Optune Lua is FDA approved for use with immunotherapy or docetaxel in metastatic stage IV NSCLC post-platinum treatment. The device uses tumor treating fields to disrupt cancer cell division ...

Novocure received a long-sought FDA approval for the use of its Tumor Treating ... Its portable Optune Lua device, with arrays on adhesive patches worn on the chest or back, received a green ...

The FDA has approved Traumagel, a device that can stop bleeding from gunshot wounds in seconds, potentially saving countless ...

Most notably, 226 of 521 FDA-approved medical devices, or approximately 43%, lacked published clinical validation data. A few ...

The Food and Drug Administration on Tuesday approved a new device to treat non-small cell lung cancer, Novocure’s Optune Lua, which creates electric fields that its manufacturer says disrupts ...

The FDA has approved a digital device developed by Cognoa that can be used to diagnose autism spectrum disorder (ASD), just a few weeks after it was filed for approval.

We need more science in the FDA approval process.” Spotlighting the issue is a new study in the Annals of Internal Medicine looking at recalls of heart devices -- like pacemakers, stents ...

This is detected and determined by an FDA-approved test after patients have experienced recurrence on or after the completion of adjuvant endocrine therapy. The agency also announced that it has ...

WHITE BEAR LAKE, Minnesota, Nov. 01, 2024 (GLOBE NEWSWIRE) -- Envoy Medical®, Inc. (“Envoy Medical”) (NASDAQ: “COCH”), a hearing health company focused on fully implanted hearing systems ...

“Receiving FDA approval to initiate this pivotal study marks a significant milestone in our efforts to bring this breakthrough hearing device to more people with severe to profound hearing loss ...