From 2015 through 2018, about 20% of 510(k) clearances were based on substantial equivalence to a predicate device that was more than a decade old. Should FDA continue to allow this practice, or should older devices be retired as predicates?
Right now we’re in the middle of the Artificial Intelligence Renaissance for medtech. But what does this mean for companies? Is this a fad or is AI here to stay in medtech. MD+DI Managing Editor Omar Ford gives his thoughts on this emerging trend.
Doctors need more tools to quickly determine whether an antibiotic is truly needed, an expert tells MD+DI.
One year into the transition periods for the new EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), industry experts continue to express concern that more progress is needed to help companies prepare for the new regulations within the limited transition period.
Using VR during usability testing enables real-time design iteration in response to user feedback without the need to travel.
A presentation at the upcoming BIOMEDevice San Jose show will cover issues in connectivity for this growing segment of the medical device industry.
Medical professionals across the country are standing up to the National Rifle Association after the organization told doctors to "stay in their lane." Will medtech take a stand on the issue?
Establish a supportive vendor relationship by providing exceptional training during device installations.
Respondents to a recent survey on the new EU regulation raise some concerns about readiness. Are you prepared?
Intuitive Surgical has been dominant in surgical robotics for years now, but Medtronic and Verb both have systems that are on the horizon and will be in direct competition with the da Vinci, said Roger Smith, who follows the space closely.