News and Updates about the regulations in Medical Devices Rules
Zimmer Biomet (NYSE:ZBH) today announced it has obtained 510(k) clearance from the FDA for its Persona SoluTion porous plasma spray femur. This innovative knee implant component provides a beneficial option for individuals who are sensitive to traditional bone cement and/or […]
Zimmer Biomet Secures FDA Approval for New Knee Implant Component Read More »
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 »
Movano Health (Nasdaq:MOVE) has announced securing FDA 510(k) approval for the pulse oximetry function within its EvieMED Ring. This clearance paves the way for Movano to explore further opportunities in health monitoring solutions, targeting applications like clinical trials, post-trial management,
Movano Gains FDA Approval for EvieMED Ring’s Pulse Oximetry Function Read More »
Nonin Medical has successfully obtained FDA 510(k) approval for its inaugural over-the-counter fingertip pulse oximeter, the TruO2 OTC. Starting this month, the device will be available for purchase on Amazon, with broader online retail availability expected soon. The FDA has
FDA Approves Nonin’s Tru02 OTC Pulse Oximeter for Consumer Use Read More »
GE HealthCare (Nasdaq:GEHC) has revealed its plans to purchase the remaining 50% interest in Nihon Medi-Physics, making it the sole owner of the Japanese radiopharmaceutical enterprise. This transaction, orchestrated with Sumitomo Chemical, is anticipated to be finalized by early 2025,
GE HealthCare Set to Acquire Full Control of Nihon Medi-Physics Read More »