Blood Irradiation Devices May Be Class III, FDA Panel Says
The FDA radiological devices advisory panel said that there wasn’t enough evidence backing the use of irradiation to prevent metastasis in the blood of cancer patients, especially given the treatment’s known risks.
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News We’re Watching: Biden Moves To Strengthen Supply Chain; More Medtech-Related Prosecutions; $5.5M Sepsis Grant For Siemens
This week, the Biden administration announced a new council on supply chain resilience that includes health care goals; an apparent enforcement surge against device fraud continued; Siemens won a $5.5m grant to develop a better sepsis test; and the FDA proposed new classifications for wound care products.
In this wide-ranging interview, lawyer Philip Desjardins talks about regulatory issues from AI to LDTs – as well as the passion for patient health that keeps him in the medtech arena.
The US FDA’s decision to allow Medtronic to market the Symplicity Spyral renal denervation (RDN) device sets up a rivalry in the RDN market, as the medtech giant’s offering will come up against ReCor’s Paradise system.