BioMimetic bone graft: External fixation supported by BioMimetic Therapeutics' Augment injectable bone graft (formerly branded as GEM OS2) leads to faster bone formation in closed distal radius wrist fractures than external fixation alone, results from a 21-patient pilot study show. The Tennessee company announced Oct. 29 that CT scans by an independent, blinded radiologist showed that 40% of Augment patients in the study had at least 25% bone-fill across the fracture gap three weeks after the procedure, compared to zero control patients. The company notes that the patients in the Augment-treated group were, on average, more osteoporotic (lower bone density) than the control group. As of Oct. 28, the firm had enrolled 314 patients at 34 sites in its North American pivotal trial of Augment in foot and ankle fractures; it expects to complete enrollment of the planned 396-patient trial by early 2009 (1"The Gray Sheet" Aug. 18, 2008, p. 17)
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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.
Dxcover sets up new Clinical Laboratory Improvement Amendments (CLIA) lab in Franklin, Tennessee.
EnsoData positions itself as device-agnostic and interoperable, with FDA-cleared software that can integrate with all major devices. CEO Mortara said this flexibility helps maximize patient reach by enabling both direct provider engagement and integration with device manufacturers.
After multiple warning letters and safety communications, the US FDA has decided to block the import of certain endoscopes from Olympus. In total, the agency’s action pertains to 58 device models manufactured by the Japanese firm used in urinary, respiratory, abdominal and pelvic procedures.
