Page 28 - Breakthrough Devices Program News Today : Breaking News, Live Updates & Top Stories | Vimarsana

Pedra Tissue Perfusion System Receives FDA Breakthrough Device Designation Novel perfusion monitor allows real-time, periprocedural monitoring of tissue perfusion in patients with critical limb threatening ischemia The Pedra Blood Perfusion Index tracks real-time changes in foot tissue perfusion attendant with balloon inflation and deflation during an angioplasty procedure. January 26, 2021 — Pedra Technology, a privately held company, announced today that the U.S. Food and Drug Administration (FDA) has granted the company a Breakthrough Device Designation for the periprocedural use of its ...

To embed, copy and paste the code into your website or blog: Considering the tight timeline for preparing responses to FDA compliance actions coupled with the agency’s expectation for timely implementation of corrective and preventive actions, the benefit of obtaining feedback through the Q-submission program (also referred to as a “pre-submission”) may be limited. To start off the new calendar year, FDA issued a revised version of its guidance document on the Q-submission program on January 6, 2021, “ Obtaining feedback on submissions that may qualify for FDA’s recently announced S...

To embed, copy and paste the code into your website or blog: On January 6 of this year, the Food and Drug Administration (FDA) released a final guidance on the Safer Technologies Program (STeP) for Medical Devices. The concept of STeP was first introduced by FDA in 2018 with the goal of expediting development and FDA review of medical devices or device-led combination products that are likely to offer safer treatment or diagnosis of certain diseases and conditions as compared to currently available alternatives. Such alternatives may include currently marketed medical devices or other standar...

The agency has finalized a rule that allows it to provide immediate Medicare coverage for FDA-approved products that are deemed "breakthrough devices." The new coverage process would enable seniors to get access to these devices more quickly, but some provider and payer groups are concerned that this could cause patient harm.

On January 6, 2021, the U.S. Food and Drug Administration (FDA) published a final guidance outlining the Safer Technologies Program (STeP) for Medical Devices: a voluntary program for...