In the United States, the biomedical industry encounters numerous regulatory challenges in conducting nonclinical and ...

Innovators wanting to market their products must first review the existing HA regulatory framework for medical devices to determine the correct pathway. The first step is to assess whether or not ...

The Centers for Medicare and Medicaid Services ("CMS") published a final notice outlining the processes and procedures for the Transitional ...

Medical technology company Stryker (NYSE:SYK) reported revenue ahead of Wall Street’s expectations in Q4 CY2024, with sales ...

Centres of Excellence for Regulatory Science and Innovation (CERSIs) to help drive advancements in healthcare.Pioneering use of artificial intelligence (AI) could cut the time it takes to bring ...

Healthcare product and device company Abbott Laboratories (NYSE:ABT) met Wall Street’s revenue expectations in Q4 CY2024, ...

Another critical issue is the regulatory pathway for medical devices in the United States, particularly the 510(k) pathway, which allows new devices to be authorized based on their similarity to ...

Getting a medical diagnostic tool to market can take between three to seven years due to the strict regulatory requirements.

Abhishek Pandurang Benke led the development of an innovative cardiovascular diagnostic device, improving accuracy, speed, ...

Several ASX-listed companies are undertaking phase III clinical trials, the critical final stage before potential regulatory ...

New documents clarify how the FDA plans to regulate AI-enabled devices, experts say, but several important questions remain ...