Animal and bench testing is generally not adequate to support 510(k) clearance of coronary and carotid embolic protection devices, FDA says in a guidance document released Feb. 15. Clinical trials for the devices, which act as filters to capture and remove debris loosened during angioplasty or stenting, should be randomized unless an appropriate historical control can be identified for a single-arm study, the agency notes. Carotid embolic protection devices can generally be studied in conjunction with investigational carotid stent systems. FDA recommends a primary trial endpoint of all major adverse cardiac events, plus cerebrovascular events for carotid systems, at 30 days post procedure. An editorial in the Feb. 12 issue of Circulation from CDRH staffers suggests that single-arm studies for coronary embolic protection devices, used during intervention in diseased saphenous vein grafts, could be facilitated by further collaboration between industry, academia and regulators to develop benchmarks using data from previous trials
Join thousands of industry professionals who rely on Medtech Insight for daily insights
Already a subscriber?
Editor’s note: This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.
Editor’s note: We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, content format or the method in which you receive and access Medtech Insight, or if you love it how it is, now is the time to have your voice heard.
Medtronic announced it received expanded MRI labeling for its DBS systems, which is critical, given that almost 70% of all DBS-eligible patients will likely need an MRI at some point in their care, says Ashwini Sharan, CMO for Medtronic Neuromodulation.
In this episode, Medtech Insight reporter Natasha Barrow speaks to LungLife AI CEO Paul Pagano. Lung Life AI is a US-based AIM-listed medical technology company that has developed a liquid biopsy test for the early detection of lung cancer called Lung LB. Pagano runs through the highlights of Lung Life AI journey to date and its future ambition for a strategic partnership. He also provides advice to similar diagnostic companies seeking reimbursement andcompliance with the US FDA Lab Developed Test ruling.
Eko hopes its new partnership with Boehringer Ingelheim to develop algorithms for accurately detecting heart murmurs in dogs will pave the way for more collaborations with medical and pharmaceutical companies to advance early detection in humans as well as animals.
Experts at the Prix Galien UK Forum discussed the future of mental health innovation, emphasizing the important roles of digital solutions, diagnostic biomarkers and community involvement.
With new regulations limiting the use of plastics popping up worldwide, the medtech industry sees arguments on both sides. Some argue hasty bans of PFAS ("forever chemicals") would harm patients, while others say phthalates should be phased out to protect the public.
