News and Updates by the Food and Drugs Administration (FDA)
InnoCare Urologics has recently announced the achievement of receiving 510(k) clearance from the FDA for its innovative urinary safety catheter. This milestone allows the Miami-based organization to be the first to obtain FDA approval under a new classification that recognizes […]
InnoCare Urologics Gains FDA Approval for Innovative Urinary Safety Device Read More »
Beacon Biosignals today heralded the FDA’s approval of an updated algorithm for its Dreem 3S sleep monitoring headband. The FDA sanctioned the predetermined change control plan (PCCP) for the Dreem 3S, allowing for updates to the sleep staging algorithm without
FDA Greenlights Algorithm Enhancements for Beacon Biosignals’ Sleep Wearable Read More »
Distalmotion has unveiled the initial successful outpatient operations in the United States utilizing its Dexter surgical robot platform. A team of experts at UC San Diego Health triumphantly executed two adult inguinal hernia repairs on November 26, overseen by Dr.
Dexter Surgical Robot Achieves First Outpatient Success in the U.S. Read More »
GE HealthCare (Nasdaq:GEHC) revealed its recent submission of the CleaRecon DL for FDA 510(k) approval. This cutting-edge deep learning tool, developed in Chicago, enhances cone-beam CT (CBCT) image quality with AI-driven 3D reconstruction capabilities, specifically designed for use in interventional
GE HealthCare Seeks FDA Approval for CleaRecon DL Read More »
Philips (NYSE:PHG) has unveiled a partnership with Mayo Clinic focused on enhancing cardiac MRI technology through the use of artificial intelligence. With this collaboration, both Philips and Mayo Clinic aim to capitalize on AI advancements alongside expertise from Mayo Clinic’s
Philips and Mayo Clinic Partner to Enhance Cardiac MRI with AI Read More »
Haemonetics (NYSE: HAE) has revealed an agreement to transfer its whole blood division to GVS S.p.A in exchange for $67.1 million. GVS, known for its filter solutions in healthcare and life sciences, will pay an initial amount of $44.6 million.
Haemonetics Divests Whole Blood Division for $67.1 Million Read More »
Ainos Inc, a pioneering healthcare firm based in San Diego that specializes in advanced AI-enhanced point-of-care diagnostics and low-dose interferon therapies, has disclosed that it has entered into a crucial memorandum of understanding (MoU) with Taiwan Tanabe Seiyaku Co, Ltd.
AlveoGene, a company dedicated to revolutionizing treatments for rare respiratory conditions through inhaled gene therapies, has announced that its novel therapy, AVG-002, has received Orphan Drug Designation from the US Food & Drug Administration (FDA). This recognition is for AVG-002’s
### **Merck’s Latest Lung Cancer Therapy Receives FDA Breakthrough Designation** Merck, operating as MSD outside the USA and Canada, revealed that the U.S. Food and Drug Administration (FDA) has awarded a Breakthrough Therapy designation to sacituzumab tirumotecan (sac-TMT) aimed at
Orbit Discovery, a leader in peptide discovery services, and Evergreen Theragnostics, a pioneer in radiopharmaceuticals and precision medicine, today announced the extension of their research collaboration to develop innovative targeting peptides for radiopharmaceutical applications. This expansion builds on a previous