Manufacturers of medical device data systems (MDDS) would no longer need to submit PMAs to FDA under a proposed federal rule, but they would become subject to the Quality System Regulation. The draft regulation, issued Feb. 8 by FDA, would change the classification for an MDDS - a device that sends data electronically to another medical device or an electronic health record - from Class III to Class I. A Class III device is typically a high-risk, life-sustaining product, while the Class I designation is for devices that present minimal chance of harm to the patient. FDA states in the proposed rule that the application of the QSR, "particularly the design control provisions, would significantly reduce the risk of errors from these devices.
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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 UK government’s blueprint to deliver an NHS "fit for the future" was released on July 3.
Former HHS-OIG attorney Rob DeConti emphasized the significance of data analytics and compliance in combating healthcare fraud, urging medical tech companies to adopt robust measures to prevent potential risks.
Two recent recalls from the US FDA involve three deaths linked to an issue with an Abiomed heart pump — as well as three serious injuries related to angiographic catheters from Cook Medical.
