Breakthrough Device Program News Today

This designation assures enhanced FDA cooperation and priority regulatory review of the company's novel medical solution for back pain due to degenerative disc diseaseOXFORD, England--(BUSINESS WIRE)--ORTHOSON, a medtech innovator developing a portfolio of novel treatments for back pain, today announced that its Bio...

Swedish medical device startup Acorai is pairing proprietary sensing hardware and machine learning software with the goal of putting a non-invasive heart pressure monitoring tool in the hands of clinicians -- starting with doctors in the U.S. Patients hospitalized with heart failure typically need to undergo an invasive procedure, such as catheterization or having an implant, in order for their medical team to gain information on the pressures inside the chambers of their heart to support their...

Medical device startup Acorai is pairing proprietary sensing hardware and machine learning software with the goal of putting a non-invasive heart pressure monitoring tool in the hands of clinicians.

ABK Biomedical successfully secured Breakthrough Device Designation from the FDA on December 5, 2023, for its Eye90 microspheres device, which is indicated for the treatment of...

Give new parents the Christmas gift they really want -- the Snoo promises up to three hours of extra sleep.

On September 15, 2023, FDA published an update to the guidance document – "Breakthrough Devices Program, Guidance for Industry and Food and Drug Administration Staff."

/PRNewswire/ -- Recently, NyokAssist™ was first-in-man (FIM) use, supporting High-risk PCI completed by Dr. Junbo Ges team from Zhongshan Hospital in Shanghai....

/PRNewswire/ -- Recently, magAssists NyokAssist™ Interventional Ventricular Assist Device (hereinafter referred to as NyokAssist™), has been granted...

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 […]

/PRNewswire/ -- GIE Medical, a clinical stage company developing solutions for patients suffering from benign stricture(s) of the esophagus or bowel, was...