The FDA says the device, designed to repair broken blood vessels to stem bleeding, showed a “clinically meaningful benefit.” ...

According to the FDA’s public database, since the start of this year, the agency has issued only two de novo medical device ...

Imricor Medical Systems (ASX:IMR) – which has developed the world’s only MRI-compatible devices for ... the US Food and Drug Administration’s (FDA’s) premarket approval (PMA) process ...

Imricor is executing a modular review process with the FDA, whereby modules covering ... is involved due to the number of devices for which we are seeking approval simultaneously.

The agency OK’d an artificial vessel to restore blood flow in patients, even though its own scientists flagged questionable ...

Mehmet Oz, President Trump’s pick to lead the CMS, said Medicare beneficiaries should have quicker access to new medical ...

Aligning with global CMC standards can help to minimize these inefficiencies, allowing pharmaceutical companies to expedite the approval process, reduce developmental costs, and achieve quicker ...

A quality management system (QMS) can often become bloated and unwieldy. This expert helps you understand key QMS basics and ...

Attorney Simon Purnell of Griffin Purnell said he thinks the courts' view of preemption is a "fundamental misunderstanding of ...

Hyperbaric chambers are not an approved therapy for ... could help with," she said. The FDA regulates the oxygen used in ...

“I believe in the scientific process ... FDA employees were among thousands of probationary workers fired from the HHS last month, however, some employees overseeing areas including medical ...