JD Supra14h
FDA Dumps Trio of Device-Related Guidances Prior to Administration Change
Among the wave of guidance documents issued by the U.S. Food and Drug Administration (“FDA” or the “Agency”) in the first week of 2025 were ...
STAT5d
FDA purges material on clinical trial diversity from its site, showing stakes of Trump DEI ban
Following the Trump administration's DEI ban, the FDA's move to scrub webpages has ensnared many pages focused on ensuring ...
FierceBiotech11d
FDA's device chief calls for more authority to address supply chain shortages impacting pediatric, neonatal patients
While medical device shortages are nothing new, the FDA said it is becoming more concerned that supply chain disruptions are ...
Hosted on MSN11h
FDA grants 510(k) clearance for Imperative Care’s stroke thrombectomy system
The US Food and Drug Administration (FDA) has granted 510(k) clearance for Imperative Care’s Zoom System, marking an ...
medtechdive1d
FDA webpages on clinical trial diversity removed after Trump orders
The website changes raise concerns about “the interference of politics with the study and the practice” of science and ...
The National Law Review7d
FDA Issues New Recommendations on Use of AI for Medical Devices, Drugs, and Biologics
In its most recent effort to keep pace with advancing technology, the US Food and Drug Administration (FDA) recently issued ...
Medical Design and Outsourcing4d
FDA’s Tarver pushes for mandatory medical device shortage reporting
The FDA is urging Congress to implement mandatory medical device shortage reporting to address growing vulnerabilities in the ...
Hosted on MSN3h
Merit Medical Celebrates FDA Approval of WRAPSODY™
An update from Merit Medical Systems ( ($MMSI) ) is now available. On January 28, 2025, Merit Medical Systems held a conference call to discuss ...
medtechdive4d
Sara Brenner named acting FDA commissioner
Brenner, who worked in the FDA’s Center for Devices and Radiological Health, will take the helm of the agency until a new ...
US FDA drops web pages on improving clinical trial diversity
The U.S. Food and Drug Administration has pulled draft guidance from its website requiring companies to test medicines and ...
FierceBiotech13d
FDA elevates Philips cardiac telemetry recall over unflagged ECG alerts, following 2 deaths
The FDA is elevating a recall from Philips related to one of its wearable outpatient heart monitors, used to help detect ...
STAT11d
How the FDA and CMS worked together on a new approach to paying for digital mental health treatments
By establishing coding and separate payment for certain digital mental health devices, this group from CMS and the FDA hopes ...