Health Canada Issues Final Guidance on 3D-Printed Implantable Devices
Health Canada issued final guidance for devicemakers on supporting evidence required for submitting applications for 3D-printed implantable devices. Read More
Senator Demands Answers From Companies Over Duodenoscopes
Washington Democratic Sen. Patty Murray is demanding answers from the leaders of three device companies at the center of an ongoing FDA investigation of… Read More
Devices News
CMS Proposes to Boost Payments for Breakthrough Devices
The Centers for Medicare and Medicaid Services proposed a new rule that would increase payments for breakthrough medical devices. Read More
FDA Issues Final Guidance on Bench Performance Testing
The FDA issued final guidance recommending what information devicemakers should include in test report summaries, test protocols and complete test reports for non-clinical bench performance testing for their premarket submissions. Read More
FDA Wants Sponsors to Flag Real-World Evidence
The FDA may start accepting real-world evidence in support of device applications, but sponsors need to identify the sources of real-world evidence they’re using in advance, the agency said. Read More
Surgisil Warned for Unapproved Marketing of Facial Implant
Plano, Texas devicemaker Surgisil is in hot water with the FDA over its Perma Facial Implant, a device that is only cleared for cosmetic facial augmentation and augmentations in areas like the nose, chin and cheeks. Read More
