Naox Technologies SAS secured U.S. FDA 510(k) clearance for Naox Link, its in-ear electroencephalography (EEG) device for clinical use both at home and in health care settings. Naox Link is a pair of earbuds the company hopes will transform how the brain activity is monitored, helping diagnose and track a number of conditions affecting the brain.
The reach of the med-tech patent wars now includes devices for electroencephalography thanks to a complaint recently filed by Sunnyvale, Calif.-based Ceribell Inc. with the U.S. International Trade Commission. The company alleged infringement of six of its patents by two units under the Natus umbrella of companies, but this conflict is also under review in Delaware district court, promising a drawn-out conflict that may not resolve for years.
The U.S. FDA has granted de novo clearance for Epiminder Pty. Ltd.’s Minder implantable device for continuously monitoring brain activity in patients with epilepsy.
The first patenting from Theta Neurotech Inc. sees the company’s co-founders describe their development of a wearable earpiece that uses an electroencephalography technology and machine learning algorithms to alert epilepsy patients 30 to 60 minutes before they have a seizure.
Standing for live visualization of brain circuits, LVIS Corp launched the cloud-based Neuromatch Access platform as a software as a service to help neurologists and medical professionals review, interpret and analyze electroencephalogram (EEG) data.
Beacon Biosignals Inc. can rest easy now that it has received U.S. FDA authorization of its predetermined change control plan for the Dreem 3s, a wearable sleep monitor that conducts electroencephalograms as users sleep. The authorization allows Beacon to incorporate updates to the Dreem 3S sleep-staging algorithm acquired through machine learning without submitting a new 510(k) application.
Ceribell Inc. launched its initial public offering of more than 10.6 million shares of common stock at $17 and steadily saw the trading value rise, before closing just over $25 on Oct. 11 per share. Ceribell, which developed a portable electroencephalogram for use in intensive care and emergency department settings, expected to gross $180.3 million from the IPO excluding any exercise of the underwriters’ option to purchase additional shares. The IPO will close on Oct. 15.
The first patenting from Encephalogix Inc. details its development of platform that uses machine learning and AI to analyze EEG data that is typically ignored.
In what represents the first patenting to emerge from Braincapture ApS, its chief executive officer, Tue Lehn-Schiøler, describes the development of a low-cost, portable electroencephalogram device designed to enhance neurological diagnostics in underserved communities around the world.
Quantalx Neuroscience Ltd. filed for protection of a system and method for the diagnosis of normal pressure hydrocephalus and prediction of patient response to ventriculoperitoneal shunting surgery treatment. The U.S. FDA granted the company’s Delphi-MD breakthrough device designation for these indications in May 2023.
