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Roche gets FDA clearance for test of emerging cardiovascular disease risk
Lipoprotein(a) has long been recognized as a critical marker for people at risk of cardiovascular disease. However, the health care industry has lacked the tools to tackle the problem.
Newronika Receives Investigational Device Exemption (IDE) from FDA to Initiate U.S. Clinical Trial of Adaptive DBS System
Newronika, the developer of groundbreaking adaptive deep brain stimulation technology, is proud to announce the receipt of an Investigational Device Exemption ...
News Medical1d
Experimental drug shows promise in restoring memory in Alzheimer's model
A paradigm-shifting study from the Centre for Addiction and Mental Health (CAMH) shows an experimental drug, GL-II-73, has the potential to restore memory and cognitive function in a mouse model of ...
COUR Pharmaceuticals Secures FDA Clearance of IND Application for CNP-103 in Type 1 Diabetes
The Phase 1b/2a study will assess the safety of CNP-103 in adults (aged 18-35) and pediatrics (aged 12-17) who have Stage III or newly diagnosed (within the last 6 months) T1D as well as C-peptide ...
Hosted on MSN2d
EssilorLuxottica wins FDA clearance and EU approval for OTC audio glasses
EssilorLuxottica has received approval in the US and EU to market its Nuance audio glasses, a device that combines hearing ...
These smart glasses just got FDA clearance as OTC hearing aids.
I got to try out EssilorLuxottica’s Nuance Audio glasses last month at CES 2025. They look like normal glasses, but can amplify the voice of whoever you’re speaking to while also dampening noisy ...
United Therapeutics announces FDA clearance of UKidney NDA
United Therapeutics (UTHR) announced that the FDA has cleared its investigational new drug application to initiate a clinical study of the ...
EssilorLuxottica receives FDA clearance for its Nuance audio glasses
EssilorLuxottica said on Monday it received a green light from the U.S. Food and Drug Administration (FDA) for its ...
News Medical6d
AI software improves detection of congenital heart defects in prenatal ultrasounds
Congenital heart defects (abnormalities of the heart that are present at birth) are the most common type of birth defect and, according to the Centers for Disease Control and Prevention, about 1 in 4 ...
Wall Street Journal20d
FDA Allows Flavored Zyn Nicotine Pouches to Stay on the Market
This growth has brought controversy. Photo illustration: Alexander Hotz U.S. health officials cleared America’s most popular nicotine pouch to stay on the market, saying Zyn’s benefit as a ...
CBS News20d
How food brands and drugmakers are responding to FDA's ban of food dye Red 3
The FDA says that food companies will have until Jan. 15, 2027 to stop using the dye. Drugmakers will have an extra year, until January 2028, to comply with the change. Red 3, also known as ...
Roll Call20d
FDA authorizes first nicotine pouches
The FDA authorized the 20 Zyn products under a premarket tobacco product application process granted under a 2009 tobacco control law. Because Zyn includes nicotine, it must abide by the same ...