Page 14 - Breakthrough Devices Program News Today

Shoshanna Solomon is The Times of Israels Startups and Business reporter The technology developed by IceCure Medical Ltd. destroys tumors by freezing them in a minimally invasive procedure with no surgery or hospitalization requirement (Courtesy) IceCure Medical, an Israel-based maker of tumor-freezing technology, said Sunday that it had received notification from the US Food and Drug Administration recognizing its ProSense product as a “breakthrough device” to freeze tumors in a number of...

Share this article Share this article PORTLAND, Ore., Feb. 23, 2021 /PRNewswire/ -- Inovise Medical today announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation for its AUDICOR ® heart failure management system. The system uses clinically tested algorithms to detect the risk of decompensation at home in patients who have been previously hospitalized for heart failure. Inovise Medical, Inc. Michael Mirro, MD, Director of the Parkview Mirro Center for ...

With Release Of New Guidance Document, FDA Launches Safer Technologies Program for Medical Devices By Mark Durivage, Quality Systems Compliance LLC The FDA’s Center for Devices and Radiological Health (CDRH) releasedthe Safer Technologies Program for Medical Devices (STeP) Guidance for Industry and Food and Drug Administration Staff on January 6, 2021, with plans to begin accepting applications for STeP beginning March 8, 2021. The two-month delay is due to the expected time to “operationa...

WOLHUSEN, Switzerland--(BUSINESS WIRE)--Geistlich Pharma, a Swiss developer of biomaterials for regenerative therapies in orthopedics, announced that the Chondro-Gide® articular cartilage cover has been granted a Breakthrough Device Designation (BDD) from the U.S. Food and Drug Administration. Chondro-Gide® is a col...

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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 Administratio...

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 Janu...

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 avail...

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...