Yahoo Finance13d
FDA grants breakthrough designation to PreludeDx’s DCIS test
The US Food and Drug Administration (FDA) has granted breakthrough device designation to PreludeDx's DCISionRT test, a risk assessment tool for ductal carcinoma in situ (DCIS), also known as Stage ...
Morningstar9d
IntelliGenome Receives FDA Breakthrough Device Designation for CRISPR-TB Blood Test
"The FDA's Breakthrough Device Designation for our CRISPR-TB Blood Test is a significant milestone for IntelliGenome. This recognition highlights our commitment to advancing innovative, accessible ...
Healio9d
Bluejay Therapeutics’ brelovitug secures FDA breakthrough status for chronic HDV
Please provide your email address to receive an email when new articles are posted on . The FDA has granted breakthrough therapy designation to Bluejay Therapeutics’ brelovitug for the treatment ...
Business Insider22d
Rezolute Gains FDA Breakthrough Designation for Ersodetug
Rezolute, Inc. announced that the FDA has granted Breakthrough Therapy Designation to its drug, ersodetug, for treating hypoglycemia caused by congenital hyperinsulinism. This designation ...
SiliconRepublic10d
CergenX making Waves with new FDA designation
Now, with its latest achievements, CergenX plans to collaborate with the FDA throughout the Wave device’s development and premarket review. “Receiving the Breakthrough Device Designation and ...
The Victoria Advocate14d
PreludeDx Receives FDA Breakthrough Device Designation for DCISionRT® Test for DCIS Breast Cancer Patients
announced today that the U.S. Food and Drug Administration (FDA) granted Breakthrough Device designation for its DCISionRT® test. DCISionRT provides individualized risk assessment and predicts ...
medtechdive9d
Irish Neurotech Start-up, CergenX Receives FDA Breakthrough Designation for Wave Device
A CergenX-led consortium, including UCC/ INFANT, was awarded €6.7 million in funding from The Disruptive Technologies ...
Business Insider23d
Rezolute Receives Breakthrough Therapy Designation from FDA for Ersodetug in the Treatment of Hypoglycemia Due to Congenital Hyperinsulinism
These forward-looking statements include but are not limited to statements regarding the FDA’s grant of the Breakthrough Therapy Designation for ersodetug, the ersodetug Expanded Access Program ...
Business Wire23d
AccurKardia Receives FDA Breakthrough Device Designation for AI-powered Hyperkalemia Detection Solution Using Lead I ECG Data
NEW YORK--(BUSINESS WIRE)--AccurKardia, an innovator in ECG-based diagnostics technology, has announced that it has received Breakthrough Device Designation by the U.S. Food and Drug ...