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

A federal judge in Texas has blocked the FDA’s plans to bring laboratory-developed tests under the same regulations it uses ...

Withings . Withings has announced its BPM Vision blood pressure monitor will be available in the U.S. from April 2, having cleared the Food and Drug Administration (FDA)’s strin ...

Some U.S. health regulators who review medical devices and tobacco products for safety and efficacy are struggling to meet ...

Critics worry that the user fee program creates a conflict of interest between the FDA and pharmaceutical companies.

The World Health Organization recognises the test as the “only” enzyme-linked immunospot-based interferon-gamma release assay.

Imricor has achieved another key milestone with the second module for premarket approval of its devices submitted to the US FDA. Imricor Medical Systems (ASX:IMR) – which has developed the world ...

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

TCET is meant to expedite Medicare coverage for new medical devices once approved by the FDA. The program ... Oz agreed that more could be done to speed up the Medicare coverage process for new ...

Imricor Medical Systems (ASX:IMR) – which has developed the world’s only MRI-compatible devices for cardiac ablations – said the second module, focused on quality manufacturing processes, is ...