Electro-shock comments: FDA will accept public comments through Jan. 8 on electro-shock therapy devices in response to a "significant number of inquiries from members of the public and the health care community," the agency says. Electroconvulsive therapy systems are among the 27 device types available prior to the 1976 Medical Device Amendments, for which new versions can reach the market via 510(k) clearance, though they have not been formally risk-classified by FDA. The agency ordered makers of ECT devices and 24 other product types to submit safety and effectiveness information by Aug. 7 to inform FDA's decision on whether to down-classify the products to Class I or II, or require PMA applications (1"The Gray Sheet" Aug. 17, 2009). The new docket allows individuals other than manufacturers to submit information on the safety and efficacy of ECT devices. FDA did not specify the source of the inquiries leading to the comment opening, but there has been substantial debate among the psychiatric establishment, which generally supports 510(k) access for ECT devices, and skeptic groups, such as the Committee on Truth in Psychiatry, an organization of former shock therapy patients who push for more substantial regulation
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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.
During MD&M East last week, regulatory consultant Darren Reeves reminded device manufacturers that the time to get ready to comply with the new Quality Management System Regulation is now.
Handheld diagnostics are more powerful, accessible and clinically relevant than ever. Medtech Insight spoke to companies behind such technologies to learn how they work and discuss their commercial models.
An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.
