While no medical device start-up operates in a risk-free zone, CyberHeart is minimizing its risk by using core technology that is already proven in another therapeutic area, cancer. The start-up has licensed cardiac tissue ablation rights to Accuray Inc.'s CyberKnife robotic radiosurgery system, and intends to use it to develop a completely noninvasive approach for the large, unmet atrial fibrillation market.
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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.
Q’Apel Medical has pulled its aspiration system for stroke thrombectomy from the market after concerns raised by the US FDA in a February warning letter.
The FDA's final LDT ruling was struck down in federal court last month. For now, diagnostic companies can commercialize under CLIA regulations or apply for FDA approval. McDermott and Tribun Health have shared insights on the risks, pros and cons of both regulatory routes.
