The International Electrotechnical Commission (IEC) and the International Organization for Standards (ISO) recently published a cybersecurity standard that has received limited press but may have a ...

The world of medical devices is rapidly changing. In place of disconnected, simple medical devices, a new world of complex software both on and off the now-connected device is providing a larger ...

Discover how software developers for medical-device OEMs are balancing innovation and safety, and the challenges they face in making it happen. The medical-device industry is rapidly advancing, from ...

Tech Exactly is a software development company specializing in HIPAA-compliant healthcare applications, AI-powered solutions, and fintech platforms. Founded by Hitesh Agarwal, the company partners ...

The FDA recalled 60 medical devices last year, and the running total for this year is 56. The good news is that there’s a startup working to make future totals lower. The startup, named Ketryx, ...

Software in the healthcare industry has come a long way over the past 20 years. Medical device companies, like most life sciences companies, were a bit hesitant to incorporate software and automation ...

The European Union has released two significant guideline changes to expand its medical device framework, updating the classification rules for medical device software to include app platform ...

There has been a surge in academic and business interest in software as a medical device (SaMD). It enables medical professionals to streamline existing medical practices and make innovative medical ...

Medical software is the backbone of modern healthcare, supporting electronic health records (EHRs), diagnostic systems, imaging technologies and embedded software in medical devices like pacemakers ...

Dublin, April 15, 2026 (GLOBE NEWSWIRE)-- The "Medical Device Software: Complying with the EU MDR, EU IVDR & FDA Regulations (June 22nd - June 26th, 2026)" training has been added to ...

On June 7, 2024, the Court of Appeals for the DC Circuit in Medical Imaging & Technology Alliance et al. v. Library of Congress et al., No. 23-5067 (D.C. Cir.), vacated an earlier district court ...