As the world’s medical device regulators work to harmonize how best to regulate software as a medical device (SaMD), MobiHealthNews has learned via a Freedom of Information Act request that the FDA ...
The FDA has entered into the federal register a new draft guidance pertaining to "software as a medical device" (SaMD). The guidance is presented as representing the FDA's current thinking on ...
Explore FDA's QMSR and cybersecurity mandates for medical devices, including SPDF, SBOMs, and legacy medical device ...
Following eyonis® LCS' FDA 510 (k) clearance announced on February 9, 2026, Median has activated a phased U.S. launch strategy designed for disciplined national expansion. The Company has conducted ...
Medical Device Network on MSN
FDA clears Median Technologies’ lung nodule evaluation software
Median's eyonis LCS is software is reimbursable under Medicare at a rate between $601 to $700.
The Food and Drug Administration has finalized a regulation that provides a less-burdensome path to market for certain hardware and software products used with medical devices, according to an FDA ...
The healthcare industry faces an unprecedented cybersecurity crisis as connected medical devices proliferate at an alarming ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results