Device Makers are currently at an intersection of accelerated innovation and heightened regulatory scrutiny. Regulatory affairs stands in the center guiding operational resilience and a coherent ...

Artificial intelligence is moving quickly into mainstream medical devices, and the industry has become fluent in a familiar set of concerns: bias, transparency, and cybersecurity. These topics matter, ...

The next phase of digital mental health adoption depends less on innovation and more on how the industry uses real-world evidence, builds reimbursement frameworks, and applies regulatory precedent to ...

In the current Cyber Threat environment, companies must have strong cyber liability insurance. Policies must specifically account for cyber-physical risks and the substantial costs of post-market ...

While off-label use may be permissible, contraindicated use still has a strong regulatory boundary as reinforced by FDA guidance finalized in 2025. Medical devices are routinely used in clinical ...

omico’s new facility expands its global production capacity and enhances its ability to be close to customers without taking on excessive risk. A reliable source of labor, a location that could ...

How is software-enablement — connected devices and artificial intelligence — reshaping how products are conceived, developed, and deployed in clinical practice? Fragmented operations in large MedTech ...

Whether gluing or molding, designers must carefully address each challenge to ensure reliable, consistent, and accurate manufacturing – and to avoid costly redesigns or patient safety risks later.

Trial will evaluate the safety and effectiveness of the AtriCure Isolator® Synergy™ EnCompass® clamp and AtriClip® Left Atrial Appendage Exclusion System to reduce the occurrence of new-onset atrial ...

WALTHAM, Mass.–(BUSINESS WIRE)– Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, today announced a definitive agreement to acquire Clario Holdings, Inc., a leading ...

Boston Scientific has been a strategic investor in Nalu Medical since 2017. The transaction consists of an upfront cash payment of approximately $533 million for the remaining equity not owned by ...