FDA'S ACCREDITED PERSONS (AP) INSPECTION PROGRAM IS STRUGGLING because of financial costs to manufacturers, difficulties in getting third-party auditors trained and industry apathy, experts say. Since it was created in 2003, only about 90 inspections have been completed under the program, which allows manufacturers to hire agency-approved auditors to conduct FDA quality system inspections. "It would be very helpful if industry really embraced the program, but the bottom line is that industry is not embracing it," David Kalins, CDRH's AP program coordinator says. Two of the 16 auditing firms certified by the agency to perform AP inspections - Underwriters Laboratories and TUV SÜD America - talk about the challenges they face. Meanwhile, an updated FDA guidance on the AP program explains statutory changes made in 2007 that make it easier for firms to take part
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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.
Speakers at a recent UK medtech outlook conference voiced optimism about the sector’s prospects, but warned that cost burdens, over-regulation and lengthy processes will impede the capacity of local SMEs to innovate. Only 10% of NHS procured medtech comes from UK manufacturers.
Roche aims to grow its diagnostics sales by mid to high single digits, said CEO of Roche Diagnostics Matt Sause. The company unveiled the Axelios synthesis and sequencing solution and discussed its “long-term commitment” to China, as well as its business strategy for the next five years.
