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Rapid Medical Obtains FDA Clearance for the World’s Smallest and Only Adjustable Thrombectomy Device
On July 26, 2022, Rapid Medical, a leading developer of advanced neurovascular devices, received Food and Drug Administration (FDA) 510(k) clearance for TIGERTRIEVER™13 for large vessel occlusions.
The TIGERTRIEVER 13 is the world’s smallest revascularization device, designed to remove thrombus from delicate brain blood vessels during an ischemic stroke. It is the only device that adapts to the vasculature and clot, which is a less traumatic approach than other devices.
The TIGERTRIEVER portfolio’s unique adjustability arises from the complex three-dimensional braiding of the product. TIGERTRIEVER is precisely controlled to capture the thrombus and remove the tension from the vasculature before the removal. Because of its adjustability, TIGERTRIEVER 13 has the lowest profile of any stent retriever which is 24% smaller than 3 mm devices, allowing for easier navigation in difficult anatomies. The ability to customize each procedure can provide new levels of safety for higher-risk thrombectomies.
“Thousands of procedures have already been performed with TIGERTRIEVER 13 worldwide,” describes James Romero, President, Americas, of Rapid Medical. He also added, “Now U.S. physicians finally have access to TIGERTRIEVER 13’s unique capabilities to further benefit patients suffering from ischemic stroke.”
Dr. David Fiorella of Stony Brook University Medical Center in Stony Brook, NY, states, “The neurovascular field has been waiting for a thrombectomy device dedicated to small vessels,” Dr. added, “Medical therapy is currently suboptimal for these patients, so there can be a huge benefit for devices that emergently restore blood flow while minimizing the potential for harm.”
As per DelveInsight’s “Neurovascular Thrombectomy Devices/Neurothrombectomy Devices Market” report, the global Neurovascular Thrombectomy Devices/Neurothrombectomy Devices market was valued at USD 722.78 million in 2021, growing at a CAGR of 6.15% during the forecast period from 2022 to 2027 to reach USD 1,033.33 million by 2027. The neurovascular thrombectomy devices/neurothrombectomy devices market is slated to witness increasing revenue owing to factors such as the rising prevalence of neurovascular disorders such as ischemic stroke and hemorrhagic stroke across the globe which require neurovascular thrombectomy devices for their treatment, rising burden of old population, and increasing product developmental activates are further expected to result in the appreciable revenue growth in the neurovascular thrombectomy devices/neurothrombectomy devices market during the forecast period (2022-2027).
GE Healthcare Launched Next-Gen X-Ray System, Named Definium™ 656 HD
On August 02, 2022, GE Healthcare, a leading global medical technology, and life sciences company, launched its most advanced fixed X-ray system yet, the next-generation Definium 656 HD.
The system delivers consistent, highly automated, efficient exams that impart clinical confidence while simplifying workflow, improving consistency, and reducing errors to help keep radiology departments running smoothly.
The Definium 656 HD, includes the Intelligent Workflow Suite, which is a versatile digital radiographic system that is powered by GE’s FlashPad HD high-resolution detectors and the most recent Helix 2.2 advanced image processing software. The system functions as a personal assistant, assisting technologists in delivering consistent, efficient, and highly automated imaging exams that instill clinical confidence across the radiology department, while also improving the overall patient experience by allowing healthcare providers to maintain workflow control in the room.
The next-generation Definium 656 HD reduces patient positioning time, physical workload, errors, and image retakes with simple features that accelerate the imaging process without sacrificing image quality, such as 5-axis motorization and auto-positioning, automated in-room workflows, AutoRad software, and Intelligent Workflow Suite which is a 3D camera technology to produce more consistent images while avoiding repeated X-rays before they occur.
The Definium 656 HD also features high-quality detectors, advanced applications, and AI-driven image processing to reduce variability and provides optimal image quality.
“At GE Healthcare we strive to provide meaningful technologies and solutions that can help our customers deliver the best possible patient care. With a focus on technologist workflow and efficiency, patient satisfaction, and exam quality, we are elated to introduce the next-generation Definium 656 HD x-ray system,” says Tanya Lancaster, General Manager for Fixed X-ray.
Tanya Lancaster, added, “This new offering enables healthcare providers to benefit from the highest levels of motorization, automation, assistive intelligence, and advanced applications offered to date in GE Healthcare’s fixed X-ray portfolio. Not only does this system provide optimal image quality, but it can also reduce the physical workload for technologists and streamline the overall exam workflow. While addressing some of the key challenges technologists and radiologists face, Definium 656 HD can help improve department efficiency along with staff and patient experience. With our next-generation Definium 656 HD, we are excited to deliver our latest in patient-centric innovation to help our customers make every image count.”
According to DelveInsight’s “X-Ray Devices Market” assessment, the global X-ray devices market will grow at a CAGR of 8.36% during the forecast period from 2022 to 2027. The x-ray devices market is witnessing positive growth owing to the factors such as rising cases of cancer cases, rising prevalence of cardiovascular disorders, orthopedic disorders, & musculoskeletal system diseases, technological advancements in product development, increase in the number of product offerings, thereby contributing to the growth of the X-Ray devices market during the forecast period from 2022 to 2027. As per DelveInsight’s analysis, in the product type category, the digital type of X-Ray equipment is estimated to hold a significant share in the X-Ray devices in the year 2021. This can be ascribed to the advantages associated with digital X-ray systems such as reduced time, reduction in radiation doses, reduction in cost, and others.
Bluejay Diagnostics, Inc. Announced Positive Results of Analytical and Clinical Studies of Bluejay’s Symphony IL-6 Test
On July 27, 2022, Bluejay Diagnostics, Inc., a medical diagnostics company focused on improving patient outcomes using its Symphony System, announced the positive results of analytical and clinical studies of Bluejay’s Symphony IL-6 Test at AACC 2022, the leading industry conference for clinical laboratory medicine.
It was found that the analytical and clinical performance of the Symphony IL-6 Test is comparable to the Emergency Use Authorization (EUA)-approved Roche Elecsys® IL-6 assay.
According to the results, dysregulated interleukin-6 (IL-6) levels underpin several pathological conditions, including sepsis, cancer progression, rheumatoid arthritis, and many other conditions. Also, previous research has shown that high levels of IL-6 are an early indicator of SARS-CoV-2-induced hyper inflammation, disease severity, and multi-ssssorgan failure.
The Symphony System from Bluejay is intended to address the need for simple, reliable, rapid, near-patient testing by providing quantitative measurements of specific biomarkers to determine the need for additional patient care and monitoring. The user-friendly system requires no sample preparation or dedicated personnel and has been shown in published clinical studies to deliver results in less than 20 minutes.
According to the findings of the analytical and clinical studies, the Symphony IL-6 Test is a novel technology for use in the Emergency Department and Intensive Care Unit to identify COVID-19 patients at higher risk for severe disease, including the need for Invasive Mechanical Ventilation (IMV). This conclusion is based on the study results and the Symphony IL-6 NPT’s unique characteristics in comparison to much larger, more expensive lab analyzers. The authors highlight key differentiators such as faster turnaround time (20 minutes), ease of use (tested directly from whole blood, without the need for significant laboratory infrastructure), and analytical precision, as mentioned below.
Key Study Highlights:
- Clinical Performance (NPV): The Symphony IL-6 NPT demonstrated a 98% Negative Predictive Value (NPV). The 98% NPV indicates the usefulness of the test in ruling out the risk of severe disease, including the risk of IMV, in patients with COVID-19.
- Clinical Performance (Sensitivity and Specificity): An evaluation of 147 COVID-19 patient samples, including 18 IMV patients, found the Clinical Sensitivity and Specificity of the Symphony IL-6 Test were slightly better but comparable, based on Sensitivity and Specificity for the Symphony IL-6 NPT of 89% and 64%, respectively, to other devices currently permitted to be used clinically.
- Analytical Performance: Results of an evaluation of 152 COVID-19 patient samples tested with the Symphony IL-6 NPT and the Roche Test showed an excellent correlation between the two test methods (r=0.9490).
According to DelveInsight’s “Rapid Diagnostic Kits Market” assessment, the global rapid diagnostic kits market is expected to grow at a CAGR of 3.55% during the forecast period (2022-2027). The increase in the rapid diagnostic kits market is predominantly owing to the increasing prevalence of diabetes, COVID-19 infection, increasing incidence of human immunodeficiency virus (HIV) infection, and the increased demand for point-of-care immunodiagnostic tests. Additionally, as per DelveInsight analysis, North America is expected to hold a considerable market share in the year 2021. This is due to the rising incidence of HIV infections and increasing regulatory approval of rapid diagnostic kits in the market among others.
Glaukos Received FDA 510(K) Clearance for Istent Infinite System
On August 05, 2022, Glaukos Corporation, an ophthalmic medical technology and pharmaceutical company, announced that it has received 510(k) clearance from the FDA for the iStent infinite Trabecular Micro-Bypass System.
The iStent infinite is indicated for use as a stand-alone procedure to reduce elevated IOP in patients with primary open-angle glaucoma who have failed to respond to prior medical and surgical therapy.
The iStent infinite comes with three heparin-coated titanium stents preloaded into an auto-injection system that allows the glaucoma surgeon to inject stents over 6 hours around Schlemm’s canal. The stents, once in place, are intended to lower IOP by restoring the natural, physiological outflow of aqueous humor. The iStent infinite works in a similar way to the company’s two-stent iStent inject W Trabecular Micro-Bypass System, which is approved by the FDA for the reduction of IOP in adult patients with mild-to-moderate primary open-angle glaucoma who are also having cataract surgery.
“This FDA clearance for iStent infinite represents a significant milestone for Glaukos and the MIGS market as the first FDA-cleared micro-invasive implantable device indicated for use as a standalone treatment option for glaucoma patients not undergoing concomitant cataract surgery,” Thomas Burns, chairman, and chief executive officer said in a company news release.
Thomas Burns added, “Supported by strong pivotal data highlighting favorable safety and effectiveness, we believe iStent infinite provides ophthalmic surgeons a compelling new interventional glaucoma alternative designed to provide foundational, 24/7 IOP control for their patients in need. We are grateful to the clinical investigators and patients who participated in the clinical trial for their instrumental roles in helping us reach this pioneering achievement and bring iStent infinite to the U.S.”
According to DelveInsight’s “Glaucoma Drainage Devices Market” assessment, the global glaucoma drainage devices market is expected to grow at a 11.95% CAGR during the forecast period (2022-2027) to reach USD 1,184.39 million by 2027. The increase in glaucoma drainage devices is predominantly owing to the increasing geriatric population, increasing prevalence of glaucoma, growing prevalence of lifestyle disorders such as hypertension and diabetes, and technological innovation in product development worldwide. Additionally, as per DelveInsight analysis, in the product type segment, minimally invasive glaucoma surgery (MIGS) is expected to hold a considerable market share of 54% in the year 2021. This can be ascribed to the fact that MIGS devices are preferred by end-user. Moreover, the MIGS devices can be used with add-on cataract surgery, thereby offering surgeons an extended alternative for disease treatment. Therefore, the advantages offered by MIGS devices are predicted to aid in the growth of glaucoma drainage devices during the forecast period.
NeuroOne Announced Exclusive Development and Distribution Agreement with Zimmer Bioment for Evo® Seeg Electrode, an Electrode for Extended Intraoperative Use
On August 03, 2022, NeuroOne Medical Technologies Corporation, a medical technology company focused on improving surgical care options and outcomes for patients suffering from neurological disorders announced that the company has entered into an amendment to its exclusive development and distribution agreement with Zimmer Biomet, Inc. that will provide the company with a USD 3.5 million accelerated payment within 10 business days which relates to certain milestone payments. In addition, Zimmer Biomet will receive a Warrant with an exercise price of USD 3.00 per share to purchase 350,000 shares of the Company’s common stock.
Dave Rosa, Chief Executive Officer of NeuroOne, states, “I want to thank Zimmer for all their support to date and their confidence in our business, technology, and future endeavors. This agreement accomplishes multiple objectives for NeuroOne, most importantly by providing additional capital to our balance sheet in the short-term without the need for highly dilutive financing, and further reinforcing our ongoing partnership with Zimmer.”
Brian Hatcher, President of the Trauma, CMFT, Foot and Ankle Division of Zimmer said, “We look forward to continuing the relationship with NeuroOne as we advance our mission to alleviate pain and improve the quality of life for people around the world.”
Zimmer Biomet has exclusive global distribution rights to the Company’s Cortical and sEEG diagnostic electrode technology under an Exclusive Development and Distribution Agreement signed by both parties in July 2020.
According to DelveInsight’s “Intra Operative Imaging Market” assessment, the global Intra Operative Imaging market was valued at USD 2.10 billion in 2021, growing at a CAGR of 5.68% during the forecast period from 2022 to 2027 to reach USD 2.27 billion by 2027. The rise in demand for intraoperative imaging is primarily due to the rising prevalence of various disorders such as spine disorders, neurological disorders, cardiac disorders, and others that require surgery as one of the treatments. In addition, an increase in surgical volume, growing approval, and technological advancement in the product arena, among others, are expected to propel the global intraoperative imaging market during the forecast period.
Kaia Health Announced Rise-Up Randomized Controlled Trial Results Where Kaia Health App Reduces Back Pain by 46%
On August 03, 2022, Kaia Health, the world’s largest digital therapeutics company that creates accessible, evidence-based treatments for a range of conditions, including MSK pain and COPD, announced the results of the Rise-uP zrandomized controlled trial, which demonstrated that using digital multimodal therapy reduces back pain significantly.
After a 12-month trial period, study participants who used the Kaia Health app reported a 46% reduction in pain and significant improvements in functional capacity and mental and physical quality of life metrics.
The study included 1,245 adults with acute, subacute, or recurring non-specific back pain who were assessed four times over the year.
Participants were given access to the Kaia Health app, which employs a multimodal therapy concept and is widely regarded as the gold standard treatment for back pain. Physical exercise, relaxation, breathing techniques, education about the causes of pain, diet and lifestyle changes, and stress management are all part of the program.
On an 11-point numeric rating scale, Kaia Health users’ pain was reduced by 1.85 points after 3 months and 2.55 points after 12 months when compared to participants in the control group who received traditional care. The control group experienced only a 24% reduction in pain. Even after controlling for other factors such as age and pain duration, the difference remained. The intervention group also saw significant improvements in their functional ability, anxiety, depression, stress, and mental and physical quality of life.
“As the world’s most clinically validated digital musculoskeletal solution, we have a steadfast commitment to research,” according to Nigel Ohrenstein, president of Kaia Health. He added, “This study further demonstrates the efficacy in reducing pain for the millions of people who experience back pain and improves the overall quality of life.”According to DelveInsight’s “Telehealth Market” assessment, the global telehealth market is expected to grow at a 31.57% CAGR during the forecast period (2022-2027). The increase in the telehealth market is primarily attributed to the rise in shifting focus among the population for lowering the healthcare cost and the rise in the government initiatives to launch telemedicine to provide increased access among the patient population. Moreover, the sudden outbreak of the COVID-19 pandemic and the increasing number of diagnostic telehealth platforms across the globe will drive the market for telemedicine. Additionally, as per DelveInsight analysis, in the region segment, North America held a considerable market share in the year 2021 and is expected to do the same in the upcoming years. This is due to the rise in shifting focus among the population for lowering the healthcare cost and a rise in the government initiatives to launch telemedicine to provide increased access among the patient population will increase the demand for telehealth in North America.