Illumina’s MiSeqDx instrument and MiSeqDx Universal Kit, granted de novo approval, allow clinicians to “develop and validate sequencing of any part of a patient’s genome,” FDA says.
High-throughput, next-generation DNA sequencing (NGS) devices received their first regulatory clearances from FDA Nov. 19 when the agency granted de novo approvals to two nondisease-specific diagnostic platforms made by Illumina Inc.
Illumina’s MiSeqDxPlatform instrumentation and MiSeqDx Universal Kit 1.0 allow clinicians to “develop and validate sequencing of any part of a...
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In this episode, Medtech Insight reporter Natasha Barrow speaks to LungLife AI CEO Paul Pagano. Lung Life AI is a US-based AIM-listed medical technology company that has developed a liquid biopsy test for the early detection of lung cancer called Lung LB. Pagano runs through the highlights of Lung Life AI journey to date and its future ambition for a strategic partnership. He also provides advice to similar diagnostic companies seeking reimbursement andcompliance with the US FDA Lab Developed Test ruling.
Zimmer Biomet is preparing to introduce iodine-coated hip implants to international markets, offering joint replacement patients a new alternative intended to ward off infection. The company intends to broaden the platform’s reach into “knees, shoulders and other categories in due time.”
Medical device companies are increasingly using AI to improve regulatory affairs strategies but face barriers such as risk aversion, regulatory clarity and data governance issues. Experts suggest a design control approach and human oversight to ensure successful AI integration.
Abbott has initiated a medical device correction for about 3 million FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors in the US after internal testing detected a risk the device may produce inaccurate glucose readings.
