Device makers doing business in the U.S. have had a much more stable regulatory regime than has been true for companies in other jurisdictions, but that will shift somewhat in 2025. Brynn Stanley of ...

In a significant step toward ensuring global quality standards, Indian pharmaceutical, nutraceutical, and medical device ...

The FDA has issued a warning letter related to BD Pyxis automated medication dispensing systems — technology that was part of ...

The contents of the NEJM Catalyst–J-Med supplemental issue on care delivery in China capture the transformative strides in China’s health care system.

BD received a warning letter after the Food and Drug Administration found fault with the practices at a facility that manufactures Pyxis medication management system medical ... that listed issues ...

The FDA found Carefusion was noncompliant with the decree after inspecting a site in San Diego in 2020. An inspection in May generated a Form 483 that listed issues related to quality system and ...

BOSTON, MA / ZURICH, SWITZERLAND / ACCESSWIRE / December 20, 2024 / The Swiss MedTech startup ZuriMED Technologies AG is pleased to announce FDA clearance of its FiberLocker® System, a cutting-edge ...

The Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for TNX-102 SL (cyclobenzaprine HCL sublingual tablets) for the management ... in sleep quality, fatigue, and ...

Zurich (Switzerland), December 20, 2024 – The Swiss MedTech startup ZuriMED Technologies AG is pleased to announce FDA clearance of its FiberLocker® System, a cutting-edge ... which are improving ...

Inc., the creator of the innovative WiSE® CRT System for heart failure, has scheduled a crucial Pre-Approval Inspection with the FDA for early January 2025. This milestone is part of the ongoing ...

For every illegal drug, there is a combination of emojis that ... through online networks are subject to “potentially better quality control”—with Telegram channels devoted to discussing ...