Machina Medical, Corp. today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for ...

In 2025, the U.S. Food and Drug Administration (FDA or the Agency) issued a surprising number of enforcement letters to ...

Executives and investors in Thousand Oaks-based immunotherapy company Atara Biotherapeutics Inc. were left reeling last week ...

The FDA believes that data on MRD and complete response can expedite new drug delivery compared with long-term survival ...

The FDA approved external trigeminal nerve stimulation (TNS) in 2019 as the first non-drug device for treating ADHD, ...

Drew & Jonathan call out a design trend they believe seriously needs to go.

Recently, the U.S. Food and Drug Administration (FDA) issued a guidance document entitled Use of Real-World Evidence to Support ...

BDX wins FDA 510(k) clearance for the EnCor EnCompass breast biopsy system, set for an early 2026 launch to boost flexibility and patient care.

"We are grateful for the collaborative feedback from FDA on the Gemini program, which provides us a clear and expedient path forward for seeking approval of Gemini as a treatment for AKI," said, James ...

Industry consultant Michael Drues will discuss how medical device companies can better prepare for FDA inspections.

In A Nutshell • A brain stimulation device cleared by the FDA in 2019 failed to beat placebo in a rigorous 150-participant ...

Shares of ImmunityBio IBRX surged 17.4% after it announced a recent face-to-face meeting with senior FDA officials to align ...