Notizia - Recent Pharma, Healthcare and Biotech Happenings
Mar 13, 2025
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Caristo Diagnostics, focused on transforming the diagnosis and treatment of cardiovascular disease, has announced that its CaRi-Plaque technology has received 510(k) clearance from the FDA. CaRi-Plaque is an AI-powered image analysis tool designed to support the diagnosis of coronary artery disease (CAD).
Coronary inflammation leads to plaque buildup in the arteries, often without symptoms, until it causes heart attacks or strokes. Fatty plaque deposits weaken the artery walls over time, and while medications like statins and blood pressure drugs can slow this process, many heart attacks occur in arteries that were not significantly narrowed beforehand. This is because inflammation can destabilize plaques, causing them to rupture and block the artery. Effective prevention of heart disease requires identifying both plaque buildup and underlying inflammation early on.
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CaRi-Plaque enables non-invasive analysis of coronary anatomy and disease severity using routine coronary computed tomography angiography (CCTA) scans. It assesses the presence, extent, and severity of coronary plaques and artery narrowing. Built on Caristo’s CaRi-Heart® technology—validated in a 2024 Lancet study for predicting heart attacks up to a decade in advance—CaRi-Plaque provides cardiologists and radiologists with a clearer picture of a patient’s heart health risks.
“For years, heart disease has been treated reactively—after symptoms appear,” said Frank Cheng, CEO of Caristo Diagnostics. “FDA clearance for CaRi-Plaque allows hospitals and clinics to shift toward proactive, personalized prevention. By detecting both plaque buildup and hidden inflammation, we’re helping doctors identify high-risk patients sooner, refine treatments, and ultimately save lives. This marks a major step toward redefining cardiac care.”
Dr. Stephen A. Bloom, cardiologist and Director of Advanced Imaging at Midwest Heart & Vascular Specialists in Kansas City, described CaRi-Plaque as a breakthrough in coronary disease prevention. “This technology allows us to diagnose coronary disease even before calcium scores become positive, opening the door for earlier interventions. We’re excited to work with Caristo to expand clinical use.”
The CaRi-Plaque analysis process is straightforward for healthcare providers. CT scan data can be uploaded to the cloud with a single click. Caristo anonymizes the data before analyzing the images using its AI software. Trained operators then review the results and deliver a detailed CaRi-Plaque Report in DICOM or PDF format to the healthcare provider.
Dr. John Simon, CEO of SimonMed Imaging, emphasized the potential impact: “With advanced AI tools like CaRi-Plaque and the growing number of available treatment options, we have the potential to prevent hundreds of thousands of heart attack and stroke-related deaths each year. We look forward to collaborating with Caristo to drive earlier and more accurate detection of coronary inflammation.”
CaRi-Plaque’s accuracy has been validated through a multi-center, international study, confirming consistency between CaRi-Plaque’s findings and expert clinical assessments. The technology will be covered under the American Medical Association’s new Category I CPT code, 75XX6, starting in January 2026. Until then, it will be billed under Category III CPT codes (0623T–0626T).
Lindus Health, known for conducting faster and more reliable clinical trials for life sciences companies, has partnered with Sooma Medical, a leading provider of brain stimulation treatments for psychiatric and neurological conditions. Together, they will conduct a Phase III clinical trial to assess the effectiveness of Sooma’s transcranial direct current stimulation (tDCS) device, Sooma 2GEN, in treating symptoms of major depressive disorder (MDD) as a home-based therapy. The device, worn as a cap, delivers low-level electrical currents to the brain through electrodes, offering a non-invasive treatment option.
MDD affects approximately 8.3% of adults in the US and is one of the most common psychiatric disorders, contributing significantly to disability and negatively impacting physical health and relationships. tDCS therapy provides a promising alternative for patients who have not responded to antidepressants, with no significant side effects, drug interactions, or risk of dependency.
The trial will involve around 200 participants across the US. Lindus Health will use its virtual site capabilities, including in-house medical monitoring and digital advertising for patient recruitment. Their proprietary eClinical platform, Citrus™, will support patient pre-screening, virtual consultations, patient-reported outcomes, and overall study management.
Michael Young, co-founder of Lindus Health, highlighted the importance of exploring new treatment options, stating, “No single therapy works for all patients. Partnering with Sooma to introduce a new treatment for MDD is an exciting opportunity.” Tuomas Neuvonen, co-founder and CEO of Sooma, noted that many patients classified as “treatment-resistant” have limited options. He emphasized that Sooma 2GEN offers an effective and accessible solution, adding, “We’re thrilled to collaborate with Lindus Health to generate US-based data demonstrating the device’s potential to improve life for depression patients.”
Sooma 2GEN has already been approved for MDD treatment in several European countries, but no tDCS-based device has yet gained approval in the US. Positive trial outcomes would validate the device’s safety and efficacy, supporting its clinical approval for MDD in the US.
GT Metabolic Solutions, Inc., a global leader in magnetic surgery, has received FDA clearance for a larger 50mm MagDI™ System magnet, complementing its existing 40mm version. This expansion allows surgeons to accommodate a broader patient population in magnet-assisted duodenal-ileal anastomosis procedures. The clearance reinforces GT Metabolic’s dedication to advancing innovative, minimally invasive surgical solutions that enhance patient outcomes.
The MagDI System remains the only FDA-cleared and commercially available technology for magnetic compression anastomosis. Designed as a self-aligning, incisionless, sutureless, and staple-free solution, it streamlines anastomosis procedures while eliminating the need for permanent foreign materials. With the introduction of the 50mm magnet, the MagDI System now provides surgeons with greater flexibility in tailoring procedures to individual patient needs, further improving surgical efficiency and outcomes.
“I’m pleased with my early experience using the MagDI System,” said Phil Gachassin, MD, MHCM, Medical Director of Metabolic and Bariatric Surgery at Ochsner Lafayette General Medical Center. “The results have been promising, and I’m especially impressed with how my patients are responding to the magnetic compression anastomosis technique.” Dr. Gachassin and his team were among the first in Louisiana to use the system with the 40mm magnet.
GT Metabolic’s leadership emphasized the significance of this expansion in advancing magnetic surgery. “This expansion reinforces our commitment to pushing the boundaries of minimally invasive surgery and providing surgeons with advanced tools to improve patient outcomes,” said Thierry Thaure, Chief Executive Officer and co-founder. Chief Medical Officer and co-founder Michel Gagner, MD, added, “The clinical success we’ve seen so far highlights the role of magnetic compression in bariatric surgery. The addition of the 50mm magnet allows us to broaden the impact of the MagDI System.”
As demand for minimally invasive surgical techniques grows, GT Metabolic remains focused on accelerating the U.S. market release of the MagDI System in collaboration with leading surgeons and hospitals. Clinical data continues to support the effectiveness of this approach, with no reported leaks or bleeds linked to the sutureless, staple-free technique.
DelveInsight’s Anastomosis Device Market report provides a comprehensive analysis of the evolving landscape, highlighting key advancements in surgical anastomosis techniques, market trends, and emerging players. With innovations like GT Metabolic’s MagDI System, the anastomosis device market is witnessing significant growth as healthcare providers seek safer, more efficient solutions for surgical procedures.
Beckman Coulter Diagnostics, a global leader in clinical diagnostics, has received 510(k) clearance from the FDA for its DxC 500i Clinical Analyzer, an integrated clinical chemistry and immunoassay analyzer. Designed to support laboratories of all sizes, the DxC 500i combines advanced technology with an intuitive interface to streamline operations and enhance diagnostic efficiency. With a throughput of up to 800 clinical chemistry tests and 100 immunoassay tests per hour, the system ensures precise and reliable results, critical for timely clinical decision-making and improved patient care.
As healthcare systems increasingly transition to networked laboratory models, laboratory efficiency and scalability have become key priorities. In the United States, approximately 45% of clinical laboratories—over 11,000 labs—are now part of an Integrated Delivery Network (IDN), which allows for more coordinated and efficient healthcare services. IDNs optimize resource management, standardize diagnostic practices, and improve patient outcomes through centralized testing strategies. The DxC 500i is tailored to meet the needs of these networked laboratories, providing a standardized solution for both satellite and core laboratory operations.
“Innovations like the DxC 500i Clinical Analyzer enable Beckman Coulter to address the needs of networked laboratories with specific solutions for satellite, independent, and core laboratories,” said Kathleen Orland, Chief Portfolio Officer for Beckman Coulter Diagnostics. “Beyond ensuring appropriate throughput levels, Beckman Coulter’s common reagents and consumables across its scalable chemistry and immunoassay portfolio provide IDNs with strategic advantages in patient care and inventory management.”
The DxC 500i Clinical Analyzer features FlexMode operations, allowing laboratories to prioritize immunoassay and chemistry testing based on each sample’s urgency. Its dynamic sample handler streamlines workflow by automatically managing repeats and re-runs without the need for operator intervention. The system’s compact design enables high throughput without compromising space, while its intuitive interface includes proactive task indicators and step-by-step instructions, making it easy to onboard and train laboratory staff efficiently.
The DxC 500i has been available in countries accepting the CE mark since July 2024, reinforcing its credibility in global markets. It builds upon the technology of Beckman Coulter’s DxC 500 AU Chemistry Analyzer, which features onboard guided workflows, more than 120 assays, and standardized reagents. Incorporating Six Sigma performance standards, the DxC 500i is designed to meet the growing demands of modern laboratories while ensuring accuracy and consistency across healthcare networks.
Not all products are available in all countries, as regulatory approvals vary. Beckman Coulter remains committed to expanding access to advanced diagnostic solutions, supporting healthcare providers with scalable, efficient, and innovative laboratory technologies that drive better patient outcomes.
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