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President Biden’s fiscal 2023 budget request for the FDA calls for an increase of almost 10 percent in funding for regulation of medical devices. Read More
The European Commission’s Medical Device Coordination Group (MDCG) has released new guidance on compliance of high-risk devices such as pacemakers and prosthetic heart valves with the EU’s Medical Device Regulation (MDR). Read More
“In addition to reducing existing acne, clinical trials show that future breakout episodes are shorter, less intense, and more infrequent following the AviClear procedure,” the company says. Read More
The FDA has issued an 8-observation Form 483 to Hampton Medical Devices, based on an inspection last November of the company’s manufacturing facility in Festus, Mo. Read More
Roche and Bristol Myers Squibb (BMS) are teaming up to use artificial intelligence (AI) to support the use of two assays in clinical trials for tumor treatment. Read More