Bellwether suit in the product liability class action against Boston Scientific/ Guidant stemming from Guidant implantable defibrillator recalls in 2006 will go to a jury trial. On June 12, the U.S. District Court of Minnesota denied Boston Scientific's motions to dismiss claims by a California ICD recipient that Guidant failed to appropriately disclose information about potential device malfunctions. "This case concerns the issues of whether, how, and to whom information was shared (and to whom it should have been shared) about a device with an alleged defect and the cause of that alleged defect," Judge Donovan Frank says in his ruling. According to Boston Scientific's first-quarter 2007 report filed in May with the Securities & Exchange Commission, the firm expects the Guidant recall class actions to eventually cost $732 million (1"The Gray Sheet" July 24, 2006, p. 10)...
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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’ 90-day suspension of higher “reciprocal tariffs” will expire on 9 July, raising fears that the 31% tariff rate on Swiss medtech and other goods exported to the US might make a comeback. While the tariff situation changes on an almost daily basis, medtechs should forearm for any eventually, say local business organizations.
Guardant Health introduces a new germline panel test to help guide cancer treatment, assess the risk of secondary cancers in patients and identify family members at risk of cancer.