Latest news and insights on the pharmaceutical industry | Indian Pharma Post

Results For "FDA-Breakthrough-Device"

10 News Found

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


Roche's Elecsys Amyloid Plasma Panel granted FDA breakthrough device designation to enable a timely diagnosis of Alzheimer’s disease
News | July 20, 2022

Roche's Elecsys Amyloid Plasma Panel granted FDA breakthrough device designation to enable a timely diagnosis of Alzheimer’s disease

The Elecsys Amyloid Plasma Panel has the potential to ensure better identification of patients that require further confirmatory testing, supporting a more timely and accessible diagnosis.


Laguna Diagnostics secures FDA breakthrough tag for mRNA test in psychiatric diagnosis
Healthcare | April 29, 2026

Laguna Diagnostics secures FDA breakthrough tag for mRNA test in psychiatric diagnosis

The company receives approval for blood-based test enabling objective differentiation of schizophrenia and bipolar disorder


Mosaic Clinical Technologies’ AI breakthrough earns FDA “Breakthrough Device” designation
Medical Device | March 10, 2026

Mosaic Clinical Technologies’ AI breakthrough earns FDA “Breakthrough Device” designation

Cognita CXR leverages a proprietary vision-language model to analyze full chest X-ray studies and generate comprehensive preliminary findings


Alphatec and Theradaptive forge landmark spine partnership as Series B round launches
News | January 16, 2026

Alphatec and Theradaptive forge landmark spine partnership as Series B round launches

ATEC secures exclusive U.S. commercial rights to Theradaptive’s OsteoAdapt osteoinductive bone graft, currently in clinical trials for spinal and dental applications


Investors pile in as Cordance secures oversubscribed seed round for brain-cancer tech
News | November 27, 2025

Investors pile in as Cordance secures oversubscribed seed round for brain-cancer tech

The fresh capital will propel Cordance into its first-in-human clinical trial


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


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


Amber Implants VCFix spinal system receives breakthrough designation
Healthcare | October 05, 2021

Amber Implants VCFix spinal system receives breakthrough designation

The first clinical trial is expected to commence in early 2022 both in Europe and the US


Tesis Labs and Personal Genome Diagnostics tie-up to advance cancer treatment
Digitisation | August 11, 2021

Tesis Labs and Personal Genome Diagnostics tie-up to advance cancer treatment

The aim is to create new genomics solutions that could combat cancer and advance market access