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Several advocacy groups have written to the House Energy and Commerce Committee and its Subcommittee on Health to defend the “right to repair” devices and push back against what they view as moves to restrict it. Read More
German device manufacturer Fresenius Kabi is acquiring Massachusetts-based infusion system manufacturer Ivenix in a purchase deal that includes $240 million upfront and future milestone payments. Read More
DermaSensor’s optical spectroscopy device has demonstrated a 96 percent melanoma detection rate and a negative predictive value of 98.1 percent in a clinical trial, the company said. Read More
In an effort to address differing definitions of the term “digital biomarker” and improve discussions on medical product development, FDA officials have penned an article meant to clear up misconceptions and spur alignment toward the agency-endorsed definition. Read More
The interns may assist senior reviewers in obtaining and reviewing technical data and material related to device submissions, the agency said. Read More
The FDA has asked Congress to consider several proposed authorities that would affect medical device developers, manufacturers and distributors. 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 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
The FDA is considering how to offer more regulatory flexibility for medical device software, said Jeff Shuren, director of FDA’s Center for Devices and Radiological Health (CDRH). Read More
Unimicro Medical Systems has been sent an FDA warning letter for failing to comply with the agency’s Quality System Regulation (QSR) in manufacturing needles used in laparoscopic surgery. Read More
After a long delay, the FDA said it has finally reached an agreement with medical device representatives on proposed recommendations for the fifth reauthorization of the Medical Device User Fee Act (MDUFA). Read More