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

One of my provisions allows the FDA to tap a deeper well of expertise from the medical device industry during the approval process. Many of these devices are extremely complex and require ...

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

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

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.