The FDA designated 166 products under its breakthrough devices program in its most recent financial year, reversing the ...

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 ...

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 ...

The technology is integrated with company’s electroanatomical mapping system, which helps guide operators during AF ablation.

The new director at the FDA overseeing medical devices will confront criticisms about hasty approvals as she ushers in ...

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 ...

A primary benefit of the FDA Fast Track designation is how it accelerates the drug approval process. Early and continuous ...

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 ...

A wearable technology is the latest addition to the treatment mix. The FDA has approved a Novocure medical device that uses fields of electricity to kill cancer cells. The regulatory decision anno ...

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 ...