source
- Roche receives expanded FDA clearance for HER2 diagnostic tests linked to Jazz’s Ziihera cancer drugRoche announced that the U.S. Food and Drug Administration has broadened the clearance for two of its HER2 diagnostic assays, allowing their use in metastatic gastroesophageal adenocarcinoma. The…
- Medtronic and Given Imaging issue early alert for Bravo CF esophageal pH capsule delivery devices due to attachment failuresThe FDA's Center for Devices and Radiological Health issued an Early Alert about a potential high‑risk issue with Medtronic’s Bravo CF esophageal pH monitoring capsule delivery devices. The proble…fda medwatch · 1d agoRegulatoryNegative