Neopath's Autopap: Pap smear analysis product as a primary screening device will be reviewed by FDA's Hematology and Pathology Devices Panel on Jan. 28, the company reports. The PMA supplement would allow use of the Autopap to identify certain slides as not requiring a manual evaluation. Following the advisory panel's initial rejection of the supplement in September 1996, Neopath amended the application in August with prospective data from about 31,500 slides. The data show the system to be statistically "superior" to current practice in identifying a range of atypical Pap smears, according to the company. The Autopap currently is approved as a quality control rescreener of slides identified by technicians as negative...
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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.
FDA moves forward with implementing previous draft guidance and will consolidate forms, but the agency estimates limited impact in the total reporting burden.
Ultrahuman seeks to “create an environment that aligns with our bodies" by linking environmental parameters collected by Ultrahuman Home to health physiology, measured by the Ultrahuman Ring Air.
The US FDA's new draft guidance details the responsibilities of new owners of 510(k) clearances, including making timely updates device listings in FURLS and GUDID to maintain accurate information for safety alerts and recalls. Comments on the draft are accepted until 4 August.
