Food and Drug Administration (FDA) News This is an RSS file. You can use it to subscribe to this data in your favourite RSS reader or to display this data on your own website or blog.

FDA issues alert on heart pump associated with 49 deaths
The Food and Drug Administration issued its highest-level alert this month about a heart pump associated with reports of 49 deaths and dozens of serious injuries, sharing updated instructions from the device’s maker to doctors on how they should use the device. The Impella pumps are tiny devices…#abiomed #fda #medtech #audraharrison #johnsonmedtech #massachusetts (Source: Reuters: Health)
Source: Reuters: Health - March 30, 2024 Category: Consumer Health News Source Type: news

FDA Roundup: March 29, 2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 29, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA Roundup: March 29, 2024
SILVER SPRING, Md., March 29, 2024 /PRNewswire/ -- Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Thursday, the FDA made several updates to the Mammography Quality Standards Act and Program section on the FDA Website to... (Source: PRWeb: Medical Pharmaceuticals)
Source: PRWeb: Medical Pharmaceuticals - March 29, 2024 Category: Pharmaceuticals Source Type: news

FDA Issues Alert on Heart Pump Linked to Deaths
The agency faulted the device maker for delayed notice of mounting complications, citing increasing reports of how use of the device perforated the walls of the heart. (Source: NYT Health)
Source: NYT Health - March 29, 2024 Category: Consumer Health News Authors: Christina Jewett Tags: Medical Devices Consumer Protection Heart Deaths (Fatalities) Implants Food and Drug Administration impella Abiomed Inc Johnson & your-feed-healthcare Source Type: news

High-Strength Lidocaine Skin Creams Can Cause Seizures, Heart Trouble, FDA Warns
FRIDAY, March 29, 2024 -- Some pain-relieving skin products contain potentially harmful doses of the numbing agent lidocaine and should be avoided, the U.S. Food and Drug Administration warns.These creams, gels, sprays and soaps are marketed for... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - March 29, 2024 Category: General Medicine Source Type: news

Americans strongly back abortion pill access and FDA drug review powers
Data: Axios/Ipsos; Chart: Tory Lysik/Axios Visuals More than 7 in 10 Americans support access to medication abortion, and even more back the Food and Drug Administration's ability to regulate drugs, a new Axios-Ipsos poll finds. Why it matters: The findings suggest a Supreme Court decision that…#chart #supremecourt #fda #postroe #republicans #ipsos #mallorynewall #alabamasupremecourt #ivf #democrats (Source: Reuters: Health)
Source: Reuters: Health - March 29, 2024 Category: Consumer Health News Source Type: news

Founders of Collierville startup CircumFix Solutions look ahead to commercialization
In January, the startup received 510(k) clearance from the Food and Drug Administration (FDA), which allows for commercial activities. (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - March 29, 2024 Category: Biotechnology Authors: Jason Bolton Source Type: news

FDA Expands Indication for Gilead's Vemlidy (tenofovir alafenamide) to Treat Chronic HBV Infection in Pediatric Patients as Young as Six
March 28, 2024 -- FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for Vemlidy® (tenofovir... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 28, 2024 Category: Drugs & Pharmacology Source Type: news

FDA Approves Winrevair for Pulmonary Arterial Hypertension in Adults
THURSDAY, March 28, 2024 -- The U.S. Food and Drug Administration has approved Winrevair (sotatercept-csrk) as an injectable treatment for pulmonary arterial hypertension (PAH) in adults.The FDA previously granted Winrevair a breakthrough therapy... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - March 28, 2024 Category: Pharmaceuticals Source Type: news

SyntheticMR secures U.S. clearance for SyMRI 3D
Sweden-based company SyntheticMR has secured 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its SyMRI 3D software. SyMRI 3D offers quantitative MRI capability for MRI brain imaging. The software enables volumetric estimations of brain regions, a technique commonly referred to as parcellation, which can provide clinicians insights into brain structure and function. Furthermore, the resolution provided by SyMRI 3D facilitates comprehensive lesion analysis, the company said. (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - March 27, 2024 Category: Radiology Authors: AuntMinnie.com staff writers Tags: Industry News Neuroradiology Source Type: news

Siemens secures FDA clearance for Terra.X
Siemens Healthineers has received U.S. Food and Drug Administration (FDA) clearance for its Magnetom Terra.X 7-tesla MRI scanner. First showcased at RSNA 2022, Terra.X is a clinical 7-tesla system with eight-channel, parallel transmit architecture. It features what Siemens calls Ultra IQ technology – new hardware and software that has increased homogeneity and enabled a larger field of view, the company said. Ultra IQ is designed to exploit the resolution and contrast possible with 7-tesla scanning, according to the vendor. Terra.X succeeds Siemens’ Terra clinical 7-tesla scanner, which was introduced in 2017. The FD...
Source: AuntMinnie.com Headlines - March 27, 2024 Category: Radiology Tags: Product News Source Type: news

Synaptive receives U.S. clearance for Modus IR
The Modus X robotic exoscope. Image courtesy of Synaptive.Toronto, Canada-based firm Synaptive Medical has received U.S. Food and Drug Administration clearance for Modus IR, a near-infrared fluorescence visualization module on its Modus X robotic exoscope.The clearance bolsters the capabilities of Synaptive’s exoscope for use across all neurosurgical procedures, as well as in plastic and ENT surgery, the company said. The newly approved IR mode is used for visualizing indocyanine green (ICG) fluorescent dye. ICG causes blood to fluoresce under infrared light and is used to aid in the visualization of vessels and blood fl...
Source: AuntMinnie.com Headlines - March 27, 2024 Category: Radiology Authors: AuntMinnie.com staff writers Tags: Industry News Source Type: news

Roche receives FDA approval for the first molecular test to screen for malaria in blood donors
The cobas Malaria test is the first FDA-approved molecular test to screen U.S. blood donors for malariaMalaria is a serious and potentially fatal parasitic infection most commonly transmitted by mosquitoes that can also be spread through blood transfusionRoche is dedicated to saving patients ’ lives through diagnostic solutions that aid in the protection of the global blood supply from infectious diseasesBasel, 26 March 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the U.S. Food and Drug Administration (FDA) approval of the cobas® Malaria test for use on the cobas® 6800/8800 Systems. This approved test ca...
Source: Roche Media News - March 26, 2024 Category: Pharmaceuticals Source Type: news

FDA Approves Winrevair (sotatercept-csrk) a First-in-Class Treatment for Adults with Pulmonary Arterial Hypertension
RAHWAY, N.J.--(BUSINESS WIRE) March 26, 2024 -- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has approved sotatercept-csrk (U.S. Brand Name:... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 26, 2024 Category: Drugs & Pharmacology Source Type: news

FDA approves Merck's drug for rare, deadly lung condition
Exterior view of the entrance to Merck headquarters on February 05, 2024 in Rahway, New Jersey. The Food and Drug Administration on Tuesday approved a drug from Merck designed to treat a progressive and life-threatening lung condition in a win for both the drugmaker and for patients suffering from…#merck #rahway #newjersey #winrevair #pah #keytruda #jpmorgan #chrisschott #merckchiefmedical #eliavbarr (Source: Reuters: Health)
Source: Reuters: Health - March 26, 2024 Category: Consumer Health News Source Type: news