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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 Research and Innovation, and Clinical Professor of Medicine at Indiana University, commented, "This ...

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 “operationalize” the program, which is a voluntary program applicable to “certain medical devices and devic...

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.