NEWS Methinks AI expands stroke detection solution into contrast imaging with second US FDA clearance Methinks has received FDA 510(k) clearance for Methinks computed tomography angiography (CTA) Stroke, an artificial intelligence (AI)-based software solution intended to accurately detect suspected large vessel occlusions (LVOs) using CTA scans. This marks the company’s second FDA 510(k) clearance of 2025 after its non-contrast computed tomography (NCCT) Stroke software gained approval from the US regulator in July. “We’re proud to have achieved our second US FDA clearance this year, a milestone that reflects the strength and maturity of our regulatory team and processes,” said Methinks chief executive officer (CEO) Pau Rodríguez. “This accomplishment demonstrates our ability to deliver advanced, accessible stroke care solutions across US hospitals.” Congrats for this big milestone Pau and team! https://lnkd.in/d7wXuAf9 #wearenina
Nina Capital’s Post
More Relevant Posts
-
Vektor Medical, Inc. announced it has received CE mark certification for vMap, its AI-developed solution that uses standard 12-lead electrocardiogram (ECG) data to map the source of arrhythmias across all four chambers of the heart. https://lnkd.in/djYj3Sh8 #AI #artificialintelligence #cardiology #diagnostics #digitalhealth #healthIT #healthtech #productapprovals #regulatoryaffairs
To view or add a comment, sign in
-
SAN DIEGO--(BUSINESS WIRE)--Vektor Medical, a medical technology company transforming cardiac arrhythmia care, announced it has received CE Mark for the vMap® System, a non-invasive tool developed with AI that transforms standard 12-lead ECG data into
To view or add a comment, sign in
-
Vektor Medical, Inc. received CE Mark approval for vMap, its non-invasive, AI-powered mapping system that transforms standard 12-lead ECG data into 3D visualizations of arrhythmia sources in under a minute. ⚡️ Already FDA-cleared and used in more than 2,000 procedures across the U.S., vMap enhances ablation accuracy, efficiency, and clinical decision-making. CEO Rob Krummen commented: "With regulatory approvals now in place in the U.S. and Europe, we’re well positioned to accelerate adoption and expand access to this innovation globally.” 🙌 🔗 Read the full announcement: https://lnkd.in/d3dXwZFx 📰 Want the latest #MedTech updates straight to your inbox? Subscribe to our newsletter: https://lnkd.in/dUezyiDN #MedTech #MedTechNews #Cardiology #DigitalHealth
To view or add a comment, sign in
-
DAS medhub Chest Expert Model – AI-Powered Chest X-Ray Reporting The DAS medhub Chest Expert Model is a next-generation AI diagnostic support system built to empower radiologists and healthcare professionals with fast, reliable chest X-ray interpretation. Capable of running fully offline without the need for heavy cloud infrastructure, the model is lightweight, efficient, and deployable even in low-resource environments. This makes it ideal for hospitals, diagnostic centers, and clinics where stable internet or expensive hardware setups may not be available. Abnormalities Detected (14) ▪️ Aortic Enlargement ▪️ Atelectasis ▪️ Calcification ▪️ Cardiomegaly ▪️ Consolidation ▪️ Interstitial Lung Disease (ILD) ▪️ Infiltration ▪️ Lung Opacity ▪️ Nodule/Mass ▪️ Other Lesion ▪️ Pleural Effusion ▪️ Pleural Thickening ▪️ Pneumothorax ▪️ Pulmonary Fibrosis Report Structure Each chest X-ray analysis generates a structured, radiology-standard report that includes: ▪️ Findings: AI-detected abnormalities with confidence scores. ▪️ Impression: Clear summary highlighting the most significant abnormalities. ▪️ Recommendations: Suggested next steps such as CT/HRCT scans, echocardiography, PFTs, or clinical correlation. Key Advantages ✔ Works 100% offline – no internet dependency. ✔ No need for huge server setups or expensive cloud infrastructure. ✔ Produces instant, expert-style radiology reports. ✔ Designed for radiologists and healthcare professionals only – not intended for direct patient use. 🔗 Try the DAS medhub Chest Expert Model here: https://lnkd.in/gxjZJvRk
To view or add a comment, sign in
-
Transforming radiology with AI – DAS medhub ChestExpert delivers instant, offline chest X-ray reports detecting 14 key abnormalities with expert precision.
DAS medhub Chest Expert Model – AI-Powered Chest X-Ray Reporting The DAS medhub Chest Expert Model is a next-generation AI diagnostic support system built to empower radiologists and healthcare professionals with fast, reliable chest X-ray interpretation. Capable of running fully offline without the need for heavy cloud infrastructure, the model is lightweight, efficient, and deployable even in low-resource environments. This makes it ideal for hospitals, diagnostic centers, and clinics where stable internet or expensive hardware setups may not be available. Abnormalities Detected (14) ▪️ Aortic Enlargement ▪️ Atelectasis ▪️ Calcification ▪️ Cardiomegaly ▪️ Consolidation ▪️ Interstitial Lung Disease (ILD) ▪️ Infiltration ▪️ Lung Opacity ▪️ Nodule/Mass ▪️ Other Lesion ▪️ Pleural Effusion ▪️ Pleural Thickening ▪️ Pneumothorax ▪️ Pulmonary Fibrosis Report Structure Each chest X-ray analysis generates a structured, radiology-standard report that includes: ▪️ Findings: AI-detected abnormalities with confidence scores. ▪️ Impression: Clear summary highlighting the most significant abnormalities. ▪️ Recommendations: Suggested next steps such as CT/HRCT scans, echocardiography, PFTs, or clinical correlation. Key Advantages ✔ Works 100% offline – no internet dependency. ✔ No need for huge server setups or expensive cloud infrastructure. ✔ Produces instant, expert-style radiology reports. ✔ Designed for radiologists and healthcare professionals only – not intended for direct patient use. 🔗 Try the DAS medhub Chest Expert Model here: https://lnkd.in/gxjZJvRk
To view or add a comment, sign in
-
Medical imaging technology continues to evolve, with Izotropic Corporation leading innovative approaches to diagnostic scanning. The company's IzoView breast CT system represents a significant advancement in radiology, focusing on delivering high-resolution 3D images while minimizing patient radiation exposure. The Centers for Medicare & Medicaid Services (CMS) recently proposed keeping CT radiation quality tracking voluntary through 2027, highlighting the complex landscape of medical imaging standards. This decision reflects the ongoing challenges healthcare providers face in implementing comprehensive radiation monitoring protocols. Izotropic's purpose-built approach addresses critical industry needs by engineering imaging technology that balances diagnostic precision with patient safety. Their commitment to developing low-dose, high-resolution scanning solutions positions them at the forefront of medical imaging innovation. As healthcare technology continues to advance, companies like Izotropic are demonstrating that improved patient outcomes can be achieved through thoughtful technological design and a patient-centric approach to medical diagnostics.
To view or add a comment, sign in
-
Moe Alsumidaie’s latest article examines why site-level mistakes in applying tumor response criteria hinder oncology studies, how late corrections result in patient censoring, protocol violations, and millions of dollars in delays, and why the industry must prioritize quality upstream. Be sure to check out the full article here: https://lnkd.in/eS2juD5U #ClinicalTrials #OncologyResearch #ClinicalResearch #Pharma #LifeSciences #MedicalImaging #DrugDevelopment #HealthcareInnovation #DataIntegrity #GoodClinicalPractice
Imagine spending millions on a clinical trial only to discover that the imaging errors you thought were “fixed” at central review have already skewed the data beyond repair. That’s the reality many sponsors face today. In oncology, for example, more than 30% of imaging reads contain errors—and when they’re only caught at central review, the damage is done. Correcting them at that stage can add months of delays and millions in costs, with no guarantee of salvaging trial integrity. The smarter path is earlier intervention. Instead of waiting until central review, trial leaders need real-time visibility into imaging data. That means empowering sites with immediate feedback, building traceability from pixel to measurement, and reducing reliance on post-hoc fixes that drain both timelines and budgets. It’s not just about cost. It’s about trust. Regulators, investigators, and—most importantly—patients depend on imaging data to reflect reality. When errors linger unchecked, confidence in the trial erodes. The industry can’t afford to let imaging errors hide until the end. How do you see sponsors and CROs addressing this challenge—are we ready to make imaging oversight proactive instead of reactive? Full article here: https://lnkd.in/dxm6zstj #clinicaltrials #imaging #dataintegrity #drugdevelopment
To view or add a comment, sign in
-
No Brain Mets Left Behind: Autocontouring and HyperArc for High-Precision SRS With more brain metastases being detected through advanced imaging, radiotherapy teams are facing increased demands in planning and contouring time. This webinar will explore how AI-based autocontouring can support clinical teams by enhancing workflow efficiency and potentially improving treatment consistency. Join Prof. Tezcanli from Acibadem Atasehir Hospital, Istanbul, Turkey on October 29, 2025, as she shares practical insights on implementing AI-assisted solutions in the radiotherapy planning process. Key points: --Discover how autocontouring can be applied in clinical routines --Learn about potential time savings and workflow improvements --See how AI may support both single and fractionated SRS treatments https://lnkd.in/gqUVTHZA
To view or add a comment, sign in
-
-
Bunkerhill Health has received FDA clearance for Bunkerhill MAC, the first-ever AI solution to detect and quantify mitral annular calcification (MAC) on routine, non-gated chest CTs. Developed with data from 25+ leading medical centers, Bunkerhill MAC will be integrated into the Carebricks AI platform to bring actionable insights directly to clinicians. CEO, Nishith Khandwala shared: “By making MAC quantification available at scale, we’re giving clinicians a new tool to better understand risk and personalize care.” A huge step forward for #AI-powered cardiovascular care. https://lnkd.in/edwdxVJz #medicalimgaing #Radiology #Cardiology
To view or add a comment, sign in
-
"Described as the next generation of its platform, the software offers 3D, color-coded visualizations that quantify plaque blockages based on their type, volume and distribution through the vessels. According to the company, studies of its AI—which processes CT angiography scans and simulates the flow of blood—have shown it lines up 95% of the time with standard intravascular ultrasound imaging. At the same time, Heartflow said the updated algorithm has improved plaque detection 21% over its previous version. Separately, the company’s registry data have demonstrated that personalized readouts have led to changes in treatment approaches among more than half of examined patients. Heartflow said its AI has been trained on scans collected from about 273,000 people"
To view or add a comment, sign in
Explore content categories
- Career
- Productivity
- Finance
- Soft Skills & Emotional Intelligence
- Project Management
- Education
- Technology
- Leadership
- Ecommerce
- User Experience
- Recruitment & HR
- Customer Experience
- Real Estate
- Marketing
- Sales
- Retail & Merchandising
- Science
- Supply Chain Management
- Future Of Work
- Consulting
- Writing
- Economics
- Artificial Intelligence
- Employee Experience
- Workplace Trends
- Fundraising
- Networking
- Corporate Social Responsibility
- Negotiation
- Communication
- Engineering
- Hospitality & Tourism
- Business Strategy
- Change Management
- Organizational Culture
- Design
- Innovation
- Event Planning
- Training & Development