Johnson & Johnson subsidiary Alza will launch in 2007 its Ionsys needle-free, patient-activated iontophoresis transdermal fentanyl drug delivery system for post-operative pain, the firm says. FDA approved the system May 22 for short-term management of post-operative pain in adults requiring opioid analgesia during hospitalization. Ionsys' E-Trans delivery technology uses low-intensity electrical current to move a 40 mcg dose of fentanyl from a reservoir into the skin over a 10-minute period. Alza also markets the controlled-release fentanyl patch Duragesic. The road to approval for Ionsys has been relatively long. A September 2003 NDA filing was deemed "approvable" in July 2004. The company resubmitted the application in November 2005...
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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.
A Japanese study of Watchman LAA closure devices found that leaks of any size after implantation raise the risk of stroke. The study comes shortly after the US FDA issued an early alert for the Watchman access systems.
A late-August batch of device classifications from the US FDA includes genetic tests from 23andMe, hand-held spinal surgery tools, and several IVDs.
Amendments to Germany’s – barely in force – health reform law will be decided after the summer break. The new DRGs payments plan and service groups will be reviewed, but critics fear for the law’s future.
