Posts by cstephenson@legacymedsearch.com
Life Spine Announces FDA 510(k) Clearance of the Titanium Stand-Alone ALIF Spacer System
Life Spine, a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders, announced today that it has received clearance from the U.S. Food & Drug Administration (FDA) to market the Titanium Stand-Alone ALIF Spacer System. “This system clearance is the capstone on a year of incredible product…
Read MoreOpsens Inc. Announces 510(k) Clearance from the FDA to Market its Diastolic Pressure Algorithm
Opsens Inc. announces 510(k) clearance from the U.S. Food and Drug Administration (“FDA”) to market its diastolic pressure algorithm (“dPR”). Coronary physiology has been in constant evolution with the expanded use of Fractional Flow Reserve (“FFR”) and the support of strong clinical data and cardiology societies recommendations. More recently, the option for coronary physiology without hyperemia…
Read MoreIRRAS Receives Renewed CE Mark for the IRRAflow Catheter
IRRAS, a global healthcare company with a comprehensive portfolio of innovative products for neurocritical care, announced today that it received CE Mark approval for its IRRAflow®catheter. This CE Mark complements the two CE Marks previously obtained for the IRRAflow system’s tube set with digital pump and control unit, and allows IRRAS to once again commercially market the IRRAflow system in…
Read MoreBaebies Announces CE Mark for FINDER, an Innovative Near-Patient Testing Platform for Glucose-6-Phosphate Dehydrogenase
Baebies is pleased to announce that FINDERTM, a near-patient testing platform, now has CE Mark as an In Vitro Diagnostic device (IVD) and is commercially available in Europe and other countries that recognize CE Mark. The CE-Marked platform includes an instrument and a cartridge, which tests for Glucose-6-Phosphate Dehydrogenase (G6PD) from low blood volume, a single drop…
Read MoreMedtronic Expands Surgical Synergy(SM) with FDA Clearance of the Stealth Autoguide System for Cranial Procedures
Medtronic plc announced that the U.S. Food and Drug Administration (FDA) recently cleared the Stealth Autoguide™ system, the first cranial robotic platform that integrates with Medtronic’s enabling technology portfolio to create an end-to-end procedural solution. The Stealth Autoguide Platform is a robotic guidance system intended for the spatial positioning and orientation of instrument holders or…
Read MoreClinical Study Utilizes the myTAIHEART Test to Monitor Cell-Free DNA Levels, 2-10 Days Post-Transplantation, in Pediatric Heart Transplant Recipients
TAI Diagnostics, Inc., focused on developing innovative diagnostic tests for monitoring the health of transplanted organs, today announced the publication of “Early Changes in Cell-Free DNA Levels in Newly Transplanted Heart Transplant Patients” in the December 11th open access version of Pediatric Transplantation, the official journal of the International Pediatric Transplant Society. The publication provides results from a prospective…
Read MoreFDA Clears Two Siemens Healthineers CT Systems Dedicated for Radiation Therapy Planning
The U.S. Food and Drug Administration (FDA) has cleared the SOMATOM go.Sim and SOMATOM go.Open Pro – two computed tomography (CT) systems from Siemens Healthineers that are dedicated for radiation therapy (RT) planning. The 64-slice SOMATOM go.Sim and 128-slice SOMATOM go.Open Pro are members of the SOMATOM go. platform, which was created to limit potential…
Read MoreFDA Approves Diffusion-Weighted Images for Elekta Unity, Expanding Options for Assessment During Therapy
Elekta today announced that it has received 510(k) premarket notification from the U.S. Food and Drug Administration for the use of diffusion-weighted MR images (DWI) obtained with Elekta Unity to be interpreted by a trained physician. This expands the clinical utility of Elekta Unity to include biologic assessment of tumor response during therapy, allowing treatment…
Read MoreFirst Patient Enrolls in New Trial for Abiomed’s Impella Looks for Heart Failure Reduction
Abiomed (NASDAQ: ABMD) announces initiation of the ST-Elevation Myocardial Infarction Door-to-Unloading (STEMI DTU) Pivotal Randomized Controlled Trial (RCT), which will explore whether unloading the heart’s left ventricle for 30 minutes with an Impella heart pump prior to opening blocked arteries will reduce infarct size after a heart attack and lead to a reduction in future heart failure rates.…
Read MoreAptar’s Nasal Unidose Device Approved by U.S. FDA for First Nasal Rescue Treatment for Frequent Seizure Activity
AptarGroup, Inc., a global leader in drug delivery, consumer product dispensing and active packaging solutions, today announced that its patented Unidose Liquid System is the device delivering the first and only nasal rescue treatment approved by the U.S. FDA, which has recently launched in the U.S. to treat acute repetitive seizures in people living with…
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