Definitive stock-swap merger agreement valued at over $50 mil. would combine San Diego-based Novex, a supplier of pre-cast electrophoresis gels and related instruments, with Invitrogen, maker of research tool kits for gene cloning and protein expression, also based in San Diego. Combined annual revenues would exceed $50 mil. Invitrogen revenues were $31.4 mil. in 1998; net income was $3 mil. Novex generated revenues of $23.1 mil. for the fiscal year ended March 31, and net income of $1.1 mil. Acquisition of Novex is part of Invitrogen's strategy "to expand our leadership in providing products that accelerate gene discovery and analysis," the firm says
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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.
The US FDA has updated its guidance document on small business eligibility determinations for medical device firms. Industry observers urge companies to ask for the status early to avoid any potential hold-ups.
Pending legislation seeks to address what the sponsors argue is a lack of transparency in medical billing. If enacted, the bill would provide patients with the costs of procedures and medications before receiving them. A data collection expert discusses what the bill could mean for patients.
Notified bodies are calling for their key role, as the technical, regulatory and clinical ‘extended arm’ of regulatory authorities, to remain central to the EU medtech conformity assessment process.
