The final submission deadline for medical device companies wishing to keep their products on the Malaysian market as the country transitions to a conformity assessment-based system is approaching fast.
The final submission deadline for medical device companies wishing to keep their products on the Malaysian market as the country transitions to a conformity assessment-based system is approaching fast.
June 30 2015 is the last date by which applicants must file with the Malaysian MDA. This deadline was set...
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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.
During a recent FDLI panel, experts discussed the FDA's Home Healthcare initiative, highlighting its potential benefits and challenges. Key issues include usability testing, reimbursement, labeling for home use, and the need for innovation while ensuring patient safety.
An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.
The EU’s Artificial Intelligence Act, which entered into force on 1 August 2024, is already facing turbulence.
