Device manufacturers looking to bolster the biocompatibility of their products can now turn to Healionics, a supplier of biomaterial scaffolds designed to improve the biointegration of percutaneous or fully implanted medical devices. The company's STAR technology is a synthetic, three-dimensional matrix, similar to a thin, porous sponge. Because this biomaterial has been precisely engineered with uniform pore sizes to the approximate size of a single cell, the company says that living tissue and new blood vessels actually grow and weave into these pores.
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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.
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.
BD is accelerating transitions of product sourcing for China to avoid tariffs. Historically, products like Vacutainer were exported from Sumter, SC, to China, and Flush was shipped from Columbus, NE.
The FDA plans to announce class II status for four new device types, including tests for the Zika virus and genetic condition Fragile X. This follows earlier announcements and highlights a trend toward diagnostic classifications. The classifications are considered deregulatory, meaning they will hel
