Context: The United States International Trade Commission (ITC) has become an increasingly popular venue for pharmaceutical and medical device patent enforcement. Data on the ITC’s website revealed last month that 8% of Section 337 complaints are related to drugs and medical devices, second only to those related to computer and telecommunications products (42%) (June 19, 2025 ip fray article). California-based Ceribell develops electroencephalography (EEG) technology, used in devices to detect electrographic seizures. In April, it became the first company to receive FDA approval for an AI-powered algorithm that can detect such seizures in patients from age one up (April 15, 2025 Ceribell press release).
What’s new: Ceribell has filed an ITC complaint against Natus Medical and its subsidiary Excel Tech, alleging that they have infringed six EEG-related patents. It is seeking an import ban against the companies’ allegedly infringing products, and has also sued the companies in the District of Delaware over the same six patents.
Direct impact and wider ramifications: This is not the first time Natus has been sued for patent infringement. In 2015, Nox Medical sued the company for infringing patents related to neurological sleep diagnostic technology, seeking an injunction and damages. In April 2018, the District of Delaware sided with Nox Medical, granting it a permanent injunction. The company did not appear to appeal that decision, indicating that Natus “is an adjudicated copyist in the industry”, Ceribell has alleged.
Ceribell focuses on the development of devices used to diagnose and manage patients with serious neurological conditions. In 2017, the FDA approved Ceribell System, which is used to detect seizure activities in intensive care units and emergency rooms across the U.S.
Natus Medical is a medical device manufacturer that specializes in the detection of disorders affecting the brain. In 2022, Natus was acquired by private equity firm ArchiMed. Its subsidiary Excel-Tech, which is based in Canada, manufactures the EEG recorder that is contained in the allegedly infringing product, Ceribell claims.
The manufacturers launched BrainWatch in May, an EEG platform for intensive care units, which Ceribell alleges infringes its EEG-related patents (May 20, 2025 Natus press release). Ceribell alleges that, despite having a history in the EEG domain that traces back to 1935, Natus “failed to meaningfully grow the market beyond $350 million… either because it lacked the vision to recognize the significant shortcomings of its products in serving ICU and ED patients, or because it had no incentive to disrupt what had been a consistent and status quo-driven business”.
Until BrainWatch, Ceribell claims, Natus had never marketed a wearable, point-of-care EEG system.
In a statement yesterday, Ceribell’s CEO and co-founder, Xingjuan (Jane) Chao, said:
“From clinical research to continuous product advancements, Ceribell has made significant investments in point-of-care EEG technology. Ceribell deeply values the innovations we bring to the healthcare community and is committed to fair competition. We will vigorously protect our intellectual property against infringement so that we can continue to deliver leading-edge products to healthcare professionals and their patients.”
Four of the patents-in-suit are entitled “Methods and apparatus for electrode placement and tracking”:
- U.S. Patent No. 9,820,670
- U.S. Patent No. 12,150,769
- U.S. Patent No. 12,324,670
- U.S. Patent No. 12,336,826
The remaining two patents are entitled “Adjustable geometry wearable electrodes”:
Ceribell’s allegations
Ceribell’s 77-page ITC complaint claims that Natus and Excel-Tech are “serial copycats”. Rather than innovate, they “systematically steal”, it has alleged. After a federal jury found in 2018 that Natus had willfully infringed another company’s patents on neurological sleep diagnostic technology, the company has “struck again”, it said.
In December 2024, Natus received FDA clearance for its BrainWatch technology, expressly naming both the Ceribell Pocket EEG Device and Ceribell Instant EEG Headband as predicate devices (December 12, 2024 Practical Neurology article). Natus compared the devices to those owned by Ceribell in a table attached to the clearance summary, noting that any differences between these devices “are minor and do not impact the overall performance or safety”, Ceribell noted.
Even though Natus has the resources and experience to develop point-of-care EEG products, it was Ceribell that “revolutionized” the industry, proving the existence of an estimated $2 billion opportunity in the U.S. alone, it has claimed. Natus now seeks to exploit this by “piggybacking” on Ceribell’s efforts, it said.
The medical tech manufacturer has even gone as far as to say that its technology and “very existence” are a direct reflection of “Natus’ inability or failure to innovate”.
Counsel
Ceribell is being represented by a team at Quinn Emanuel Urquhart & Sullivan LLP: S. Alex Lasher, Brian L. Saunders, Kevin P.B. Johnson, Victoria F. Maroulis, Andrew J. Bramhall, and Margaret Shyr.