The FDA has granted several exemptions to its Medical Device Reporting requirements related to events identified in certain real-world data sources, such as medical device registries.
“Content of Human Factors Information in Device Marketing Submissions” and “Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers” are now open for comment.
The position paper from the European Commission’s Medical Device Coordination Group (MDCG) recommends an extended timeline to allow certain MDD or AIMDD certified legacy devices to come into compliance with MDR.
The acquisition expands Veranex’s footprint for product design engineering services across the U.S., with combined company offices now in the Eastern, Central, and Western regions
Balwani was found guilty on 10 counts of wire fraud and two counts of conspiracy to commit wire fraud for misleading investors about the financial health of the healthcare startup. He faced up to 20 years in prison for each count.
The acquisition expands MilliporeSigma’s portfolio to a full range of bioreactors, from 2ml to 2000L, and adds to the company’s expertise in monoclonal antibody (mAb) process development.
“We are honored to have Dr. Lace, who is widely recognized as one of the industry’s most trusted reimbursement experts, leading our new division. He will also support all our services as our CMO.”
In addition to challenges brought by new EU MDR, Switzerland has struggled to approve and introduce new devices due to its revised national medical device ordinance, which created even tougher import hurdles.
More than 300 scientists will consider the evidence on over 25 virus families and bacteria—as well as “Disease X” (an unknown pathogen that could cause a serious international epidemic)—and recommend a list of priority pathogens that need further research and investment.
Baxter Hillrom is recalling its WatchCare Incontinence Management System (IMS) following reports that the radiofrequency emissions (RF) from WatchCare devices may interfere with other medical devices.
