Elizabeth Orr

3 days ago | insights.citeline.com | Marion Webb |Brian Bossetta |Natasha Barrow |Elizabeth Orr

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

1 week ago | insights.citeline.com | Elizabeth Orr

Zika Virus Test Among 4 New FDA Device ClassificationsThe FDA plans to announce class II status for four new device types, including tests for the Zika virus and genetic condition Fragile X. This follows earlier announcements and highlights a trend toward diagnostic classifications. The classifications are considered deregulatory, meaning they will hel(Jarun Ontakrai/Shutterstock)

2 weeks ago | insights.citeline.com | Elizabeth Orr

FDA Halts Acceptance Of Chinese Lab Data Due To Accuracy IssuesThe FDA has stopped accepting data from two Chinese labs due to accuracy issues. Mid-Link and SDWH have been flagged for potentially falsified results and other misconduct. This decision, which follows months of discussions and warnings, emphasizes the FDA's commitment to ensuring data integrity in medical device submissions.

2 weeks ago | insights.citeline.com | Elizabeth Orr

FDLI: Clinical Labs Face Uncertainty After Texas Court’s LDT RulingA Texas court's decision against US FDA regulation of lab-developed tests (LDTs) has introduced new uncertainties for clinical labs. Industry stakeholders are now worried about potential future regulations while also managing existing compliance requirements. Recent conference discussions underscored the complexities of FDA oversight. (Andrey Popov/Shutterstock)

2 weeks ago | insights.citeline.com | Elizabeth Orr

Debate On FDA User Fee Reauthorization Begins To Take ShapeA battle may be forming over the 2027 FDA user fee reauthorizations. At a conference Friday, Democratic Rep. Jake Auchincloss supports them for their effectiveness, while Deputy FDA Commissioner Grace Graham echoed criticisms from HHS Sec. Kennedy, among others, in calling for reform to ensure public trust. Rep. Jake Auchincloss, D-MA, pictured in front of the Capitol building in 2024.