Dual-chamber ICD launches worldwide, firm announces Nov. 8. Automatic device is approximately 20% smaller than nearest competitor, Guidant notes. FDA approved the device via PMA supplement on Aug. 8 (1"The Gray Sheet" Aug. 14, 2000, p. 9). Separately, the firm's Multi-Link Pixel coronary stent receives a CE mark Nov. 7. Lesion-specific device is designed to treat first-time blockages in native coronary arteries and saphenous vein bypass grafts with diameters less than 3.0 mm. Guidant plans to apply for FDA approval of the system in the second half of 2001 following completion of 150-patient U.S. clinical trial. Also in the stent area, the company reports the launch of the 30-patient SSYLVIA trial for treatment of cerebral atherosclerosis
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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 National Advertising Division (NAD) alerted Agendia to improve disclosure regarding a physician endorsing its MammaPrint test. The physician's ties to Agendia were inadequately revealed in LinkedIn posts.
Just a year and four months after publishing a final rule that would have allowed it to regulate laboratory developed tests as medical devices, the US FDA has rescinded the controversial measure, finally putting an end to the saga.
Exact Sciences has entered into an exclusive licensing agreement with Freenome, stipulating clinical benchmarks and a first-line rating in the USPSTF guidelines. Medtech Insight interviewed screening CMO Paul Limburg about CRC screening and Exact’s strategy on liquid biopsy.
