Page 14 - Breakthrough Device News Today

Andreas Forsland, the founder and CEO of Cognixion, at his company’s Santa Barbara headquarters. The company recently closed a $12 million funding round. (Eric Isaacs photo) Santa Barbara-based Cognixion has received a Breakthrough Device designation from the U.S. Food and Drug Administration, the company announced on May 4, paving the way to get its artificial

U.S. FDA Breakthrough Device designations are granted to expedite the review of technologies with the potential to greatly impact those suffering from life...

Except for statements of historical fact, certain information described in this Form 10-Q report contains forward-looking statements that involve substantial risks and uncertainties. You can identify... | May 4, 2023

The Centers for Medicare & Medicaid Services (CMS or Agency) on April 10, 2023, published its annual proposed rule for the federal fiscal year (FY) 2024...

Blood-based measurement of neurofilament light chain provides compelling evidence to support an accelerated drug approval by the FDA. The decision has positive implications for NfL blood testing as... | June 18, 2023

SYDNEY, April 19, 2023 /PRNewswire/ — Medical device company Baymatob has successfully completed one of Australia’s largest maternity health studies...

/PRNewswire/ -- Medical device company Baymatob has successfully completed one of Australias largest maternity health studies for a medical device, enrolling...

/PRNewswire/ -- Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Monday, the FDA granted...

The Centers for Medicare & Medicaid Services (CMS or Agency) on April 10, 2023, published its annual proposed rule for the federal fiscal year (FY) 2024 Inpatient Prospective Payment...

Designation represents progress for patients with suspected Coronary Microvascular Dysfunction as the FDA recognizes disease’s debilitating impacts and the lack of effective non-invasive options for efficient diagnosis