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 ...

Stryker signs definitive agreement to acquire Amplitude Vascular Systems to add next-generation IVL technology to peripheral ...

As generative AI becomes embedded in clinical research, concerns around hallucinated citations and unverified outputs are ...

Traditionally, contract negotiation has been viewed as a financial or legal responsibility, typically led by finance teams, ...

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 ...

Device Makers are currently at an intersection of accelerated innovation and heightened regulatory scrutiny. Regulatory affairs stands in the center guiding operational resilience and a coherent ...

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 ...

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 ...

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, ...

Companies that embed Market Access early in innovation are the ones best positioned to navigate the changing global landscape. Across industry, the Market Access (MA) function has evolved well beyond ...