Post-Gutman OIVD: Steve Gutman will leave FDA for academia at year-end after 17 years with the agency, including 14 years leading the device center's in vitro diagnostics oversight efforts. In 1993, Gutman took over the now-defunct clinical laboratory devices division in CDRH's Office of Device Evaluation. In 2002, he was the founding director of the Office of In Vitro Diagnostic Device Evaluation and Safety, which has jurisdiction over both pre-market and post-market activity for test kits. Product waivers under the Clinical Laboratory Improvement Amendments and regulation of analyte specific reagents were among hot-topic policy issues he addressed during his tenure. Moving forward policies on the oversight of genetic, genomic and pharmacogenomic tests has also been a major focus. Gutman's last working day at FDA will be Dec. 9. He will join the faculty at the University of Central Florida early next year and may also do some consulting, he says. Don St. Pierre, OIVD's associate director for policy and operations, will serve as acting director until a replacement is found
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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.
BD is accelerating transitions of product sourcing for China to avoid tariffs. Historically, products like Vacutainer were exported from Sumter, SC, to China, and Flush was shipped from Columbus, NE.
The 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
The US FDA says its updated draft guidance represents one of several steps the agency is taking to develop electronic submission templates for the medical device industry. The document introduces stakeholders to currently available resources for supporting their pre-subs to the agency.
