline operating procedures and enhance observation accuracy. This enhancement not only simplifies workflows for laboratory technicians but also ensures the speed and quality of microscopy procedures, ultimately benefiting individuals. Furthermore, the provision of an Online Guide on the website, featuring instructional videos and images summarizing operating procedures, further enhances user accessibility and aids in maximizing the potential of the microscope system.

“The new SI-PH Phase Condenser was developed and designed to help with reducing the workload incurred in microscopic observations performed mainly by laboratory technicians, and people in research and educational settings, so that samples can be observed quickly,” said Tatsuya Yamaguchi, Nikon Executive Officer, General Manager of Healthcare Business Unit. “Thus, we expect that utilizing this product will lead to improvements in the accuracy and speed of microscopic observations during observations of biological cells and examinations. Moreover, this product can be applied to a wide range of tests, such as plaque tests in dentistry, fungus tests in dermatology, blood tests, and chromosome tests. We believe that utilizing this product in educational institutions such as universities, and inspection at laboratories, we can improve the learning skills for all users and contribute to the development of the next generation of professionals.”

“We intend to continue providing solutions that are useful in research and educational settings, while continuing to listen to the voices of our users and reflecting them in our product development,” said Yamaguchi. “We will contribute to improving the quality of life in society through innovation while constantly maintaining our attentiveness and an attitude of pursuing a corporate culture that satisfies our users.”

According to DelveInsight’s Surgical Microscopes Market Report, the global surgical microscopes market was valued at USD 1.12 billion in 2023, growing at a CAGR of 9.70% during the forecast period from 2024 to 2030 to reach USD 1.95 billion by 2030. The Surgical Microscopes market is witnessing positive growth owing to the growing burden of the geriatric population who are susceptible to developing various disorders and, the rising prevalence of various chronic diseases leading to an increase in surgical procedures such as dental, vascular, and others across the globe. In addition, an accumulative focus on developing technologically advanced devices in the product arena is one of the factors contributing to the Global Surgical Microscopes Market.

Teijin Announces Launch of Cardiovascular Surgical Patch in Japan 

On May 28, 2024, Japan’s Teijin, along with its consortium partners Fukui Tateami and Osaka Medical and Pharmaceutical University, plans to launch Synfolium, a new cardiovascular surgical patch, in Japan. Designed for the treatment of congenital heart disease (CHD), the patch is set to be manufactured and distributed by Teijin Medical Technologies starting on 12 June 2024.

The Synfolium surgical patch integrates bio-absorbable and non-absorbable yarns, coated with cross-linked gelatin. Its design enables the patient’s tissue to integrate with the patch, potentially reducing the risk of adverse reactions and enhancing the longevity of the implant.

Teijin developed the technology for coating knitted fabric with gelatin, which effectively prevents blood leakage. Over time, it can be replaced by the patient’s own tissue. 

The company has been progressing with the design, development, and clinical testing of the patch, while also establishing a commercial production system and applying for manufacturing and marketing clearance in Japan.

The collaborative development of Synfolium began in 2014 and has been supported by the Ministry of Economy, Trade and Industry, along with the Japan Agency for Medical Research and Development (AMED).

In April 2018, the product was granted “Sakigake” designation by Japan’s Ministry of Health, Labor, and Welfare, expediting its clinical approval process.

According to DelveInsight’s Vascular Patches Market Report”, the Global vascular patches market is estimated to grow at a CAGR of 7.37% during the forecast period from 2024 to 2030. The increase in demand for vascular patches is primarily attributed to the increase in the prevalence of cardiovascular diseases due to genetic factor, age, obesity, and unhealthy and sedentary lifestyles, bad eating habits and increasing number of geriatric patients prone to vascular diseases, increasing use of vascular patches in surgeries, increased demand of minimally invasive surgeries (MIS), and technological advancements like vascular cell regeneration, cellular integration, and tissue remodeling across the world are anticipated to bolster the market, thereby contributing to the growth of the vascular patches market during the forecast period from 2024-2030.

Terumo Cardiovascular Announced 510(K) Clearance for the CDI OneView™ Monitoring System 

On May 28, 2024, Terumo Cardiovascular announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the CDI OneView Monitoring System. The next-generation CDI Systems platform provides visibility of key patient parameters during cardiopulmonary bypass surgery, critical to perfusion safety and improving patient outcomes.

The new CDI OneView System measures or displays up to 22 key parameters, the newest of which are measured flow (Q), cardiac index (CI), regional cerebral oxygen saturation (rSO2), oxygen extraction ratio (O2ER), Area Under the DO2 Curve (AUC), and measured arterial oxygen saturation (SaO2).  

This innovative system offers maximum configurability and flexibility in how the parameters can be viewed and prioritized to best suit clinical needs and preferences while continuing to provide the critical information on which clinicians have come to rely.

“The world’s leading cardiac centers have trusted CDI Systems for over 30 years. With the launch of the new CDI OneView System, Terumo Cardiovascular continues to bring value and enhanced patient care to healthcare providers and critically ill cardiac patients,” said Robert DeRyke, President and CEO of Terumo Cardiovascular.  “The CDI OneView System technology is the latest extension of Terumo’s commitment to delivering data-focused solutions to the perfusion community.”  

New features and functions of Terumo’s latest patient parameter monitoring system were influenced by extensive perfusionist input from leading global cardiovascular institutions. In response to the growing needs of healthcare providers, the new CDI OneView System now provides real-time O2ER, CI, VO2, and DO2 information to help perfusionists maintain a safe threshold for those parameters. Independently published and reviewed clinical research indicates that maintaining optimal levels during cardiopulmonary bypass can help reduce the incidence of acute kidney injury.

According to DelveInsight’s Cardiovascular Ultrasound System Market Report, the global cardiovascular ultrasound system market was valued at USD 1.61 billion in 2023, growing at a CAGR of 4.79% during the forecast period from 2024 to 2030 to reach USD 2.11 billion by 2030. The cardiovascular ultrasound system market is witnessing positive growth owing to various factors such as the rise in the geriatric population, the increasing incidence of cardiovascular diseases, the increase in sedentary lifestyles, and the rising regulatory approvals for the cardiovascular ultrasound system. Therefore, the market for cardiovascular ultrasound systems is expected to grow during the forecast period from 2024 to 2030.

Spineart Received 510(k) Clearance for SCARLET® AC-Ti Anterior Cervical Cage

On May 28, 2024, Spineart announced 510(k) clearance from the United States Food and Drug Administration (FDA). United for its secure SCARLET® AC-Ti anterior cervical cage.

The SCARLET® AC-Ti builds on a decade of experience with the SCARLET® system. The addition of SCARLET® AC-Ti introduces new features such as the MIMETIX® morphometric profile, developed with digital models of the vertebrae to optimize the contact surface between the implant and the end plates. The system allows for fixing with screws and anchors.

The SCARLET® AC-Ti cervical cage uses Spineart’s exclusive Ti-LIFE technology. Ti-LIFE technology, a proprietary additive manufacturing process, has a porous structure that closely mimics trabecular bone structure.

“This approval underlines our commitment to innovation, continuously evolving our best-in-class products, such as the SCARLET® system,” said Alessia Erlingher, Commercial Director of Spineart.

According to DelveInsight’s Interbody Cages Market Report, the global interbody cages market is estimated to grow at a CAGR of 4.72% during the forecast period from 2024 to 2030. The demand for interbody cages is primarily being boosted by the increasing number of spinal disorders such as degenerative disc degeneration (DDD), spinal fusion, spinal injuries, and others. Further, the rising adoption of advanced and innovative technologies, the increasing demand for minimally invasive surgeries, the rising cases of accidents, and the increasing product launches & approval among others are thereby contributing to the overall growth of the interbody cages market during the forecast period from 2024-2030.

Ceretrieve Announced Groundbreaking Success in FIH Ischemic Stroke Cases

On May 28, 2024, Ceretrieve announced the successful results of the company’s multicenter, single-arm study, showcasing the capabilities of its state-of-the-art aspiration catheter. The study, conducted across two centers, included 20 patients who suffered from acute ischemic stroke (AIS) due to intracranial large vessel occlusion (LVO) and were eligible for thrombectomy within 24 hours of symptom onset. The study was aimed at assessing the safety and initial performance of the Ceretrieve Device.

Ceretrieve is dedicated to revolutionizing stroke care, with a focus on saving lives, reducing disability, and enhancing post-stroke quality of life. Central to this mission is Ceretrieve’s cutting-edge aspiration catheter, which surpasses existing devices in its ability to remove clots with unparalleled efficacy, restoring blood flow in a single pass. Engineered to seamlessly integrate into a standard 6Fr delivery catheter, Ceretrieve’s device provides outstanding trackability and maneuverability, facilitating precise access to the clot site.

As shown in the study conducted, Ceretrieve’s aspiration catheter not only excelled in performance but also ensured the highest safety standards by reducing the risk of releasing clot fragments further into the brain. In the first-in-human (FIH) study 80% Complete/Near-Complete Perfusion was achieved.

The study included two generations of the device, and the results with the improved Gen 2 device are highly impressive: 100% Complete/Near-Complete Perfusion achieved in all treated patients; and 83% First Pass Complete Perfusion (FPE mTICI 3), far exceeding the 30%-40% rate of current gold-standard devices.

Ceretrieve’s CEO, Maysa Mustafa: “The promising results of our clinical studies are the culmination of years of hard work and R&D. Our mission to redefine stroke treatment drives everything we do, and these results signify a major leap forward in saving and dramatically improving lives following an ischemic stroke.”

“The ‘first pass effect’ has been shown to improve patient outcomes” says Dr. Shady Jashan (Galilee Medical Center, Israel) who performed the first neuro thrombectomy procedure with the Ceretrieve device. “Our experience in FIH trials demonstrated that the Ceretrieve device quickly enables complete clot ingestion in first pass even for the most challenging clots and anatomies. This has the potential to dramatically improve patient clinical outcomes.”

Prof. Serder Geyik, MD (Florya Medical Park, Turkey): “The term ‘Everything comes with a price’ is not valid for the Ceretrieve device. Ceretrieve’s device aspirates the clot with a giant bore tip- double than the largest catheters in the market, for maximal vacuum effect without paying the price in trackability. In addition, it provides local flow restriction in the middle cerebral artery reducing distal emboli. It is the only device that includes all the features for successful thrombectomy and first pass effect in one single device. “

Amir Belson, M.D., Ceretrieve Chair: “With Ceretrieve’s advanced technology, we are seeing significant improvements in patient recovery rates. This innovation is setting a new standard in stroke care, offering patients better outcomes and real hope for recovery.”

According to DelveInsight’s Cardiac Arrhythmia Monitoring Devices Market Report”, the global cardiac arrhythmia monitoring devices market will grow at a CAGR of 6.33% during the forecast period from 2024 to 2030. The increase in demand for Cardiac Arrhythmia Monitoring Devices is primarily attributed to the rising prevalence of cardiovascular diseases, rising expenditure on cardiac health globally, rising adoption of mobile and telemetry cardiac monitors, rising prevalence of cardiac arrhythmias, rising technological advancements in monitoring devices, among others are also expected to bolster the demand for these services during the forecast period (2024-2030).

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