May 21, 2021 | News, Regulatory
The U.S. Food and Drug Administration (FDA) has cleared Overjet’s AI Dental Assist product, marking it the first AI technology to enter the dental industry to aid dental hygienists and dentists in real time. The SaMD (Software as a Medical Device) will support...
May 6, 2021 | News, Regulatory
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the early detection of oral and throat cancer through their proprietary mRNA technology in combination with Viome’s next-gen AI platform. The first-of-its-kind tool...
Jan 14, 2021 | News, Regulatory
Medtronic announced today (1/14) the launch of its clinical trial enrollment of the innovative Adaptive DBS Algorithm for Personalized Therapy in Parkinson’s Disease (ADAPT-PD). The novel trial, which will take place across 12 research study sites in the US, Europe...
Dec 9, 2020 | News, Regulatory
ReGelTec, a medical device company out of Baltimore’s leading medical device HYDRAFIL, has received Breakthrough Designation from the U.S. Food and Drug Administration (FDA). The Breakthrough Device Program was created with intentions to expedite the...
Dec 3, 2020 | Medical Translation
In the face of global issues in the life sciences sector, cross-border communication and collaboration are more important than ever. To address this need, CSOFT co-organized the GBA-Health 2020 Panel Discussion on cross border opportunities and challenges in the life...
