Visit Medbio at DeviceTalks Boston 2026 to explore scalable manufacturing solutions supporting next-generation robot-assisted surgical systems, precision molding, automation, assembly, and ...

Across industries, innovation platforms constantly monitor device usage and anticipate future needs, fueling breakthrough ideas in real time. AI agents are dissolving silos in large organizations, ...

Safety, ease of use, and accuracy guide modern medical device design, advancing through improved materials, engineering ...

The digital revolution that resulted in the Internet of Things (IoT), Internet of Medical Things (IoMT), Software as a Medical Device (SaMD), and connected devices permeating the healthcare ...

Artificial intelligence (AI) and machine learning (ML) are redefining healthcare, from enabling earlier diagnoses and personalized treatments to streamlining hospital operations and accelerating ...

Periodically, standards are revisited by international and national committees to determine if they are still current or need revision or withdrawal. Through the voting process and based on comments ...

AI-assisted symptom recognition and pattern matching leverages machine learning to analyze vast amounts of medical data, including patient histories, clinical notes, and research publications, to ...

SCS devices deliver electrical pulses to the spinal cord to relieve chronic pain. They are often used as treatment for failed back surgery syndrome, injuries to the spinal cord, complex regional pain ...

At the end of 2019, the Digital Healthcare Act (Digitales Versorgungsgesetz, DVG) introduced a dedicated pathway enabling reimbursement of digital health offerings in Germany, bringing more ...

An FDA warning letter is more than a formal notice; it’s a visible sign that a company’s quality system has failed to meet critical expectations. Yet behind every warning letter lies a wealth of ...

The FDA proposed on Feb. 22, 2022, an update to the Quality System Regulation 1 that was released in 1996. The proposal is to reference ISO 13485:2016 Medical devices — Quality management systems — ...