Tag: fitness trackers

The United States Food and Drug Administration (FDA) has granted 510(k) clearance to Neptune Medical’s Triton robotic system, marking a significant milestone in the evolution of gastrointestinal (GI) diagnostics and therapeutic intervention. This regulatory approval clears the path for the commercial introduction of a technology designed to provide gastroenterologists with unprecedented control over endoscopes during…

The healthcare industry is currently undergoing a rapid technological pivot as organizations move beyond static artificial intelligence models toward "agentic AI"—systems capable of autonomous decision-making and executing complex, multi-step workflows with minimal human oversight. While this transition promises to revolutionize clinical efficiency and administrative accuracy, a new report from identity security firm Imprivata reveals a…

The U.S. Food and Drug Administration (FDA) has awarded a $1.29 million research contract to Cognita Imaging, a move intended to revolutionize the way generative artificial intelligence is validated and regulated in the medical imaging sector. This 18-month initiative, which officially commenced on June 22, focuses on developing a scalable methodology for evaluating AI-generated radiology…

In a strategic move designed to streamline leadership and accelerate international growth, Dexcom Inc. has officially appointed Jereme Sylvain as its new Chief Operating Officer. Sylvain, who has served as the company’s Chief Financial Officer since 2021, will retain his responsibilities as the head of finance while taking on this expanded operational mandate. The appointment,…

Medtronic, a global leader in medical technology, has officially announced that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its LigaSure RAS Maryland instrument designed for use with the Hugo robotic-assisted surgery (RAS) system. This regulatory milestone marks a significant expansion of Medtronic’s surgical robotics portfolio in the United States,…

In a strategic move aimed at refining its medical technology holdings, Johnson & Johnson has finalized the divestiture of its Laminar left atrial appendage (LAA) closure business to Jaguar LAA, a newly formed entity established in partnership with the investment firm Santé Ventures and members of the original Laminar management team. The transaction represents a…

Medtronic, a global leader in medical technology, has officially announced the appointment of Lara Barghout as the new President of its Interventional Cardiology Therapies (ICT) business. Barghout, a seasoned executive with over two decades of experience in the medtech sector, joins the company following a high-profile tenure as the CEO of Recor Medical. Her transition…

The Centers for Medicare and Medicaid Services (CMS) has announced a significant expansion of its flagship digital health initiative, the Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) model. Just two months after its initial launch, the federal agency is broadening the program’s scope to include several of the most prevalent and costly chronic conditions…

The medical technology landscape in Europe has reached a new milestone in robotic-assisted surgery with Intuitive Surgical’s announcement that its da Vinci SP (Single Port) system has received CE mark clearance for transvaginal gynecologic procedures. This regulatory authorization significantly broadens the clinical scope of the single-port platform, allowing surgeons to utilize the system for a…

The Department of Health and Human Services (HHS) Office of Inspector General (OIG) has issued a comprehensive report highlighting critical vulnerabilities within the Medicare Advantage (MA) program, specifically regarding the oversight and screening of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) providers. According to the federal watchdog, the Centers for Medicare & Medicaid Services…