Affymetrix grants Johnson & Johnson/Veridex non-exclusive access to its GeneChip System 3000Dx technology to develop and market in vitro cancer diagnostics, the firm announces Dec. 28. Five days earlier, FDA cleared Roche Molecular Systems' AmpliChip cytochrome P450 genotyping test for use with GeneChip to assess drug metabolism. According to the agency's Dec. 23 release, which hails AmpliChip as "the first DNA microarray test to be cleared by FDA," the P450 enzyme affects optimum dosage for chemotherapy, antidepressants, anti-psychotics and beta-blockers, among other drugs. The test "should be used along with clinical evaluation and other tools to determine the best treatment options for patients," FDA stipulates. Roche was requested to submit a 510(k) application for the test after FDA faulted the company for promoting the product, originally an analyte-specific reagent, as a stand-alone diagnostic (1"The Gray Sheet" July 14, 2003, p. 20)...
Join thousands of industry professionals who rely on Medtech Insight for daily insights
Already a subscriber?
Editor’s note: This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.
Editor’s note: We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, content format or the method in which you receive and access Medtech Insight, or if you love it how it is, now is the time to have your voice heard.
Medtronic announced it received expanded MRI labeling for its DBS systems, which is critical, given that almost 70% of all DBS-eligible patients will likely need an MRI at some point in their care, says Ashwini Sharan, CMO for Medtronic Neuromodulation.
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.
Cardiosense has launched a nationwide clinical study, SEISMIC-HF II, to validate its non-invasive, AI-powered technology for monitoring heart failure. The data will be used to file for US regulatory clearance of the Cardiosense heart failure monitoring platform.
Valued at over $1.9bn, ConcertAI is building on its pre-existing multi-agentic AI SaaS solution CARAai to bring life science customers the new Precision suite of applications: Precision Explorer, Precision Trials, Precision GTM and Precision360.
Second submission window for joint scientific consultations on a procedure to help prepare for joint clinical assessments will open from 2 to 30 June 2025.
