AI’s reach depends on the environments in which it operates as well as how it is developed and deployed, highlighting a ...

Evolving regulations and market requirements have kept medtech companies on their toes for years. EU MDR, for example, has ...

Under IVDR, clear and specific IVD intended use criteria are required and introduce significant challenges for manufacturers ...

Up until now, the lack of interoperable health-at-home devices has inhibited health technology integration into the home for use in wellness, prevention, managing chronic conditions, and clinical ...

On February 15, numerous probationary staff at FDA began receiving emails notifying them they had been fired. "Unfortunately, the Agency finds that you are not fit for continued employment because ...

Holmes appears to be headed for prison after an appeals court rejected her bid to remain free while she tries to overturn her conviction in a blood-testing hoax that brought her fleeting fame and ...

As the saying goes, if it looks too good to be true, it probably is.

Medical Device reimbursement levels in Japan are now more in line with the reimbursement levels in the EU. The Japanese government has pledged not to allow Japanese device reimbursement to be as high ...