If Your AI Can’t Explain Itself, Can FDA Authorize It?
Why is algorithmic transparency becoming an increasingly important consideration in FDA’s review of AI/ML medical devices?
Tag Archives: FDA
FDA Expands AI Capabilities: Launches ELSA and Completes HALO Data Platform Consolidation
The agency launched Elsa 4.0, an upgrade to the agency’s internal AI tool available to all FDA staff, from scientific reviewers to investigators.
Trump Planning to Fire FDA Commissioner Marty Makary
Top administration officials have become increasingly convinced Makary has to go because, in addition to months of turmoil, complaints from some in the pharmaceutical industry have continued to mount, people familiar with the matter said.
CMS, FDA Announce RAPID Coverage Pathway to Accelerate Device Reimbursement
New pathway cuts red tape and brings predictability to Medicare coverage for Breakthrough Devices.
Beyond Reporting: Realizing Continuous Safety Surveillance for Medical Devices
Having already set expectations around the structured capture of medical device safety data, regulators are now ready to analyze related insights, and they expect device manufacturers to match this capability.
Endospan Receives FDA Approval for the NEXUS Aortic Arch Stent Graft System
The FDA has approved the NEXUS Aortic Arch Stent Graft enabling commercial launch of the NEXUS System in the US.
InVera Medical Receives FDA Clearance for Non-Thermal Chronic Venous Disease Device
The InVera Infusion Device is approved for use in the US and EU within its indications.
FDA Publishes New Set of Real-World Evidence Examples
New set of 73 Real World Evidence examples illustrate how RWD can support rigorous validation of novel device software functions across multiple disease areas.
CDRH Guidance: Patient Preference Information (PPI) in Medical Device Decision Making
Patient Preference Information (PPI) guidance on when and what methods to use to collect and submit patient preference information (PPI) for a device to FDA.
LivaNova Receives FDA Premarket Approval for to treat Moderate to Severe Obstructive Sleep Apnea
Hypoglossal nerve stimulation therapy approved in the U.S. without complete concentric collapse contraindication or warning language. The next-generation, MRI-compatible device is expected to launch in the first half of 2027, pending FDA supplement review.