Medtronic Gains FDA and CE Mark Clearance for LINQ II

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Medtronic recently announced that it received clearance from the FDA and CE Mark approval for its LINQ II insertable cardiac monitor (ICM). The announcement notes that ICMs “are small, subcutaneously implanted devices offering continuous ambulatory electrocardiogram monitoring” and that in particular, ICMs focus on detecting and managing subclinical atrial fibrillation.  Articles have noted that recently some ICM’s have expanded their monitoring capabilities to assist with home monitoring of COVID-19 patients.

The LINQ II system purports to offer remote programming and remote patient management that allow system optimization without the patient visiting the hospital.  Rob Kowal, M.D. Ph.D, the chief medical officer of Medtronic’s Cardiac Rhythm and Heart Failure division touted this as an advantage of the LINQ II system in view of the COVID-19 environment:

[T]he LINQ II system offers patients a seamless way to experience ongoing connectivity between their device and their physician, while reducing the need for in-office visits.

Medtronic advertises the LINQ II as delivering the lowest published rate of false positives as compared to other ICM devices.  Medtronic asserts that this increased accuracy will allow clinicians to spend approximately 33% less time reviewing ICM transmission, thereby streamlining their workflows.  The LINQ II also purports to offer up to a 4.5 year lifespan, a 50% increase from the three year average lifespan of ICM’s reported in 2018.  According to Medtronic, the LINQ II system also includes Medtronic’s MyCareLink Heart mobile app to automatically transfer data from the LINQ II to their physician.  For patients who cannot use a cell phone, Medtronic notes that it offers a dedicated MyCareLink Relay Home Communicator.

Brandon Smith
Brandon Smith is an associate in our Orange County office. His practice is focused on patent litigation and prosecution. Mr. Smith earned his Bachelor's of Science in Biomedical Engineering at California Polytechnic University, San Luis Obispo. Mr. Smith received his J.D. from the University of San Diego School of Law where he was Editor-in-Chief of Volume 52 of the San Diego Law Review. Mr. Smith was a summer associate with the firm in 2014 and joined the firm as an associate in 2015.
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