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MichClone Associates, a medical device manufacturer in Troy, Mich., has received a seven-observation Form 483 from the FDA for deficiencies observed during an inspection late last year. Read More
Synchron’s Stentrode investigational brain-computer interface device has been found safe and effective in a small study of patients with paralysis caused by amyotrophic lateral sclerosis (ALS). Read More
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
The FDA expects devicemakers to follow Quality Systems Regulation-compliant procedures for installing equipment used in the course of device manufacture, including any ancillary equipment that affects production, such as environmental systems and contamination controls. 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
The Advanced Medical Technology Association (AdvaMed) is leading the device industry in asking the FDA to go slow on its transition from pandemic-era authorization approaches to more normal operating status. Read More