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News

Medical Product Outsourcing
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FDA Expands AI Capabilities and Completes Data Platform Consolidation

1+ day, 11+ hour ago   (182+ words) Agency is building its Elsa platform to be the main entrée into its systems and data. The U.S. Food and Drug Administration (FDA) is taking a major step to modernize the agency with Elsa 4.0, a significant upgrade to its…...

Medical Product Outsourcing
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Steve Deitsch Joins Endologix's Board of Directors

1+ day, 11+ hour ago   (303+ words) New member currently is CEO of Caristo Diagnostics. Endologix LLC has appointed Steve Deitsch to its Board of Directors. “Having worked closely with Steve while on the OrganOx board, I’ve seen firsthand his strategic insight, financial acumen, and ability to…...

Medical Product Outsourcing
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Dr. Steven Steinhubl Joins Eko Health as Chief Medical Officer

1+ day, 11+ hour ago   (184+ words) New hire will help advance clinical innovation and global impact of AI-enabled cardiac detection. Eko Health has appointed Steven R. Steinhubl, M.D., as chief medical officer (CMO) and member of the executive leadership team. “Steve understands both the clinical realities of cardiovascular…...

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Lucent Diagnostics, Tempus Collaborate on Blood-Based Alzheimer’s Biomarker Testing

1+ day, 12+ hour ago   (147+ words) The agreement supports the identification of patients eligible for Alzheimer’s disease biomarker testing through Tempus Next. Lucent Diagnostics, a brand of Quanterix Corporation, is partnering with Tempus AI Inc. to expand access to a blood-based biomarker panel aimed at improving…...

Medical Product Outsourcing
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Magnendo Banks $18M for Neurovascular Robotics

1+ day, 13+ hour ago   (165+ words) The Series A funding round was led by Penumbra and funds will be used to advance its robotic neurovascular navigation platform. Magnendo Corp., an MIT spinout developing magnetic robotic navigation technology for neuroendovascular procedures, has raised $18 million in a Series…...

Medical Product Outsourcing
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Former Medtronic, Zimmer Biomet Executive to Lead Turbett Surgical

1+ day, 12+ hour ago   (618+ words) Managing Editor Michael P. Barbella has worked as a journalist for nearly 25 years, reporting for newspapers, television and trade magazines. He began his career chronicling North Jersey politics, education, business and lifestyle for two daily newspapers before lending his skills to…...

Medical Product Outsourcing
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VisualDx and Perplexity Collaborate on AI-Powered Medical Imaging

2+ day, 10+ hour ago   (169+ words) New partnership improves AI health answers with visual intelligence grounded in real clinical practice. “Medicine is visual,” VisualDx Co-Founder/CEO Art Papier, M.D., said. “So much of a diagnosis depends on pattern recognition and comparison. By integrating VisualDx into…...

Medical Product Outsourcing
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Study Data Show Short-Term Holter Monitoring Misses AF Recurrence Post-Ablation in Pregnancy

2+ day, 11+ hour ago   (644+ words) The findings highlight the importance of arrhythmia detection in pregnancy. Real-world study data support a shift away from short-duration Holter monitoring toward up to 14 days of continuous, uninterrupted monitoring with iRhythm Holdings Inc.’s Zio ambulatory ECG devices to reduce…...

Medical Product Outsourcing
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Dexcom Kicks Off FDA's TEMPO Digital Health Device Pilot

2+ day, 14+ hour ago   (277+ words) Dexcom will implement an AI-powered glucose health program that merges CGM data with info about nutrition, physical activity, sleep, and stress. Dexcom announced that it was the first company selected to participate in the U.S. Food and Drug Administration’s (FDA) Technology-Enabled…...

Medical Product Outsourcing
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Karl Storz Teams Up with Moon Surgical, Sovato to Advance Digital Surgery

2+ day, 12+ hour ago   (230+ words) Karl Storz has begun collaborating with Moon Surgical and Sovato to bring together advanced 3D visualization, robotic technologies, digital capabilities, and operating room integration. The German medtech company hopes to create a more open, connected approach to OR surgical innovation, which…...