A long-overdue push to reduce administrative friction, improve access to patient data, and move the system away from ...
FDA and CMS each play a critical role in getting new medical devices to patients, and they work most effectively when aligned ...
Having already set expectations around the structured capture of medical device safety data, regulators are now ready to analyze related insights, and they expect device manufacturers to match this ...
As generative AI becomes embedded in clinical research, concerns around hallucinated citations and unverified outputs are ...
Stryker signs definitive agreement to acquire Amplitude Vascular Systems to add next-generation IVL technology to peripheral ...
Traditionally, contract negotiation has been viewed as a financial or legal responsibility, typically led by finance teams, ...
The FDA has approved the NEXUS Aortic Arch Stent Graft enabling commercial launch of the NEXUS System in the US. Endospan announced that the U.S. Food and Drug Administration (FDA) has approved the ...
Allevion Medical announced the FDA 510(k) clearance of Vantage, a fully disposable, sterile system designed to simplify and enhance minimally invasive lumbar decompression procedures associated with ...
Serenity Medical announced FDA Humanitarian Device Exemption (HDE) approval for its novel River stent. The River stent is for the treatment of severe idiopathic intracranial hypertension (IIH) in ...
New set of 73 Real World Evidence examples illustrate how RWD can support rigorous validation of novel device software functions across multiple disease areas. By: Daniel Caños, Ph.D., MPH, Director, ...
The acquisition expands Merit’s portfolio of therapeutic oncology products dedicated to the accurate diagnosis and localization of breast and soft tissue tumors. Merit Medical Systems, Inc. announced ...
In this part 2 of a 4-part series, Melissa highlight how the moment AI begins to influence decisions or workflows, it is operating within a regulated environment. Aligning with documentation standards ...
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