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...
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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.
TRiCares presented data from the first-in-human study for its tricuspid valve replacement system – Topaz – at EuroPCR 2025 on 22 May.
The US’ 90-day suspension of higher “reciprocal tariffs” will expire on 9 July, raising fears that the 31% tariff rate on Swiss medtech and other goods exported to the US might make a comeback. While the tariff situation changes on an almost daily basis, medtechs should forearm for any eventually, say local business organizations.
Guardant Health introduces a new germline panel test to help guide cancer treatment, assess the risk of secondary cancers in patients and identify family members at risk of cancer.
