FDA Updates Breakthrough Device Guidance - Healthcare
On September 15, 2023, FDA published an update to the guidance document – "Breakthrough Devices Program, Guidance for Industry and Food and Drug Administration Staff."
Source: mondaq.com
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First Patient with NyokAssist™ Interventional Ventricular Assist Device: Dr. Junbo Ge's team successfully completed the first high-risk PCI treatment supported by the new generation of interventional VAD
/PRNewswire/ -- Recently, NyokAssist™ was first-in-man (FIM) use, supporting High-risk PCI completed by Dr. Junbo Ge's team from Zhongshan Hospital in Shanghai....
Source: prnewswire.com
magAssist's NyokAssist™️ granted Designation by the FDA as a Breakthrough Device
/PRNewswire/ -- Recently, magAssist's NyokAssist™ Interventional Ventricular Assist Device (hereinafter referred to as NyokAssist™), has been granted...
Source: prnewswire.com
AVITA Medical, Inc. (NASDAQ:RCEL) Q2 2023 Earnings Call Transcript
AVITA Medical, Inc. (NASDAQ:RCEL) Q2 2023 Earnings Call Transcript August 10, 2023 AVITA Medical, Inc. misses on earnings expectations. Reported EPS is $-0.41 EPS, expectations were $-0.34. Operator: Good day and thank you for standing by. Welcome to the AVITA Medical Inc. Second Quarter 2023 Earnings Call. At this time all participants are in a […]
Source: yahoo.com
GIE Medical Granted FDA's Breakthrough Device Designation for Multi-Stage Drug Coated Balloon to Treat Esophageal Strictures
/PRNewswire/ -- GIE Medical, a clinical stage company developing solutions for patients suffering from benign stricture(s) of the esophagus or bowel, was...
Source: prnewswire.com