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The FDA announced the nine participants selected for its first digital health software pre-certification pilot program, ranging from startups to giants in the space. Read More
3D printing is poised to transform the medical device industry, according to several players in the space who participated in a recent FDAnews webinar. Read More
The voluntary Medical Device Development Tools program is intended to facilitate finding measuring tools to help streamline regulatory reviews. Read More
The potential benefits of MPOCTs include improved patient health care and management, more appropriate use of antibiotics, limiting the spread of disease and cost savings. Read More
Government Accountability Office researchers visited eight devicemakers in connection with a new report on diagnostic medical devices and found that the regulatory review process poses an obstacle to applying the technology in the marketplace. Read More
Early human-factor studies can address many questions on usability before combination products enter clinical testing, according to John Towns, a senior research fellow at Eli Lilly & Co. Read More
Developers of medical devices designed to preserve organs for transplant should carefully evaluate the risk of injury to the organs as they test the devices with animal subjects, whether they measure outcomes in vivo or ex vivo, the FDA says in new draft guidance. Read More