medical device
Jun 11, 2025
AI Healthcare Startups: Unveiling Investment and Funding Trends
Buckle up, because the world of AI healthcare startups is on fire! Investors are throwing serious cash, think billions, at companies using artificial intelligence to shake up the pharmaceutical industry. Over the past decade, a jaw-dropping USD 60 billion has flooded into AI healthcare startups, with USD 30 billion...
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Jun 05, 2025
Guardant Health’s Shield Test Earns FDA Breakthrough Device Status; Reflow Medical Gains FDA De Novo Clearance for Spur Peripheral Stent System; FastWave Medical Achieves First-in-Human Use of Coronary Laser IVL System; BD Initiates Patient Registry to Assess Rotarex™ System in PAD Treatment; Johnson & Johnson Unveiled the KINCISE™ 2 System for Use in Knee and Hip Revision Surgeries; Cardinal Health Launches Single-Device Solution for Real-Time Tracking of Three Vital Signs
Guardant Health Secured FDA Breakthrough Device Designation for Its Shield Multi-Cancer Detection Test On June 03, 2025, Guardant Health, Inc., a precision oncology company, reported that the U.S. Food and Drug Administration (FDA) granted breakthrough device designation to its Shield multi-cancer detectio...
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May 29, 2025
Olympus Gains FDA Clearance for EDOF™ Imaging Endoscopes; FDA Approves Abbott’s Tendyne™ Device for Minimally Invasive Mitral Valve Replacement; New Study Validates Exact Sciences’ Oncodetect™ for Enhanced MRD Detection in Stage II-IV Colorectal Cancer; Sensome Completes First-in-Human Trial Enrollment for Lung Cancer Detection System; J&J MedTech Introduces SOUNDSTAR CRYSTAL™ to US Market with Breakthrough 2D Imaging Quality; Terumo Launches ROADSAVER™ Carotid Stent System to Improve Outcomes in Carotid Artery Stenosis
Olympus Secured FDA Clearance for Cutting-Edge EDOF™ Imaging Endoscopes, Redefining Visibility with Sharper, Blur-Free Views On May 27, 2025, Olympus Corporation, a global leader in medical technology and endoscopic imaging, announced that it received FDA 510(k) clearance for its next-generation EZ1500 series en...
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May 22, 2025
FDA Clears Fujirebio’s Lumipulse® G Plasma Test for Detecting Alzheimer’s-Linked Amyloid Pathology; Stryker Gains FDA Clearance for OptaBlate® BVN System to Treat Chronic Low Back Pain; Abbott Unveils Clinical Evidence Linking Libre® CGM to Reduced Cardiovascular Events in Diabetes; GE HealthCare Launches AI-Based CleaRecon DL for Enhanced 3D Reconstruction in Interventional Suites; Philips Advances Cardiac Care with Launch of RADIQAL Clinical Study and Real-Time 3D Intracardiac Imaging Catheter in Europe
Fujirebio Received FDA Clearance for Innovative Lumipulse® G Plasma Biomarker Test, Marking Major Advancement in Identifying Amyloid Pathology Linked to Alzheimer’s Disease On May 16, 2025, Fujirebio announced that the U.S. Food and Drug Administration (FDA) granted 510(k) clearance for its Lumipulse® G pT...
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May 15, 2025
Glucotrack Secures Ethical Approval for Extended Clinical Trial of Continuous Blood Glucose Monitor; GE HealthCare Announces FDA Approval for Pediatric Use of Optison and Launches New Ultra-premium 1.5T MRI System; Envoy Medical Advances to Final Stage Following Clinical Milestone; SeaStar Medical Hits Interim Enrollment Goal in NEUTRALIZE-AKI Trial; BD Unveils New Cell Analyzer Integrating Spectral and Real-Time Imaging Innovations
Glucotrack Announced Ethical Approval for Long-Term Clinical Study of Continuous Blood Glucose Monitor On May 13, 2025, Glucotrack, Inc., a medical device company focused on the design, development, and commercialization of novel technologies for people with diabetes, announced that it received ethical app...
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May 14, 2025
Generative AI in Drug Discovery: Applications and Market Impact
The pharmaceutical industry stands at a crossroads, where innovation is no longer a luxury but a necessity. The AI in the drug discovery market is at the forefront of this transformation, driven by the remarkable capabilities of generative AI. This technology, which creates novel solutions by learning from vast dat...
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May 08, 2025
Teleflex Receives FDA 510(k) Clearance to Expand Use of QuikClot Control+™; Edwards Wins FDA Nod for TAVR Use in Asymptomatic Aortic Stenosis; LivaNova Announces Positive 12-Month Results from OSPREY Study in Moderate to Severe OSA; Lipogems Completes Final Patient Visit in ARISE 1 Knee Osteoarthritis Trial; Roche Launches Advanced Elecsys PRO-C3 Test for More Accurate Liver Fibrosis Grading; iRhythm Introduces Zio® Long-Term ECG Monitoring in Japan, Enhancing AI-Driven Arrhythmia Detection
Teleflex Secures FDA 510(k) Clearance for Broader Use of QuikClot Control+™ Hemostatic Device On April 30, 2025, Teleflex Incorporated, a global leader in medical technologies, announced that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the expanded Indications for Use ...
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May 07, 2025
Artificial Intelligence and Machine Learning in Software as a Medical Device (SaMD)
Artificial Intelligence (AI) and Machine Learning (ML) are reshaping the world of Software as a Medical Device (SaMD), bringing a new level of intelligence and efficiency to healthcare. SaMD refers to software designed for medical purposes that doesn’t rely on physical hardware. When integrated with AI/ML, these so...
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May 01, 2025
Medtronic Receives FDA Approval for OmniaSecure™ Lumenless Defibrillation Lead and Presents Positive Clinical Trial Results for Hugo™ Robotic-Assisted Surgery System; Roche’s AI Companion Diagnostic for NSCLC Earns FDA Breakthrough Device Designation; Boston Scientific Announces Positive 12-Month Phase 2 Results from ADVANTAGE AF Trial of FARAPULSE™ PFA System; Bausch Health Launches Fraxel FTX™ to Advance Skin Rejuvenation Treatments; Gestalt Diagnostics Secures $7.5M in Series A to Scale AI Pathology Solutions
Medtronic Received FDA Approval for Smallest-Diameter, Lumenless Defibrillation Lead, the Omniasecure™ Lead and Published Investigational Clinical Study Results, Offering New Therapy Option for Heart Rhythm Disorders On April 25, 2025, Medtronic plc., a global leader in healthcare technology, received U.S....
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Apr 30, 2025
Navigating U.S. Tariffs in 2025: Impacts and Strategies for Pharma and Healthcare
In 2025, the United States launched a bold new wave of tariffs, targeting imports critical to the pharmaceutical and healthcare industries. These policies, driven by a push to strengthen domestic manufacturing, impose a 10% tariff on all imported goods, alongside steeper levies of up to 245% on Chinese active pharm...
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