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 ...
According to the FDA’s public database, since the start of this year, the agency has issued only two de novo medical device ...
Some U.S. health regulators who review medical devices and tobacco products for safety and efficacy are struggling to meet ...
The first Trump administration proposed a rule in 2020 that would have guaranteed four years of Medicare coverage to breakthrough medical devices approved by the FDA. The Biden administration ...
The Food and Drug Administration recently issued a Warning Letter concerning unauthorized modifications made to a previously cleared medical ...
The FDA’s latest ... Accelerated Approval of Drugs and Biologics,” is a game-changer for biopharmaceutical companies hoping to bring life-saving treatments to market. If you’re navigating the ...
The FDA says the device, designed to repair broken blood vessels to stem bleeding, showed a “clinically meaningful benefit.” ...
Most notably, 226 of 521 FDA-approved medical devices, or approximately 43% ... that automates the organ donor evaluation and ...
A 1992 law called the Prescription Drug User Fee Act was primarily intended to fast-track the time between applying for approval and ... fee programs for medical devices, generic drugs, biosimilar ...
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 ...
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