“This project is a prime example of our mission in action,” said Dylan Crotty, president of Stryker’s Instruments division. “We listened to our customers’ evolving needs and are engaging leading surgeons to create a product that adds confidence to their workflow.”
“Spine Guidance Software with Copilot is just the beginning of our development pipeline,” said Robbie Robinson, president of Stryker’s Spine division. “While focusing on innovation and the integration of our implants, instrumentation and enabling technologies, we strive to help surgeons perform safe and efficient procedures that enable better patient outcomes.”
The Smart Zones feature for bone resection provides auditory and sensory alerts when surgeons approach the designated anatomical boundaries with the high-speed drill. Complementing this, the Copilot Smart Driver automatically stops at the specified depth, enhancing precision during pedicle preparation and screw insertion. This automatic depth stop function is a unique technology that is activated exclusively with Stryker implants.
As per DelveInsight’s “Spinal Surgery Device Market Report,” the global spinal surgery device market is estimated to grow at a CAGR of 5.65% during the forecast period from 2024 to 2030. 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 2024 to 2030.
VIALASE Received CE Mark for the First Femtosecond Laser for Glaucoma Treatment: The VIALASE® Laser
On July 30, 2024, ViaLase, Inc., a clinical-stage medical technology company focused on addressing unmet needs in conventional glaucoma treatment, announced that it received CE (Conformité Européenne) Mark approval in the European Union (EU) for its ViaLase® Laser for treating adult patients with primary open-angle glaucoma (POAG).
The ViaLase Laser combined the precision of a femtosecond laser with the accuracy of micron-level image guidance to deliver a noninvasive glaucoma treatment known as femtosecond laser, image-guided, high-precision trabeculotomy, or FLigHT. This technology addressed a significant unmet need for patients who could benefit from a non-pharmacologic, incision-free procedure without compromising their therapeutic goals.
“The ViaLase Laser represents a monumental transformation in interventional glaucoma care in its potential to deliver surgery-like results without the need for opening the eye and thus, reducing complications associated with more invasive, surgical procedures,” said Tibor Juhasz, PhD, Founder and Chief Executive Officer, ViaLase, Inc. “Early clinical data indicate that FLigHT is safe and effective at lowering intraocular pressure (IOP). We look forward to working with our distribution partners to bring this groundbreaking technology to physicians and patients in Europe.”
“We have good evidence that early, non-medical intervention offers better long-term disease control and preservation of vision – which is what matters most to patients. I’m delighted that physicians and patients can soon benefit from the ViaLase Laser, which brings a new level of imaging and precision to glaucoma care. Furthermore, the patient’s lens status has no bearing on their ability to undergo FLigHT, expanding access to patients who previously had limited treatment options,” said Richard Lewis, MD, Chief Medical Officer, ViaLase, Inc.
ViaLase had formed formal distributor partnerships with Global Surgical Service for Spain and Portugal, and Teleon Surgical for Germany and Austria. Both organizations possessed extensive experience in ophthalmology and a well-established commercial presence in their respective regions. These strategic alliances were set to ensure prompt and efficient distribution of the ViaLase Laser to physicians and patients.
As per DelveInsight’s “Micro Invasive Glaucoma Surgery (MIGS) Devices Market Report,” the global Micro Invasive Glaucoma Surgery (MIGS) Device market was valued at USD 406.55 million in 2023, growing at a CAGR of 13.34% during the forecast period from 2024 to 2030 to reach USD 972.26 million by 2030. The demand for micro-invasive glaucoma surgery devices is primarily being boosted by the growing prevalence of glaucoma. Furthermore, the increasing lifestyle disorders such as diabetes and hypertension double the chances of causing glaucoma leading to vision loss and blindness, thereby boosting the market of microinvasive glaucoma surgery devices. Additionally, increasing technical innovation in product development such as less invasiveness and more effectiveness are some of the other key drivers that are responsible for contributing to the positive growth of the micro-invasive glaucoma surgery device market during the forecast period from 2024 to 2030.
The Texas Heart Institute Implanted the BiVACOR® Total Artificial Heart, a First-in-Human Novel Valveless Artificial Heart, Into a Patient With End-Stage Heart Failure as a Bridge to Heart Transplant
On July 25, 2024, The Texas Heart Institute (THI) and BiVACOR®, a clinical-stage medical device company, reported the successful first-in-human implantation of the BiVACOR Total Artificial Heart (TAH) as part of the FDA Early Feasibility Study (EFS). The BiVACOR TAH was a titanium-built biventricular rotary blood pump featuring a single moving part and a magnetically levitated rotor designed to pump blood and replace the failing ventricles of a heart.
The first-in-human clinical study was designed to assess the safety and effectiveness of the BiVACOR TAH as a bridge-to-transplant solution for patients with severe biventricular or univentricular heart failure, particularly when left ventricular assist device support is not advisable. The study planned to enroll four additional patients after the initial implantation at Baylor St. Luke’s Medical Center in the Texas Medical Center.
“The Texas Heart Institute is enthused about the groundbreaking first implantation of BiVACOR’s TAH. With heart failure remaining a leading cause of mortality globally, the BiVACOR TAH offers a beacon of hope for countless patients awaiting a heart transplant,” said Dr. Joseph Rogers, President and Chief Executive Officer of The Texas Heart Institute and National Principal Investigator on the research. “We are proud to be at the forefront of this medical breakthrough, working alongside the dedicated teams at BiVACOR, Baylor College of Medicine, and Baylor St. Luke’s Medical Center to transform the future of heart failure therapy for this vulnerable population.”
Daniel Timms, PhD, Founder and Chief Technology Officer of BiVACOR said, “I’m incredibly proud to witness the successful first-in-human implant of our TAH. This achievement would not have been possible without the courage of our first patient and their family, the dedication of our team, and our expert collaborators at The Texas Heart Institute. Utilizing advanced MAGLEV technology, our TAH brings us one step closer to providing a desperately needed option for people with end-stage heart failure who require support while waiting for a heart transplant. I look forward to continuing the next phase of our clinical trial.”
The successful implantation of BiVACOR’s TAH underscores the promise of innovative technologies in tackling significant challenges in cardiac care, including long transplantation waitlists. Both BiVACOR and The Texas Heart Institute continue to be dedicated to advancing cardiac medicine and enhancing patient outcomes on a global scale.
The BiVACOR TAH represents a major advancement in artificial heart technology. Its compact size fits most adults (Body Surface Area >1.4 m²) and provides sufficient cardiac output for exercise. Utilizing magnetic levitation, the BiVACOR TAH features a unique design with a single moving part: a magnetically suspended dual-sided rotor. This rotor, positioned in separate pump chambers, functions as a double-sided centrifugal impeller to propel blood to both pulmonary and systemic circulations. The TAH eliminates valves and flexing chambers, using MAGLEV technology to achieve pulsatile flow and reduce mechanical wear, blood trauma, and enhance durability and biocompatibility.
According to DelveInsight’s “Total Artificial Heart Market Report”, the global artificial heart market size is estimated at USD 2.60 billion in 2023 and is expected to reach USD 5.30 billion by 2030, growing at a CAGR of 15.40% during the forecast period from 2024 to 2030. The total artificial heart (TAH) market is driven by several key factors, including the increasing prevalence of end-stage heart failure and the rising demand for advanced heart replacement solutions. Advances in technology and engineering have led to the development of more reliable and efficient TAH systems, enhancing their appeal among patients and healthcare providers. Additionally, growing investments in research and development, alongside the expansion of healthcare infrastructure in emerging markets, are fueling market growth. The need for effective long-term solutions for patients who are not suitable candidates for heart transplants also contributes to the market’s expansion. Furthermore, increased awareness and acceptance of TAH as a viable option for end-stage heart failure patients are driving its adoption and market growth.
Diamyd Medical Reported Positive Results From the Interim Analysis of Their Phase 3 Trial in Type 1 Diabetes
On July 30, 2024, Diamyd Medical announced that it completed a successful interim analysis (non-futility test) for its ongoing precision medicine Phase 3 DIAGNODE-3 trial. The interim analysis, reviewed by an independent Data Safety Monitoring Board (DSMB), resulted in a favorable recommendation to continue the trial without any modifications.
“We are extremely pleased with the DSMB’s recommendation to continue the DIAGNODE-3 trial as planned,” said Ulf Hannelius, CEO of Diamyd Medical. “This positive outcome reaffirms our confidence in the potential for Diamyd® to address an unmet medical need in Type 1 Diabetes. We are committed to advancing this promising therapy as part of a process recently approved by the U.S. Food and Drug Administration, allowing for an accelerated approval pathway for Diamyd®. We look forward to achieving our next milestones towards this goal.”
The interim analysis evaluated six-month data from 74 patients enrolled in the trial, assessing the likelihood of achieving one of its co-primary endpoints, specifically the preservation of endogenous insulin-producing capacity measured as stimulated C-peptide. The DSMB’s recommendation was based on the data observed up to that point, indicating that the trial had been on track and had the potential to meet its objectives.
The confirmatory Phase III trial DIAGNODE-3, which evaluated the safety and efficacy of the antigen-specific immunotherapy Diamyd® for Type 1 Diabetes, has been ongoing in the United States and eight European countries. It aimed to enroll up to 330 individuals aged 12 to 29 years who were recently diagnosed with Type 1 Diabetes and carried the HLA DR3-DQ2 haplotype. The trial included further stratification for HLA haplotypes to identify potential superresponders. This patient population was based on previous Phase IIa and IIb trials and a meta-analysis involving over 600 individuals. The trial design was intended to achieve its co-primary endpoints of preserving endogenous insulin production and improving blood glucose control. Diamyd Medical had been exploring the potential for an earlier readout, with the FDA considering C-peptide as a surrogate endpoint for Accelerated Approval based on significant treatment-related benefits. The trial was supported in part by funding from Breakthrough T1D.
According to DelveInsight’s “Blood Glucose Monitoring Systems Market Report”, the global blood glucose monitoring systems market was valued at USD 13.06 billion in 2023, growing at a CAGR of 7.72% during the forecast period from 2024 to 2030, to reach USD 20.40 billion by 2030. The escalating demand for blood glucose monitoring systems is predominantly attributed to the increasing prevalence of diabetes among the population across the globe and the growing burden of the geriatric population who are susceptible to developing hyperglycemia. In addition, the spike in technologically advanced blood glucose monitoring devices product launch and government initiatives to raise awareness regarding proper diabetes management, among others are the factors likely to spur the global blood glucose monitoring systems market.
Cardio Diagnostics Holdings Inc. Launched CDIO.AI, a Redesigned Website That Enhanced User Experience and Highlighted Their AI-driven Cardiovascular Solutions
On July 29, 2024, Cardio Diagnostics Holdings, Inc., recognized as a leader in AI-powered precision cardiovascular medicine, announced that it launched its redesigned website at CDIO.AI. The updated site highlighted the Company’s AI-first strategy and its innovative solutions for preventing, detecting, and managing cardiovascular disease, which is the leading cause of death worldwide. Additionally, the site had simplified access to essential information and resources for investors, partners, patients, providers, and other key stakeholders.
Tim Dogan, Ph.D., Chief Technology Officer and a member of the founding team, commented on the launch: “The new CDIO.AI website is a testament to our commitment to innovation and user-centric design. As the architect of our AI solutions, I am proud to see our vision come to life in a way that makes our advanced technologies more accessible and understandable to all stakeholders. This new site not only highlights our technological capabilities but also underscores our dedication to improving cardiovascular health through precision medicine.”
Meesha Dogan, Ph.D., CEO and Co-Founder of Cardio Diagnostics, expressed her enthusiasm for the new website, “Our new website at CDIO.AI is a clear statement of our identity as an AI-first precision medicine company, dedicated to harnessing the power of artificial intelligence to transform cardiovascular health outcomes. We’ve reimagined our digital presence to not only showcase our AI-driven solutions but also to provide a seamless experience for everyone interacting with our brand.”
The redesigned website provided a significantly improved user experience, allowing each stakeholder group to easily navigate and find relevant information. Investors had streamlined access to financial reports, stock information, and corporate governance details. Patients found clear information about Cardio Diagnostics’ tests and how to obtain them, while healthcare providers benefited from simplified resources for ordering tests and interpreting results. The site also included content for payers and employers on the value of Cardio Diagnostics’ solutions for population health management and offered information for researchers and pharmaceutical companies on collaboration opportunities.
Cardio Diagnostics’ redesigned website, CDIO.AI, highlighted three core solutions showcasing the Company’s AI-driven approach to cardiovascular care. The Epi+Gen CHD test, an AI-driven tool, assessed the three-year risk of coronary heart disease events, including heart attacks, by analyzing genetic and epigenetic biomarkers. The PrecisionCHD test combined epigenetics, genetics, and AI to detect and manage coronary heart disease, offering a more sensitive and accessible diagnostic method than traditional approaches. The Actionable Clinical Intelligence (ACI) platform integrated test results with patient biomarkers and clinical data, providing actionable insights for personalized heart disease management and prevention, which aimed to improve patient outcomes and reduce healthcare costs.
According to DelveInsight’s “Cardiovascular Imaging Equipment Market Report”, the cardiovascular imaging equipment market is estimated to grow at a CAGR of 6.71% during the forecast period from 2024 to 2030. The incidence of cardiovascular diseases (CVDs) is rising due to lifestyle changes, smoking, lack of physical activities, excessive alcohol consumption, obesity, and other factors that are escalating the global market of cardiovascular imaging equipment. Additionally, public health campaigns and initiatives aimed at raising awareness about cardiovascular health encourage individuals to undergo regular check-ups and screenings. Increased public knowledge about the importance of early detection and management of heart diseases leads to higher utilization of cardiovascular imaging services. Furthermore, key market players continuously investing in research and development to introduce innovative cardiovascular imaging technologies, increased partnerships and collaborations, product launches, and approvals ensure that the market remains dynamic and innovative, during the forecast period from 2024 to 2030.
GE Healthcare and AWS Announced a Strategic Collaboration to Accelerate Healthcare Transformation Using Generative AI
On July 25, 2024, GE HealthCare and Amazon Web Services, Inc. announced a strategic collaboration to develop foundation models and generative AI applications aimed at improving medical diagnostics and patient care. GE HealthCare chose AWS as its strategic cloud provider and planned to use its healthcare and generative AI services to create new foundation models. These AI-powered workflows were intended to accelerate healthcare innovations, enhance diagnostic accuracy, improve outcomes, reduce access barriers, and promote equitable care, ultimately easing provider workload and driving industry innovation.
“GE HealthCare has been pioneering medical technology for more than a century. With more than one billion patients around the world touched by our products, we play an important part in improving the quality of care and have a responsibility to continue pushing the boundaries of what’s possible to enable precision care,” said Peter Arduini, President and CEO, GE HealthCare. “This new collaboration with AWS allows us to build on our legacy of innovation by embracing the power of AI to expedite the creation of medical technologies that we expect will redefine clinical workflows and the delivery of care.”
GE HealthCare had intended to use Amazon Bedrock, a fully managed service offering secure access to leading foundation models, to create and deploy custom generative AI applications. By leveraging Bedrock’s enterprise-grade security and privacy along with its extensive selection of models, GE HealthCare planned to develop and scale its own proprietary generative AI applications for healthcare. This aimed to improve efficiency, care delivery, and the patient experience.
“With AWS, GE HealthCare plans to use the cloud to deliver more personalized, intelligent, and efficient care,” said Matt Garman, CEO of AWS. “GE HealthCare is putting generative AI at the heart of their innovation, accelerated by the investments we have made in healthcare-specific cloud services and generative AI capabilities that provide best-in-class security, data privacy, and access to the latest state-of-the-art foundation models. With AWS as their strategic cloud provider, GE HealthCare can build transformative clinical foundation models and applications for the healthcare industry.”
“By combining generative AI with our deep expertise, we’re igniting a new era in healthcare,” said. Dr. Taha Kass-Hout, Global Chief Science and Technology Officer at GE Healthcare. “Our work with AWS is a big step towards helping clinicians make medical care simpler, more efficient, and deeply personalized. It’s about advancing the way we care for people everywhere, one innovative solution at a time.”
“We are optimistic about the ways in which generative AI will be able to transform healthcare for the better, and we look forward to seeing the new tools and applications that result from collaborations across industry and healthcare,” said Dr. Keith Dreyer, Chief Data Science Officer, Mass General Brigham and leader of the Mass General Brigham AI business. “As healthcare systems like Mass General Brigham lean into AI to accelerate their work, we see great potential for new foundation models that utilize advanced technologies.”
GE HealthCare’s internal developers had planned to use Amazon Q Developer, a generative AI-powered assistant, to accelerate software development through real-time code suggestions and task completion. The company also aimed to use Amazon Q Business to explore multi-modal clinical and operational data, reducing cognitive burden on physicians, enabling personalized care, and increasing efficiency. By leveraging AWS’s generative AI technology, GE HealthCare is expected to shorten clinical application development cycles from years to months and speed up the delivery of new healthcare solutions.
Furthermore, GE HealthCare had planned to modernize its applications using foundation models developed on Amazon SageMaker. By creating models specialized for medical use, GE HealthCare aimed to accelerate the development and deployment of web-based medical imaging applications. These models were intended to enhance efficiency, interoperability, and user experience across the company’s solutions. Customers could use GE HealthCare’s generative AI-powered applications, integrated with AWS HealthLake and AWS HealthImaging, to quickly and securely analyze patient data, improving clinical efficiency and patient care.
According to DelveInsight’s “Artificial Intelligence (AI) In Drug Discovery Market Report”, Artificial Intelligence (AI) in drug discovery market is estimated to advance at a CAGR of 37.67% during the forecast period from 2024 to 2030. AI in the drug discovery market is witnessing positive growth owing to factors such as the rising prevalence of various diseases across the globe, advantages of AI in the pharmaceutical sector, and investments in drug research and development, among others. In addition, extensive partnerships and collaborations between public and private entities at the both national and international levels are further expected to boost the AI in drug discovery market during the forecast period from 2024 to 2030.
