Marketing plans for the Roche instrument, currently regulated as an analyte-specific reagent, have not changed at this time, though the company continues to hold discussions with FDA in the wake of a 1July letter from Office of In Vitro Diagnostic Devices Director Steve Gutman. OIVD cited public statements from Roche suggesting that the microarray is "an assembled device that is part of a specific test system," which, according to Gutman, would imply that AmpliChip is inaccurately classified, and may be subject to stricter regulation (2"The Gray Sheet" July 14, 2003, p. 20). Roche Molecular Diagnostics, based in Pleasanton, Calif., met with FDA the week of July 21 and has had several teleconferences with the agency over the microarray, developed under an agreement with Affymetrix...
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.
BioWales in London 2025 showcased the efforts healthtech innovators are making to meet investors on their own turf, illustrating changing attitudes and evolving needs.
Ahead of the 11 June UK spending review and its anticipated funding uplift for healthcare and life sciences, the MHRA announced an expansion of its digital expertise by creating a dedicated hub in Leeds, a renowned center of medtech excellence.
The $10m seed extension funding round will be used to launch the second-generation wearable headband with the added SmartSleep AI operating system.
