CMS’s proposed expansion of Medicare TAVR coverage to include select asymptomatic severe aortic stenosis patients and reduce access barriers for symptomatic patients could significantly increase TAVR adoption, creating a growth opportunity for Edwards Lifesciences through expanded eligibility, higher procedure volumes, and continued leadership in structural heart care.
Why is algorithmic transparency becoming an increasingly important consideration in FDA’s review of AI/ML medical devices?
FDA Commissioner Marty Makary says, one-day inspections can strengthen our inspectional approach by focusing our time and resources where they are most needed—enhancing our overall effectiveness.
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.
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.
New pathway cuts red tape and brings predictability to Medicare coverage for Breakthrough Devices.
Allevion Medical Receives FDA Clearance for Vantage™, Introducing a Fully Disposable Approach to Minimally Invasive Spinal Decompression.
New technology designed to provide a single irrigation management system for ureteroscopy, cystoscopy, percutaneous nephrolithotomy (PCNL) and benign prostatic hyperplasia (BPH) procedures.
New set of 73 Real World Evidence examples illustrate how RWD can support rigorous validation of novel device software functions across multiple disease areas.
EUDAMED is mandatory at the end of May and many manufacturers aren’t ready.
