Viz.ai is First to Receive FDA 510(k) Clearance for AI Algorithm for Abdominal Aortic Aneurysm

On March 21, 2023, Viz.ai, the leader in AI-powered disease detection and intelligent care coordination, announced it had received U.S. Food and Drug Administration (FDA) 510(k) clearance for its algorithm intended to detect suspected abdominal aortic aneurysm (AAA). Viz AAA is the first FDA-cleared AI-powered solution for the detection and triage of suspected AAA.

Viz AAA uses artificial intelligence to automatically search for the presence of an abdominal aortic aneurysm from computed tomography angiography (CTA) from any scanner in a hospital network. The new artificial intelligence (AI) algorithm and clinical workflow solution will be a part of the Viz™ AORTIC Module, an AI solution designed to accelerate treatment decisions for all aortic pathology.

“An estimated 1.1 million Americans are living with an AAA1. Most of these patients are asymptomatic, and many are unaware of their disease until a rupture occurs. This is a catastrophic medical emergency, resulting in over 10,000 deaths each year. This algorithm is a powerful new tool for healthcare professionals to more readily identify and capture individuals with AAA and, importantly, automatically refer those at imminent risk for rupture.”

Philip Batista, MD, Associate Program Director, Vascular, and Endovascular Surgery Residency

AAA is an important and actionable incidental finding that is too often missed. The vision behind Viz AAA is to automatically catch and follow abdominal aortic disease, no matter the patient’s location. We believe that this product will enable care teams to prevent catastrophic aortic emergencies, such as aortic rupture, by increasing the surveillance of these patients.

Jayme Strauss, chief clinical officer at Viz.ai

An abdominal aortic aneurysm is a bulge in the abdominal aorta, the main artery that carries blood from the heart to the rest of the body. If left undetected and untreated, AAA can lead to a rupture, which can often be fatal. As per DelveInsgiht, the total diagnosed prevalent population of Abdominal Aortic Aneurysms in 7MM was estimated to be 1,641,380 cases in 2021 and is expected to increase in the coming years. Furthermore, more than 10,000 deaths occur yearly in the United States alone due to AAA. The Viz’s AI-based software is anticipated to detect suspected abdominal aortic aneurysms (AAA) and hold the potential to provide a better outcome for the affected patients. The software can be integrated into existing hospital workflows, allowing physicians to quickly and easily identify patients who may have a suspected AAA and take appropriate measures to prevent a rupture.

BrainTale Unveils the New Version of Its Digital Biomarkers Platform brainTale-care CE-marked under the MDR 2017/745

On March 22, 2023, BrainTale announced the new release of its CE-marked version of the brainTale-care digital biomarker platform under European regulation MDR 2017/745. The version of the brainTale-care digital biomarker platform is now available to all users, this new release is expected to offer significant improvements with some additional new features, including new capabilities for patient monitoring, enhanced data, and platform security, as well as optimized usage with automation and integration with integrated data flows.

Long underestimated in neuroscience, white matter, which represents 80% of the human brain, plays a key role in its proper functioning, development, and aging, whether normal or pathological. As a result, since its inception in 2018, BrainTale has been developing non-invasive, accessible, effective, and clinically validated measurement and prediction solutions for physicians treating patients with brain diseases. Two modules are available on the brainTale-care platform: brainQuant measuring quantitative, objective, and reproducible white matter lesions non-invasively, and brainScore-coma, dedicated to the prediction of coma recovery.

“This new version of brainTale-care is an important improvement for all our users, with superior security and usability alongside additionally available biomarkers. It is a significant enrichment of the platform’s features, to allow its deployment to a growing number of customers for the benefit of patients and industrial players”.

Jean-Baptiste Martini, Chief Technical Director

As per the updates from BrainTale, the three key features improvements are being available to customers include – 

  • Enhanced security of the software medical device: higher data security, data flows, and optimized cybersecurity.
  • Access to additional biomarkers targeting axons and myelin integrity for improved care in neurology is now available in clinical reports.
  • Additionally, it provides improved usability, which will lead to an automation of data flows with the medical imaging management system (PACS)

Beyond the renewal of the ISO13485 certification obtained in early 2023, this significant update of the brainTale-care platform supports the growth and development of BrainTale’s solutions of white matter biomarkers for drug development and real-life environments.

Medtronic and NVIDIA Announce Medical Device Collaboration

GTC— NVIDIA announced a partnership with Medtronic, the world’s largest healthcare technology provider, to accelerate the development of artificial intelligence in the healthcare system and bring new AI-based solutions into patient care.

NVIDIA healthcare and edge AI technologies will be integrated into Medtronic’s GI GeniusTM intelligent endoscopy module, developed and manufactured by Cosmo Pharmaceuticals. GI Genius is the first FDA-approved artificial intelligence-assisted colonoscopy tool to assist physicians in detecting polyps that can lead to colorectal cancer. The NVIDIA ClaraTM healthcare platform could allow Medtronic to scale the development of algorithms for real-time procedures, potentially accelerating AI innovation for better patient care.

“Artificial intelligence is a powerful tool that can increase the speed, efficiency and effectiveness of global health systems. We’re collaborating with Medtronic to accelerate AI innovation by enabling a software-defined business model, with the goal of improving clinical decision-making, reducing medical variability, and driving better patient outcomes.”

Kimberly Powell, vice president of healthcare at NVIDIA

“We believe that collaborating with AI companies and developers like NVIDIA and Cosmo is essential to driving innovation within the medical device industry. We are committed to working with the best and brightest minds in the field of AI to develop new technologies that can improve patient outcomes and transform the way we approach healthcare.”

Giovanni Di Napoli, president of Gastrointestinal Business at Medtronic

Medtronic plans to use NVIDIA Holoscan, a real-time AI computing software platform for building medical devices, and NVIDIA IGX, an industrial-grade edge AI hardware platform, in conjunction with its GI Genius AI-assisted colonoscopy system to provide physicians with AI-enhanced diagnostic images. Holoscan contributes to the clinical adoption of cutting-edge AI applications by providing the full-stack infrastructure required for scalable, software-defined processing of streaming data at the edge.

The NVIDIA Holoscan and IGX platform enables developers to efficiently train and validate AI models within the Cosmo Innovation Center, and then host the AI-powered applications on Medtronic’s GI Genius AI Access Platform, a marketplace for software-as-a-medical-device (SaMD) applications.

Median Technologies Announces Completion of the Q-Submission Phase with the FDA for its iBiopsy® Lung Cancer Screening CADe/CADx Software as Medical Device

Median Technologies announced that it has received feedback from the US Food and Drug Administration (FDA) regarding the Q-submission phase for its iBiopsy® Lung Cancer Screening (LCS) AI/ML tech-based CADe/CADx1 Software as Medical Device (SaMD), which began on May 2, 2022, and that it has completed this phase.

The Q-submission phase is a significant regulatory step that allows for regular and in-depth discussions with the FDA on critical topics like pivotal study protocols. Following the Q-submission phase, Median’s SaMD is better tailored to meet the FDA’s and market needs.

Following the completion of all imaging and clinical data collection and preparation, as well as reader training, Median Technologies is now getting ready for pivotal study execution by the end of Q2 2023, as planned. Similarly, Median continues to aim for FDA 510(k) clearance for its iBiopsy® LCS CADe/CADx SaMD in the first half of 2024, subject to FDA review requirements.

“We were able to have frequent and fruitful interactions with the Agency during the Q-submission phase in order to better tailor our medical device software to the US market. But, more importantly, we had the opportunity to present to the FDA our vision for our product, the cutting-edge performance we seek, and our ambition to change the paradigm in the early diagnosis of lung cancer patients,”

Fredrik Brag, CEO and Founder of Median Technologies

iBiopsy® is built on the most advanced Artificial Intelligence (AI) and Data Science (DS) technologies, as well as Median’s expertise in medical image processing. iBiopsy® seeks to develop AI/ML technology-based Software of Medical Devices (SaMD) for use in a variety of indications where there are unmet needs for early diagnosis, prognosis, and treatment selection in the context of precision medicine. Currently, iBiopsy® is focused on lung cancer, liver cancer (HCC), and liver disease (NAFLD/NASH).

ObvioHealth to Conduct a Pioneering Decentralized Clinical Trial on the Mi-Helper Device for Treatment of Migraine

On Mar 16, 2023, ObvioHealth and Mi-Helper, Inc. entered into a partnership to conduct a decentralized clinical trial for a non-invasive neuromodulation device for the treatment of migraines. The randomized controlled trial will be fully remote, enabling data capture from home where the device is intended to be used.

The tiny Mi-Helper device relieves migraine-related pain and related symptoms like nausea and photosensitivity by delivering a controlled stream of conditioned air with a nebulized mist to the mucosa membranes in the nose.

A pivotal trial to assess therapeutic efficacy will be followed by the establishment of optimal dosing in the Mi-Helper study, which has an adaptive design. Patients will be able to remotely enroll, give their consent, and report relief from pain and other migraine symptoms, the use of rescue medications, and any potential negative events using the ObvioGo app. The COACH (Clinical Oversight And Coordination Hub) team at ObvioHealth will remotely monitor patient safety and compliance in close to real time. The study is expected to begin recruiting this summer.

“We are working with the top headache neurologists in the world to inform our clinical studies. We are committed to delivering a paradigm shift for migraine treatment—fast, accessible, and affordable relief for this highly complex and debilitating neurological disease.”

Steve Schaefer, CEO of Mi-Helper. Steve

“Mi-Helper and ObvioHealth are dedicated to inclusivity. By designing a decentralized clinical trial without the need for physical site visits, we can recruit patients anywhere in the continental United States, including underserved communities. This will provide Mi-Helper with essential data on a real-world population in a real-world setting and should help to ensure that the device, when launched, can serve a broad population.”

Ivan Jarry, CEO of ObvioHealth

As per DelveInsight Analysis, “Neuromodulation Devices – Market Insights, Competitive Landscape, and Market Forecast – 2027”, the global neuromodulation devices market was valued at USD 5.71 billion in 2021, growing at a CAGR of 8.95% during the forecast period from 2022 to 2027 to reach USD 9.56 billion by 2027. The demand for neuromodulation devices is primarily driven by the rising prevalence of neurological disorders along with the aging population, the expansion of the devices to other chronic indications and target applications, the advancement of technology in the product line, and rising government initiatives to increase patient awareness of neurological disorders, among other factors.

Vectorious Reported Promising Findings From its Pilot Study

On Mar 21, 2023, Vectorious Medical Technologies Ltd. presented interim results from its Left Atrial Pressure (LAP) Guided, Patient Self-Management (PSM) pilot study during a featured abstract session at THT 2023 in Boston. 

The study, which has enrolled 13 patients to date, includes people with New York Heart Association (NYHA) class II and class III HF who have the V-LAP sensor implanted in the left atrium, regardless of their left ventricular ejection fraction. Patients who use a dedicated app and novel treatment paradigm for self-management of diuretics and early intervention in cases of high LAP can see direct LAP readings taken by the sensor.

Patients with heart failure can manage their condition more actively thanks to the V-LAP System. Patients can better understand the relationship between their daily medication schedule, daily activities, and fluid volume status by using the V-LAP System. Patients are instructed to modify their diuretics in accordance with the predetermined treatment plan when LA pressure is outside of the ideal range. The medical team is informed if the LA pressure is below optimal levels and can offer additional instructions to stop further deterioration.

Results:

  • Over an average follow-up of 9.14 months (278 days; range 93-412 days), patient adherence (defined as ≥ 5 days of LAP measurements per week) was 91.36%. 
  • During 89.1% of the overall follow-up duration (9.6 patient-years, 3504 total days), PSM alone was used to keep heart failure patients within the optimal LAP range, while in only 10.9% of overall follow-up time, physician intervention was required to further adjust medication dosage due to persistently high LAP. 
  • Using the PSM approach, a significant decrease in the annualized rate of HF-related hospitalizations was observed compared to a similar period prior to PSM utilization (0 admissions per patient under PSM versus 0.69 admissions per patient prior to PSM, P=0.004). 
  • PSM patients demonstrated significant improvement in 6-minute walk distance from a median of 187.00m (IQR 178.00-325.00m) at baseline to 325.00m (IQR 235.00-425.00m) at 6 months, P=0.047. 
  • The Kansas City Cardiomyopathy Questionnaire score was also significantly improved from baseline to 6 months. (median 49.22, IQR 36.4-52.08, to 68.75, IQR 53.91-86.46, P=0.031).

“These initial insights represent the next frontier of hemodynamic monitoring by enabling patients to self-manage their LAP under the direction of their physician’s prescribed guidelines,” said Dr. William T. Abraham M.D., College of Medicine Distinguished Professor at The Ohio State University, who presented the results at the THT meeting. Dr. William also said, “Over the past decade, physician directed hemodynamic management using pulmonary artery pressure sensors has demonstrated the benefits of pressure-guided HF care. Based on randomized controlled trials, these devices are now indicated for NYHA class II and III heart failure patients for prevention of readmissions due to heart failure exacerbations. Next generation LA sensors enable this paradigm to further evolve to physician directed, patient self-management. While larger randomized controlled studies are required to confirm the effectiveness of this approach, it has the potential to revolutionize the field and have clinical impact on millions of HF patients.”

Vectorious CEO and co-founder Eyal Orion, MD, said, “We strongly believe that the unique data from the LA, coupled with our technological platform will enable millions of HF patients to take ownership of their disease.” Eyal Orion further added, “Using the insights we get from the left atrium, we continue to learn about the disease and optimize our treatment paradigm to tailor personalized treatment to the individual patient. We believe that implantable sensors, that can provide long term accurate physiological information, will play major role in treatment of patients with chronic diseases and development of novel therapeutic approaches.”

As per DelveInsight’s “Congestive Heart Failure (CHF) Treatment Devices Market” report, the global congestive heart failure (CHF) treatment devices market was valued at USD 17.41 billion in 2021, growing at a CAGR of 8.26% during the forecast period from 2022 to 2027 to reach USD 127.96 billion by 2027. Owing to the increasing prevalence of cardiovascular diseases (CVDs), a surge in product development research and development activities, and an aging population that is more susceptible to these diseases, the market for congestive heart failure (CHF) treatment devices is expanding favorably. Additionally, the extreme benefits of these devices in treating heart failure cases and the rising acceptance of minimally invasive procedures had further pushed for the demand for these devices, fueling the expansion of the congestive heart failure (CHF) treatment devices market during the forecast period from 2022 to 2027.