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Oct 24, 2024
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On October 21, 2024, iRhythm Technologies, Inc., a leading digital healthcare company specializing in solutions to detect, predict, and prevent disease, announced that the U.S. Food and Drug Administration (FDA) granted clearance for its 510(k) submission addressing previous design changes made to the Zio AT device through a letter to file. The Zio AT device remained available on the market and continued to be shipped to customers across the United States.
“This clearance is related to modifications and certain enhancements to our Zio AT device previously made via letter to file and has been a priority for our teams to demonstrate iRhythm’s commitment to quality, compliance and performance,” said Quentin Blackford, iRhythm President and Chief Executive Officer. “We are pleased to have received this first 510(k) clearance in line with the sequence of how we submitted the first of two 510(k) at the beginning of this year, and we look forward to hearing about our second 510(k) in the near future. Both 510(k) submissions are related to our ongoing remediation efforts with the FDA, and we remain committed to patient safety, physician trust in Zio AT’s clinical performance, service quality, and regulatory compliance.”
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The Zio AT device is a prescription-only outpatient cardiac telemetry device, also known as a mobile cardiac telemetry (MCT) device, used to deliver iRhythm’s MCT services. The system includes several components: the Zio AT patch, an ECG monitor that continuously records heart data for up to 14 days; a wireless gateway, which enables communication between the patch and the Zio ECG Utilization Software (ZEUS) to transmit data during the monitoring period; and ZEUS, iRhythm’s AI-powered algorithm that analyzes the cardiac events sent by the patch and gateway. The Zio AT service provides real-time event transmission reports during the monitoring phase, along with a detailed end-of-wear report containing preliminary findings for the treating physician to review and make final clinical decisions. These diagnostic services are delivered through iRhythm’s independent testing facilities located in San Francisco, California; Deerfield, Illinois; and Houston, Texas.
As per DelveInsight’s “ECG Telemetry Devices Market Report”, the global ECG telemetry devices market is estimated to grow at a CAGR of 7.29% during the forecast period from 2024 to 2030. The demand for ECG telemetry devices is primarily being boosted by the rising prevalence of coronary heart disease across the globe. Further, the rising cases of patients with chronic diseases, the increasing patient admission in intensive care, increasing awareness about self-assessment of heart rhythm, increasing demand for telemedicine, and innovation in product development among others are thereby contributing to the overall growth of the ECG telemetry devices market during the forecast period from 2024 to 2030.
On October 21, 2024, Epitel, a leader in AI-driven brain health technologies, announced that it received U.S. Food and Drug Administration (FDA) 510(k) clearance for REMI Vigilenz™ AI for Bedside Notifications. The REMI Vigilenz AI system performedan automated analysis of EEG data collected by the REMI™ wireless wearable EEG System in near real-time. Notifications were generated when the algorithm detected seizure characteristics in a segment of EEG data. These alerts provided information about potential electrographic seizures, including details on seizure burden and the associated confidence level.
“Identifying seizures at the point-of-care is still a major challenge for hospitals of all sizes. This is especially critical for hospitals without 24/7 EEG coverage and for those that lack the resources for after-hours, weekend, and holiday coverage,” said Mark Lehmkuhle, Ph.D., Founder and Chief Executive Officer of Epitel. “With REMI Vigilenz AI For Bedside Notifications, clinicians will be notified of the occurrence of potential seizures, which can reduce time to treatment and improve outcomes for patients in the smallest of clinics to the largest of hospitals.”
The FDA granted clearance to REMI Vigilenz AI for Bedside Notifications with an authorized Predetermined Change Control Plan (PCCP). This new program allowed Epitel to introduce pre-approved performance-enhancing updates to the device without requiring additional FDA review. This clearance marked Epitel’s second AI/ML medical device approved by the FDA and its second device with an authorized PCCP, highlighting the company’s leadership in advancing brain health technology.
As per DelveInsight’s “Wearable Medical Devices Market Report”, the global wearable medical devices market is estimated to grow at a CAGR of 13.67% during the forecast period from 2024 to 2030. The wearable medical devices market is witnessing positive growth primarily owing to the rising prevalence of various chronic diseases such as cardiovascular, diabetes, pain, and others. Further, the rising burden of the geriatric population prone to various chronic diseases across the globe, the increasing awareness about fitness & physical activity, the increasing regulatory approval for wearable medical devices across the globe along with the presence of key players will in turn surge the demand of wearable medical devices during the forecast period. Therefore, the market for wearable medical devices is expected to grow during the forecast period from 2024 to 2030.
On October 18, 2024, SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage medical device company focused on developing proprietary solutions to mitigate hyperinflammation in vital organs, announced that it enrolled 51 subjects in its NEUTRALIZE-AKI pivotal trial, surpassing the halfway mark toward the target of 100 subjects required for conducting an interim analysis of the trial’s 90-day primary endpoint. The trial assessed the safety and efficacy of SeaStar Medical’s proprietary Selective Cytopheretic Device (SCD) in adults with acute kidney injury (AKI) in the intensive care unit (ICU) receiving continuous kidney replacement therapy (CKRT).
“The pace of enrollment in NEUTRALIZE-AKI has significantly accelerated from the summer lows, with the recent momentum driving us past the halfway point toward the planned interim analysis,” said Kevin Chung, MD, Chief Medical Officer of SeaStar Medical. “We have enrolled five subjects already in October, after enrolling only three in July and three in August. This current pace is encouraging as we work to activate additional clinical trial sites.”
SeaStar Medical’s SCD previously received U.S. Food and Drug Administration (FDA) breakthrough device designation for adults with AKI, which was awarded to a therapy to treat a serious or life-threatening condition with preliminary clinical evidence indicating it may demonstrate substantial improvement over available therapies on clinically significant endpoints. In July 2024, the Centers for Medicare & Medicaid Services granted Category B coverage for certain expenses incurred by medical centers when treating Medicare or Medicaid patients enrolled in NEUTRALIZE-AKI.
The NEUTRALIZE-AKI (NEUTRophil and monocyte deActivation via SeLective Cytopheretic Device – a randomized clinical trial in Acute Kidney Injury) pivotal trial was expected to enroll up to 200 adults at up to 30 clinical sites. The trial’s primary endpoint was a composite of 90-day mortality or dialysis dependency of patients treated with SCD in addition to CKRT as the standard of care, compared with the control group receiving only CKRT standard of care. Secondary endpoints included mortality at 28 days, ICU-free days in the first 28 days, major adverse kidney events at Day 90 and dialysis dependency at one year. The study also included subgroup analyses to explore the effectiveness of SCD therapy in AKI patients with sepsis and acute respiratory distress syndrome.
According to DelveInsight’s “Continuous Renal Replacement Therapy Machines (CRRT) Market Report”, the CRRT machines market was valued at USD 1.17 billion in 2023, growing at a CAGR of 7.38% during the forecast period from 2024 to 2030 to reach USD 1.78 billion by 2030. The CRRT machines market is experiencing significant growth due to the increasing instances of acute kidney injury and sepsis, coupled with advancements in technology and product launches which are acting as major factors contributing to the overall growth of the CRRT machines market during the forecast period from 2024 to 2030.
On October 21, 2024, Endospan, a pioneer in endovascular solutions for the Aortic Arch, announced that it completed enrollment for the primary arm of its TRIOMPHE Investigational Device Exemption (IDE) clinical study for the NEXUS® Aortic Arch Stent Graft. The study evaluated the safety and efficacy of the device for treating aortic arch disease.
The NEXUS Aortic Arch Stent Graft is a cutting-edge bi-modular off-the-shelf device designed to provide a minimally invasive solution for patients with aortic arch disease. The TRIOMPHE IDE study is a Three-Arm Non-Randomized Study conducted at 30 leading Aortic centers across the United States and one center in New Zealand, enrolling patients with a variety of aortic arch pathologies.
“We are thrilled to announce the completion of enrollment for the primary arm of this important clinical study,” said Kevin Mayberry, CEO of Endospan. “The NEXUS Aortic Arch Stent Graft has the potential to significantly improve outcomes for patients with aortic arch disease. We are committed to bringing this innovative technology, which is already a proven platform in Europe, to the US as quickly as possible.”
Brad Leshnower, MD from Emory who is the Cardiac National PI of the Study added, “We are excited to be part of this groundbreaking study. While the early results from the TRIOMPHE study presented at STS this year suggest that the NEXUS system can be used safely to treat aortic arch disease in a high-risk surgical cohort with a low rate of stroke, we anxiously await the results from the full cohort.”
According to DelveInsight’s “Aortic Aneurysm Stent Grafts Market Report”, the global aortic aneurysm stent grafts market growing at a CAGR of 5.71% during the forecast period from 2024 to 2030. The aortic aneurysm stent grafts market is witnessing positive growth owing to the increasing cases of patients suffering from aortic aneurysm and the growing aging population, rising regulatory approvals, rapid technological developmental activities. Further, an increase in the prevalence of cardiac diseases and growing awareness of these devices is thereby contributing to the growth of the aortic aneurysm stent grafts market during the forecast period from 2024 to 2030.
On October 18, 2024, Boston Scientific Corporation announced that it received U.S. Food and Drug Administration (FDA) approval for the navigation-enabled FARAWAVE™ NAV Ablation Catheter, intended for the treatment of paroxysmal atrial fibrillation (AF). The company also secured FDA 510(k) clearance for the new FARAVIEW™ Software, which, when combined, provided enhanced visualization for cardiac ablation procedures alongside the FARAPULSE™ Pulsed Field Ablation (PFA) System. These technologies were designed to be compatible exclusively with Boston Scientific’s existing cardiac mapping technology and its latest offering, the OPAL HDx™ Mapping System.
“The addition of the FARAWAVE NAV Ablation Catheter and FARAVIEW Software to our portfolio provides a next-level pulsed field ablation mapping experience with cost-effective tools developed specifically and uniquely for the FARAPULSE PFA System,” said Nick Spadea-Anello, president, Electrophysiology, Boston Scientific. “Built on this safe and clinically-proven platform – which has been used to treat more than 125,000 patients globally – the visualization capabilities offered by these new technologies are designed to increase confidence in therapy delivery and simplify mapped workflows during PFA procedures.”
“In clinical use, the FARAVIEW Software and FARAWAVE NAV Ablation Catheter produced detailed cardiac maps that could improve guidance, limit fluoroscopy times and assist physicians in assessing the location of energy delivered during PFA procedures,” said Vivek Reddy, M.D., director of electrophysiology, Mount Sinai Fuster Heart Hospital, New York. “The addition of navigation and visualization capabilities to the FARAPULSE PFA System could aid workflow efficiency and enhance the treatment physicians can provide to patients living with AF.”
The FARAWAVE NAV Ablation Catheter enhanced the existing FARAWAVE catheter by incorporating magnetic navigation capabilities, allowing for cardiac mapping and pulsed field ablation (PFA) therapy to be delivered through a single integrated device, reducing the need for additional equipment. During mapped procedures with the FARAPULSE PFA System, physicians could view catheter placement, shape, and rotation through the FARAVIEW Software. This latest update in Boston Scientific’s PFA portfolio tracked the FARAWAVE NAV Ablation Catheter magnetically, enabling doctors to see where pulsed fields were applied and visualize the cumulative therapy delivered to guide their ablation strategy. The catheter’s automated tagging technology helped physicians plan, execute, and confirm therapy applications by indicating approximate pulsed field locations within the heart based on the catheter’s position.
According to DelveInsight’s “Cardiac Mapping System Market Report”, the global cardiac mapping system market was valued at USD 1.99 billion in 2023, growing at a CAGR of 8.99% during the forecast period from 2024 to 2030, to reach USD 3.07 billion by 2030. The rising prevalence of cardiac disorders such as arrhythmias, atrial fibrillation, and ventricular tachycardia, is fueling the growth of the cardiac mapping system market. These systems are essential for early diagnosis and treatment, offering real-time images of heart electrical activity to prevent serious complications such as stroke and heart failure. Additionally, the increasing preference for minimally invasive procedures, such as catheter ablation, which rely heavily on advanced cardiac mapping systems to ensure success. Furthermore, continuous advancements in technology and increased product development activities by key market players are enhancing the capabilities of cardiac mapping systems, making them more efficient, user-friendly, and widely accessible. Together, these factors are expected to increase the demand for cardiac mapping systems across the globe during the forecast period from 2024 to 2030.
On October 21, 2024, GE HealthCare announced the launch of CareIntellect for Oncology, a new cloud-first application that integrated multi-modal patient data from various systems into a single view, utilizing generative AI to summarize clinical notes and reports. The application highlighted relevant data, enabling care teams to quickly understand disease progression and identify potential deviations from treatment plans, assisting clinicians in determining possible next steps and informing proactive interventions. Scheduled to be available to customers in the U.S. the following year, the application initially targeted prostate and breast cancer.
It organized both structured and unstructured data (such as medical images, records, notes, and device readings), summarized complex medical histories, supported treatment response assessments, evaluated clinical trial eligibility, and monitored adherence to treatment protocols in an easy-to-navigate format. This marked the first application within GE HealthCare’s new CareIntellect suite of clinical and operational tools, designed to facilitate the quick and easy installation of new applications without the need for a costly and time-consuming integration process for each product.
CareIntellect for Oncology quickly organizes multi-modal patient data from disparate systems to provide care teams with a concise view of the patient’s progressive treatment journey, while allowing clinicians to maintain full access to the source reports. The application will allow care teams to reduce or eliminate the time-consuming task of searching multiple databases—reducing a process that can take several hours, down to several minutes by eliminating the need to track down and synthesize information across multiple reports. The application is also able to flag risk of deviation from the treatment plan, helping the clinician determine potential next steps to intervene—for example, surfacing a patient’s missed lab work that could delay the next round of treatment. Additionally, CareIntellect for Oncology helps care teams assess potentially suitable clinical trials by comparing the patient’s health record to trial criteria.
“Currently only 3% of hospital data is used because of the complexities associated with organizing and extracting useful healthcare insights at scale. Yet there is so much potential to turn the other 97% into actionable data to advance healthcare, but it is critical that any new technologies we develop be efficient and easy to use while reducing cognitive burdens for clinicians and removing implementation hurdles for providers,” said Dr. Taha Kass-Hout, Global Chief Science and Technology Officer at GE HealthCare. “CareIntellect is designed to help providers streamline access to critical patient information and surface key changes since the patient’s last visit. By ensuring the provider has the right information at their fingertips, they can spend less time sifting through information and more time helping patients.”
“Tampa General Hospital is looking forward to evaluating CareIntellect for Oncology to provide our care teams with information to move from analysis to action—including making use of the proactive pathways to inform care progression and clinical trial eligibility information,” said Dr. Peter Chang, Senior Vice President, Chief Transformation Officer at Tampa General Hospital. “We were impressed by how quickly GE HealthCare was able to design the application to include breast cancer in a matter of weeks. We look forward to putting this in the hands of our care teams and using the AI-enabled functionality to help clinicians spend time where it matters most—delivering outstanding patient care.”
According to DelveInsight’s “Artificial Intelligence (AI) In Cancer Diagnostics Market Report”, the global cardiac mapping system market was valued at USD 1.1 billion in 2023, growing at a CAGR of 21.4% during the forecast period from 2024 to 2030, to reach USD 9.0 billion by 2030. The market for Artificial Intelligence (AI) in cancer diagnostics is driven by several key factors. Firstly, the increasing incidence of cancer globally has heightened the demand for more efficient and accurate diagnostic solutions. AI technologies enhance the ability to analyze complex medical data, such as medical images and genomic profiles, leading to faster and more precise detection of various cancer types. Additionally, the growing emphasis on personalized medicine encourages the development of AI tools that can tailor diagnostic approaches to individual patient profiles, improving treatment outcomes. Advances in machine learning algorithms and the availability of large datasets for training these models further propel innovation in this sector. Moreover, the integration of AI in healthcare systems is supported by favorable government initiatives and funding aimed at improving cancer care, is expected to make AI a crucial component in modern oncology diagnostics during the forecast period from 2024 to 2030.
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