Medtech groups call for extended commentary and compliance periods for two new EtO regulations from the EPA.
Medical device manufacturers need more time.
Industry leaders came together on 2-3 May to provide feedback to the US Environmental Protecion Agency during public hearings on...
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The US Department of Commerce’s investigation into the national security impact of importing various medical equipment could lead to tariffs on many products. Device industry responds by emphasizing the robustness of domestic production, but also the rigidity of supply and reimbursement agreements.
Banking on new billing codes for remote services, PAVmed’s Veris Health is expanding its oncology remote monitoring platform with Ohio State’s cancer center and developing an implantable physiological monitor to provide clinicians with continuous insights between treatment visits.
Some of the first manufacturers to receive Medicare coverage for their breakthrough devices through the Transitional Coverage for Emerging Technologies pathway praise CMS’ engagement and timelines in the process, despite some challenges around post-launch data collection.
Excitement surrounds Multi Cancer Early Detection testing for diagnosing hard-to-detect cancers early and improving patient outcomes. But without full randomized trials – only accuracy studies – physicians lack enough evidence to use them confidently, said physician and researcher Daniel Jonas.
During a town hall session at AdvaMed’s MedTech Conference in San Diego, US FDA device center head Michelle Tarver discussed the center’s successes in product approvals, digital health, home healthcare and more amid a tumultuous year.
Ceribell has filed patent-infringement claims against Natus alleging its BrainWatch EEG copies Ceribell’s headband and electrode innovations. Natus denies any intellectual property violations, saying the products serve different purposes.
At AdvaMed’s MedTech Conference in San Diego, speakers brainstorm ways to bring devices to treat children to market more quickly through creative collaboration, better use of real-world data, and taking advantage of ‘low-hanging fruit’ like expanded size ranges.
