Page 6 - Breakthrough Device News Today

In a significant advancement for cancer therapy, the Food and Drug Administration (FDA) has awarded RadioGel Precision Radionuclide Therapy the coveted Breakthrough Device Designation.

In a significant advancement for cancer therapy, the Food and Drug Administration (FDA) has awarded RadioGel Precision Radionuclide Therapy the coveted…

Richland WA, Dec. 20, 2023 -- Vivos Inc. , Vivos Inc is pleased to announce that the Food and Drug Administration has granted RadioGel Precision Radionuclide Therapy the designation as a...

Analyst Hosted Event to Feature Comprehensive Discussion of Envoy Medical’s Products, Interviews with Two Study Investigators and Key Opinion Leaders in Cochlear Implants WHITE BEAR LAKE,...

Aethlon Medical (NASDAQ: AEMD) Research/Media Alert: Expect Focus on Oncology Studies; Cost Containment Efforts

/PRNewswire/ -- Earlier this month, magAssist Co.,Ltd. ("magAssist" and "the Company"), a leading medical developer of extracorporeal life support devices in...

Acrivon Therapeutics, Inc. (ACRV) announced the FDA has granted Breakthrough Device designation for the ACR-368 OncoSignature assay, a multiplex immunofluorescence assay for the identification of ovarian cancer patients who may benefit from ACR-368 treatment.

AWAK Technologies (AWAK), a pioneering medical technology company developing a wearable dialysis product and other complementary solutions for chronic kidney disease (CKD) management, today announced that its kidney disease progression prediction (KDPP) Artificial Intelligence (AI) model for CKD patient care has been granted Breakthrough Device designation by the U.S. Food and Drug Administration (FDA). The KDPP model helps to assess the risk of kidney disease progression and initiation of renal

NeuroEM Therapeutics Emerges from Chapter 11 with a Stronger Vision, ...

An Auckland medtech startup has won a rare spot on a programme that fast-tracks devices for regulatory approval in the US. Toku Eyes makes AI-powered...