All Updates

All Updates

icon
Filter
FDA approval
Cue Health becomes first company to receive FDA De Novo authorization for at-home Covid test
Preventive Healthcare
Jun 8, 2023
This week:
M&A
N-able acquires Adlumin for USD 266 million to strengthen cybersecurity offerings
Next-gen Cybersecurity
Today
M&A
Bitsight acquires Cybersixgill for USD 115 million to enhance threat intelligence capabilities
Cyber Insurance
Today
M&A
Snowflake acquires Datavolo to enhance data integration capabilities for undisclosed sum
Generative AI Infrastructure
Today
M&A
Snowflake acquires Datavolo to enhance data integration capabilities for undisclosed sum
Data Infrastructure & Analytics
Today
Product updates
Microsoft launches Copilot Actions for workplace automation
Foundation Models
Yesterday
M&A
Almanac acquires Gro Intelligence's IP assets for undisclosed sum
Smart Farming
Yesterday
Partnerships
Aduro Clean Technologies partners with Zeton to build hydrochemolytic pilot plant
Waste Recovery & Management Tech
Yesterday
Funding
Oishii raises USD 16 million in Series B funding from Resilience Reserve
Vertical Farming
Yesterday
Management news
GrowUp Farms appoints Mike Hedges as CEO
Vertical Farming
Yesterday
M&A
Rise Up acquires Yunoo and expands LMS monetization capabilities
EdTech: Corporate Learning
Yesterday
Preventive Healthcare

Preventive Healthcare

Jun 8, 2023

Cue Health becomes first company to receive FDA De Novo authorization for at-home Covid test

FDA approval

  • Virtual diagnostic platform Cue Health has received De Novo authorization from the FDA for its Cue Covid-19 Molecular Test, making it the first FDA-authorized home-use Covid-19 test. De Novo authorization is a regulatory pathway provided by the FDA for the approval of new medical devices. It is used when the device does not have a legally marketed predicate device to which it can be compared.

  • The Cue Covid-19 Molecular Test provides rapid results and detects all known Covid-19 variants of concern. The test delivers results in 20 minutes to connected mobile smart devices and has an accuracy of 98%. It can be used at home or at point-of-care settings. The test integrates with mobile smart devices and is part of Cue Care, which offers personalized access to diagnostic tests and Telehealth consultations.

Contact us

Gain access to all industry hubs, market maps, research tools, and more
Get a demo
arrow
menuarrow

By using this site, you agree to allow SPEEDA Edge and our partners to use cookies for analytics and personalization. Visit our privacy policy for more information about our data collection practices.