Medtronic plc received U.S. FDA approval for the expanded redo TAVR indication of the Evolut transcatheter aortic valve replacement system. The approval allows for valve-in-valve implantation of a new Evolut valve inside a failed previously implanted TAV made by any manufacturer in patients with severe aortic stenosis considered high-risk for open-heart surgery. Read More
The U.S. Department of Health and Human Services reported Aug. 27 that Susan Monarez no longer occupies the post of director for the CDC, a development that arose within hours of the FDA’s approval of two COVID-19 vaccines with historically restrictive labeled indications. Read More
Telix Pharmaceuticals Ltd. received an FDA complete response letter (CRL) a day after the Aug. 27 PDUFA date for its BLA for radiopharmaceutical renal cancer imaging agent, Zircaix (TLX250-CDx, 89Zr-DFO-girentuximab). Read More
Recently launched Irish startup Phyxiom Ltd. hopes that its digital health platform will transform the clinical outcomes for patients with asthma and chronic obstructive pulmonary disease. By providing clinicians with real-time insights into lung function and medication adherence, the platform improves diagnosis accuracy and treatment outcomes. Read More
New research has filled in missing links between gene variants that have been implicated in disease through genome-wide association studies and how the variants drive disease pathology. The research involved using induced pluripotent stem cells derived from healthy donors and transforming them into macrophages. These were then exposed to 24 different stimuli mimicking infection and inflammation, and the gene expression profiles assessed six and 24 hours later, to see which genes were turned on or off in response. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Airiver Medical, Association of Medical Device Reprocessors, Bioporto, Catheter Precision, Johnson & Johnson, Positron, Roche. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Medtronic. Read More
