While pharmacogenomics has traditionally been the domain of academic research, policymakers are now showing a burgeoning interest in its potential to enhance patient outcomes and mounting evidence from the pharmaceutical industry is fueling interest in this field.
IDC took on the design challenge to create industry preferential surgical shears through improved ergonomics and usability. Ultrasonic shears are widely popular minimally invasive surgical instruments used for long periods in high pressure scenarios.
The consent decree restricts the production and sale of new continuous positive airway pressure (CPAP) machines, bi-level positive airway pressure (BiPAP) machines and other devices at several Philips Respironics facilities in the U.S. until certain requirements are met.
On April 17, the FDA is hosting a Virtual Public Workshop on approaches to Accreditation Scheme for Conformity Assessment Expansion.
IoT is a key factor in patient-focused digital transformation. The technology enhances precision lab equipment and operations, providing greater clarity of medical data, streamlining experimentation and fueling industrial automation.
The Investigational New Drug (IND) application and the New Drug Application (NDA) stages are critical milestones in drug development, but they are different applications. Developers and sponsors must understand which application requires which data and when. Here we highlight strategies, hurdles and data required for successful drug development from IND to NDA.
Implementing a hybrid work environment with R&D teams yields significant benefits but also presents challenges. In this article, we explore how to achieve successful R&D programs within the context of hybrid environments and share key strategies and best practices to effectively navigate the challenges, including the safeguarding of sensitive information and data.
The Rubitection skin assessment management tool for chronic wounds and Kofimi Technology’s pediatric pulse oximeter device received a combined $50,000 in grant funding as part of the ADPI-led pitch competition.
As the proliferation of wearable healthcare devices expands in terms of application and availability, they’re also becoming smaller and more powerful. In turn, testing and validation in the design phase is becoming increasingly complex.
“Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together” outlines how FDA’s medical product centers plan to address regulation of AI used in medical products and their development.
