NeoPath AutoPap: Premarket approval application supplement supporting use of the automated cytology sample analyzer as a primary screening tool is tentatively set for review by FDA's Hematology and Pathology Devices Panel at its September 27, 1996 meeting, NeoPath says. The AutoPap was approved by FDA in September 1995 for use in quality control rescreening of Pap smear samples ("The Gray Sheet" Oct. 9, 1995, p. 6). The PMA supplement was accepted for filing by FDA in early June...
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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.
An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.
In revising the foundations of EU product legislation, the European Commission aims to increase harmonization, cut regulatory burdens and promote digital tools to boost compliance and safety.
The medtech M&A landscape is experiencing a resurgence fueled by significant capital from private equity and venture firms, says Alex Wakefield, CRO of AcuityMD. Building strong relationships with physicians remains crucial in medtech, and defining an exit strategy early is imperative.
