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

Calgary-based healthtech startup RetinaLogik has closed $1.1 million CAD in convertible note financing and secured a Class II medical device licence from Health Canada. Now, armed with regulatory ...

The United States’s Food and Drug Administration (FDA), which regulates all medicines and medical devices ... regulatory review and the potential for a faster approval process.

Key factors propelling the growth of the medical suction devices market include the increasing prevalence of chronic respiratory diseases, such as COPD and asthma, and a rise in surgical procedures ...

FDA recently issued two draft guidance documents discussing: (1) the use of artificial intelligence (AI) to produce information to support a regulatory ... approval for medical devices containing ...

In the segment of medical technologies, its offering includes vital disposables, infusions pumps, apheresis machines, cell therapy devices, and more ... the research and development, the regulatory ...

Our test devices ... regulatory framework shapes product decisions, it dictates what you build, in what order, and also how you position your offering. Documentation is key, as clear, detailed records ...

Indeed, in new draft guidance on the use of AI to support regulatory ... of the diagnostic process and is therefore inclined to regulate screening software tools as medical devices, as well.

The FDA’s Breakthrough Device is a voluntary program for manufacturers of medical and ... prioritised regulatory review and, potentially, a faster approval process. In addition, the start ...

"Seeing is believing," the founder of lab company Truvian told me. So I tried its tabletop blood testing device—which ...

Under the approval process ... this was under an old scheme called the Medical Device Directive, which was phased out in favour of the Medical Device Regulation. For Monty Python fans, this ...