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Results For "Breakthrough-Device-Designation"

23 News Found

Quest Diagnostics reports strong third quarter 2025 results and raises full-year guidance
News | October 25, 2025

Quest Diagnostics reports strong third quarter 2025 results and raises full-year guidance

Revenues up 13.1% year-over-year; Continued momentum driven by organic growth, strategic partnerships, and acquisitions


FDA authorizes first eyeglass lenses to slow progression of pediatric Myopia
News | September 30, 2025

FDA authorizes first eyeglass lenses to slow progression of pediatric Myopia

FDA authorization was based on two years of clinical study data demonstrating that Essilor Stellest lenses significantly slowed myopia progression compared to single-vision control lenses


Roche presents new Alzheimer’s research at AAIC 2025
Clinical Trials | July 31, 2025

Roche presents new Alzheimer’s research at AAIC 2025

Roche also shared the design of its upcoming Phase III TRONTIER 1 and 2 trials investigating trontinemab in people with early symptomatic Alzheimer’s disease


Qure.ai adds new FDA breakthrough device status for qSpot-TB
Digitisation | February 09, 2024

Qure.ai adds new FDA breakthrough device status for qSpot-TB

4 FDA clearances & 61 EU MDR CE tags achieved for AI in 18 months


Synchron raises $75 mn Series C Led by ARCH Venture Partners
News | December 16, 2022

Synchron raises $75 mn Series C Led by ARCH Venture Partners

Gates Frontier, Bezos Expeditions, Reliance Digital Health Limited, Greenoaks, Alumni Ventures, Moore Strategic Ventures, and Project X join ARCH as new additional investors


Biological Dynamics study demonstrates detection of early-stage cancers
Biotech | March 21, 2022

Biological Dynamics study demonstrates detection of early-stage cancers

In a Nature Communications Medicine publication, the Verita proprietary platform detected 96 per cent of stage 1 pancreatic cancers and three-quarters of stage 1 ovarian cancers using isolated exosomes and AI-enabled protein marker analysis


Europe clears blood test to predict Alzheimer’s disease
Medical Device | February 28, 2022

Europe clears blood test to predict Alzheimer’s disease

It is the first approved blood test that can predict likely progression to Alzheimer's Disease up to six years in advance


USFDA grants Breakthrough Designation for Datar’s early-stage prostate cancer detection blood test
Healthcare | February 15, 2022

USFDA grants Breakthrough Designation for Datar’s early-stage prostate cancer detection blood test

Last year, the company's early-stage breast cancer detection test became the first such test to receive the Breakthrough Device Designation


U.S. FDA grants De Novo Clearance for Philips IVC filter removal laser sheath
Medical Device | December 23, 2021

U.S. FDA grants De Novo Clearance for Philips IVC filter removal laser sheath

Philips’s CavaClear is intended to safely ablate tissue to remove embedded IVC filters


U.S. FDA grants breakthrough designation to Datar’s blood test to detect breast cancer
Drug Approval | November 20, 2021

U.S. FDA grants breakthrough designation to Datar’s blood test to detect breast cancer

It is the first blood test able to detect early-stage Breast Cancer with high accuracy in women above the age of 40 years