Many medical device companies develop software using a traditional waterfall methodology in which each step is taken in sequence: requirements, design, implementation, verification, and validation ...

Medtech developers incorporating AI or machine learning into medical devices need to recognize if and how FDA will regulate ...

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 ...

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 ...

Software-based medical devices are integral to healthcare. To enter the marketplace, a company must successfully navigate and comply with applicable national and international regulatory requirements.

FDA revised guidance documents for low-risk wellness products and clinical decision software, clarifying regulatory ...

The Transparency Principles emphasize the effective communication of relevant information about a MLMD to users, such as the intended use(s), device development, device performance, and method for ...

Tata Elxsi, a global leader in design and technology services, today announced the launch of AnaTel™, an AI-native software development platform for healthcare and medical technology companies, ...

The latest update to the Federal Drug Administration (FDA) for medical device cybersecurity mandates the development of a software bill of materials (SBOM). This provision can be a significant ...

Hacking pacemakers and insulin pumps is mostly hype; thankfully the scary stories are just that, scary possibilities that could supposedly happen if attackers were to target vulnerable devices. Some ...

Butterfly Network, Inc. (NYSE: BFLY) ("Butterfly"), today announced that it will participate in the TD Cowen Medical Devices Emerging Growth Call Series at 12:00pm ET on June 18, 2026. Joseph DeVivo, ...