Dot Medical announced today that it received FDA investigational device exemption (IDE) approval for its access management ...

This creates opportunity, but it also creates risk. When a product is used in a clinical setting, even a small issue can have ...

Mass consolidation is sweeping up small medtech organizations. Med device startups and early-stage companies that want to be ...

The inventor, Ubokobong Amanam, announced the official launch and commercial distribution of the device in a Facebook post on ...

Plastics have long played a key role in enabling the design and production of numerous medical devices. But intensive work continues in design studios and materials labs around the world to advance ...

Medical device development has entered an era defined by rapid innovation, stringent regulations, and heightened expectations for quality and speed. As devices become more software-driven and ...

Ransomware attacks on the healthcare sector surged by 30 percent in 2025, frequently disrupting operational technology and medical devices. FDA Section 524B mandates that manufacturers provide a ...

IEC 62304 is widely adopted as the de facto international standard for the life cycle of medical device software (including SaMD). The key points are as follows: It defines the software life cycle ...

Hands-on research and applied technology experiences prepare University of New Haven students for careers in high-demand innovation sectors. The University of New Haven has entered into a master ...

Medical device engineering teams face a familiar paradox: innovation is accelerating, but the constraints around manufacturing, supply chain, and regulatory readiness are tightening. Devices are ...

Anyone who has worked inside a MedTech organization knows that bringing a new device to market is not a single sprint. It is a marathon made up of dozens of short, fast, sometimes messy races — market ...

Sure, you’ve heard it all before — how artificial intelligence (AI) is transforming design and development and the production process across the board, and that companies that don’t embrace the ...