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AACC 2020: COVID-19 Paved Way For ‘Retailization,’ Innovation In Point-Of-Care Testing, Now What?

 
• By Marion Webb

A panel discussed opportunities and challenges in POC testing beyond the pandemic, including the consumer-centric health care environment and continued innovation.

Corona Test

The pandemic has ushered in a new era in point-of-care (POC) testing in which technologies are increasingly becoming more accessible, more affordable and more convenient, putting the consumers’ needs first.

A panel of experts at the recent American Association for Clinical Chemistry meeting, which focused on disruptive technologies in POC...

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With LDT Rule DOA, Could FDA Shift Focus To RUOs?

 
• By Brian Bossetta

Now that the US FDA has chosen not to appeal a March ruling effectively killing the agency’s efforts to regulate lab-developed tests as medical devices, will the agency adopt a different strategy to flex its regulatory muscle?

Aneira Health Launches New Precision Medicine Platform Exclusively For Women

 
• By Natasha Barrow

Cecilia Lindgren, Aneira Health’s co-founder and chief science officer, said that the company has “redesigned the diagnostic model.” The subscription-based platform offers clinical-grade and AI diagnostics alongside clinical consultation.

Guardant’s Multi-Cancer Detection Test Granted FDA Breakthrough Device Designation

 
• By Natasha Barrow

Guardant Health’s methylation-based blood test – Shield MCD – showed a specificity of 98.6% and sensitivity of 75% across eight cancer types in its clinical validation data presented at ASCO.

Final Curtain For LDTs? FDA Will Not Appeal District Court Decision To Vacate Final Rule

 
• By Brian Bossetta

The US FDA has given up on its effort to regulate lab-developed tests as medical devices, at least for now. The agency will not appeal a decision from the Eastern District of Texas that tossed out the FDA’s final rule, leaving the agency with few cards.

More from Diagnostics

Digital Health Roundup: Synchron Syncs With Apple, Ketryx’s AI Agents, AdvaMed’s AI RoadMap

 
• By Marion Webb, Brian Bossetta, Natasha Barrow, Elizabeth Orr, and Shubham Singh

In this week's Digital Health Roundup, MedTech Insight's Shubham Singh explores how Ketryx's launch of validated AI agents could reshape compliance automation in medtech. Marion Webb highlights news from BCI makers Synchron, Axoft and Subsense. Elizabeth Orr discusses AI advances at the FDA.

Guardant’s Multi-Cancer Detection Test Granted FDA Breakthrough Device Designation

 
• By Natasha Barrow

Guardant Health’s methylation-based blood test – Shield MCD – showed a specificity of 98.6% and sensitivity of 75% across eight cancer types in its clinical validation data presented at ASCO.

GE HealthCare Announces US Launch Of Longer Half-Life PET MPI Agent For Ischemia Detection

 
• By Shubham Singh

GE HealthCare is pursuing a dual-front imaging strategy with its PET MIP agent Flyrcado for detecting artery disease: It lasts longer than current PET scan tracers and allows patients to do treadmill-based stress tests alongside the scan.