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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

US FDA Approves Merck's Therapy for Rare Lung Condition US FDA Approves Merck's Therapy for Rare Lung Condition
The U.S. Food and Drug Administration on Tuesday approved Merck ' s treatment for adults with high blood pressure due to constriction of lung arteries, adding another...Reuters Health Information (Source: Medscape Cardiology Headlines)
Source: Medscape Cardiology Headlines - March 26, 2024 Category: Cardiology Tags: Pulmonary Medicine Source Type: news

FDA Approves Medexus's Supplemental Biologics License Application for Ixinity to Treat Hemophilia B in Pediatric Patients
Toronto, Ontario and Chicago, Illinois-- March 26, 2024 - Medexus Pharmaceuticals (TSX: MDP) (OTCQX: MEDXF) today announced that the US Food and Drug Administration (FDA) recently approved Medexus ' s supplemental Biologics License Application (sBLA)... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 26, 2024 Category: Drugs & Pharmacology Source Type: news

Key Takeaways From Supreme Court Arguments on Abortion Pill Access
Several justices questioned the remedy of applying nationwide restrictions to mifepristone because it would be the first time a court had second-guessed the F.D.A. ’s regulatory authority. (Source: NYT Health)
Source: NYT Health - March 26, 2024 Category: Consumer Health News Authors: Pam Belluck Tags: United States Politics and Government Abortion Supreme Court (US) Food and Drug Administration Drugs (Pharmaceuticals) Gorsuch, Neil M Barrett, Amy Coney Jackson, Ketanji Brown (1970- ) Thomas, Clarence Source Type: news

FDA Roundup: March 26, 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 26, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Avicenna.AI secures FDA clearance for CINA-iPE and CINA-Aspects
Medical imaging AI company Avicenna.AI has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its CINA-iPE and CINA-Aspects software. CINA-iPE is an AI-powered tool that detects incidental pulmonary embolism during routine CT scans. The algorithm identifies lung blood clots detected during routine CT scans for a variety of health conditions. Scan types may include full-body scans, scans of the chest, abdomen, and pelvis, as well as scans of the thoracic area along with the abdomen and pelvis. CINA-Aspects is for stroke severity assessment, automatically processing non-contrast CT scans and cal...
Source: AuntMinnie.com Headlines - March 26, 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 Investor Update - March 26, 2024 Category: Pharmaceuticals Source Type: news

Abortion Pill Dispute Centers on Central Question: Who Can Sue?
The parties in the fight over access to the abortion pill sharply disagree on whether anti-abortion doctors and groups can show they will suffer harm. (Source: NYT Health)
Source: NYT Health - March 26, 2024 Category: Consumer Health News Authors: Abbie VanSickle and Pam Belluck Tags: Abortion Abortion Drugs Suits and Litigation (Civil) Doctors United States Politics and Government Food and Drug Administration Supreme Court (US) Source Type: news

The rise of theranostics: Part 1 -- Gaining momentum
Since the U.S. Food and Drug Administration's (FDA) approvals of radiopharmaceuticals for neuroendocrine tumors and then for prostate cancer, theranostics has picked up momentum in clinical practice, propelled by encouraging research.Theranostics pairs diagnostic biomarkers that can be visualized on nuclear medicine imaging with therapeutic agents that share a specific target in diseased cells or tissues. After the therapeutic agent binds to the cancer cells, the tumors are treated in such a way that aims to prevent collateral damage to healthy cells and improve overall outcomes.Theranostics isn’t new; nuclear medicine d...
Source: AuntMinnie.com Headlines - March 26, 2024 Category: Radiology Authors: Liz Carey Tags: Practice Management Molecular Imaging Radiation Oncology/Therapy Nuclear Medicine Source Type: news