Point-of-care whole blood analyzer receives 510(k) clearance. The analyzer is used with a "reagent rotor" which includes test chemistries for glucose, aspartate aminotransferase, total bilirubin, uric acid and total protein. In early May, Abaxis will submit a 510(k) application for a "primary health-panel" reagent rotor containing 10-13 chemistries used in measuring general health. The Piccolo system, slated for a fall market launch to physician offices and hospitals, will sell for about $8,000, with the disposable reagent rotors priced between $8 and $12
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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 EU’s Artificial Intelligence Act, which entered into force on 1 August 2024, is already facing turbulence.
While HistoSonics is awaiting the CE mark in Europe, it hit a major milestone by securing early limited market access in Great Britain under a Unmet Clinical Need Authorization (UCNA), bringing its noninvasive histotripsy treatment to patients with liver tumors.
Manufacturing shifts, financial planning, and supply chain changes are among the adjustments that medtech leaders are making to Trump-era tariffs. Medtech Insight’s review of first-quarter earnings calls reveals how firms are navigating the impact and uncertainty of evolving trade policies.
