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 ...

"Being able to induce a broad range of specific cardiac disease such as HFpEF, which remains one of the least well understood and hardest heart failure conditions to treat, we hope to aid in the ...

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 ...

Learn how to select TPU materials for catheters, tubing & implantable devices based on chemistry & performance from material ...

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 ...