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

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

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.

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 ...

The U.S. Food and Drug Administration granted marketing authorization for the first home-based, nonprescription diagnostic test for chlamydia, gonorrhea, and trichomoniasis in women, the agency ...

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.

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 ...