Page 4 - Breakthrough Devices News Today

Centers for Medicare & Medicaid Services CMS proposed rule would repeal Medicare Coverage of Innovative Technology & Definition of Reasonable and Necessary MCIT/R&N final rule; pathway to provide national Medicare coverage of medical devices designated Breakthrough Devices by Food and Drug Administration FDA

Mojo Vision, a California-based startup, is developing an electronic contact lens that can digitally enhance what the wearer sees. The company intends for Mojo Lens’ initial application to be as an assistive device to help people with sight impairments see the world in an entirely new way.

Perimeter Medical Imaging AI, Inc. a medical technology company driven to transform cancer surgery with ultra-high-resolution, real-time, advanced imaging tools to address high unmet medical needs, today reported financial results for its first quarter ended March 31, 2021 and provided a corporate update. Jeremy Sobotta, Perimeter’s Chief Executive Officer stated, “Supported by a strong balance sheet and a ...

Perimeter Medical Imaging AI Reports 2020 Financial Results and Provides Corporate Update Perimeter Medical Imaging AI, Inc. a medical technology company driven to transform cancer surgery with ultra-high-resolution, real-time, advanced imaging tools to address high unmet medical needs, today reported financial results for the year ended December 31, 2020 and provided a corporate update. Jeremy Sobotta, Perimeter’s Chief Executive Officer stated, “In 2020, we achieved a number of key milest...

Boston Scientific Announces Results For First Quarter 2021 News provided by Share this article Share this article MARLBOROUGH, Mass., April 28, 2021 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) generated net sales of $2.752 billion during the first quarter of 2021. This represents growth of 8.2 percent on a reported basis, 5.6 percent on an operational 1 basis and 5.9 percent on an organic 2 basis, all compared to the prior year period. The company reported GAAP net income availab...

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...

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.