Devices

CDRH Authorized 120 Novel Devices in 2024

In 2024, CDRH granted marketing authorization to 120 novel devices, which was four less than the previous year’s record-setting 124 devices, according to the Center’s just-released 2024 annual report. The Center also continues to see increasing interest from developers to bring their novel technologies to market first in the U.S or in parallel with other major countries. In 2024, 65% of novel devices were first introduced in the U.S., which is up from 55% that were first marketed in the U.S. in 2022, according to the report.

“Many of these novel devices address an unmet need or may be safer or more effective than currently available alternatives,” CDRH says. “This includes the first over-the-counter (OTC) test to detect both flu and Covid-19. Novel device authorizations demonstrate how timely and effective interactions between the FDA and sponsors can help ensure that patients and providers have timely and continued access to safe, effective, and high-quality medical devices.”

Additionally, CDRH says it worked in 2024 to further promote the use of real-world data and real-world evidence (RWE) in lieu of conventional clinical trial data to reduce the time to answer important device questions. “We have authorized more than 180 devices, at least in part on the basis of RWE — with 50 in FY2024,” it says. “These represent important advancements for patients who need safe and effective options to improve and extend their lives.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome