"Bone void filler devices composed of alternate materials may be demonstrated to be substantially equivalent...to the resobable calcium salt bone void filler device identified in this guidance," FDA notes in its 1Class II special controls guidance on bone void fillers. However, FDA cautions that the guidance addresses only submission requirements and risk mitigation measures for resorbable calcium salt intended to fill bony gaps not intrinsic to the stability of the bony structure. Posted on the CDRH website May 28, the final guidance supersedes a Feb. 7, 2002 draft issued following a petition to reclassify Wright Medical Technologies' Osteoset into Class II (2"The Gray Sheet" Feb. 11, 2002, p. 11)...
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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.
TRiCares presented data from the first-in-human study for its tricuspid valve replacement system – Topaz – at EuroPCR 2025 on 22 May.
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.
