Annette Boyle

Electrocore Inc. Quell(ed) any concerns about its commitment to the bioelectronic health segment with an agreement to acquire Neurometrix Inc., maker of the Quell, a wearable device and cloud-enabled neuromodulation platform to treat fibromyalgia and lower extremity chronic pain. Neurometrix is expected to divest its other primary product, Dpncheck, a point-of-care screening test for diabetic peripheral neuropathy, prior to the acquisition.

Electrocore Inc. Quell(ed) any concerns about its commitment to the bioelectronic health segment with an agreement to acquire Neurometrix Inc., maker of the Quell, a wearable device and cloud-enabled neuromodulation platform to treat fibromyalgia and lower extremity chronic pain. Neurometrix is expected to divest its other primary product, Dpncheck, a point-of-care screening test for diabetic peripheral neuropathy, prior to the acquisition.

Movano Inc., dba Movano Health, added some clinical-grade glitz to its Evie ring with a U.S. FDA clearance for the built-in pulse oximeter. Movan’s stock shot up from an all-time low within minutes of the announcement on Dec. 2, as the clearance breathes new life into Movano’s plans to position the ring as a medical device.

Johnson & Johnson received U.S. FDA investigational device exemption to begin the pivotal clinical trial for the Ottava robotic surgical system. If the trial goes well, Ottava could pose a significant challenge to decades-long dominance of the robotic surgical market by Intuitive Surgical Inc.’s Da Vinci system.

The U.S. FDA cleared Paragonix Technologies Inc.’s Kidneyvault portable renal perfusion system, which combines digital monitoring capabilities and hypothermic perfusion technology to preserve donor kidneys during transportation.

Qnovia Inc. received U.S. FDA clearance to start its clinical trial for Respirx, a nicotine inhaler designed as a replacement therapy for smoking.

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.

Exact Sciences Corp.’s Cologuard Plus received U.S. FDA pre-market approval as a non-invasive colorectal cancer home screening test. The next-generation, stool-based assay, developed in conjunction with the Mayo Clinic, reduces false positives by 30% compared to the original Cologuard test without diminishing its sensitivity for cancer or advanced adenomas.

GE Healthcare Technologies Inc. received U.S. FDA approval for its novel radiotracer, Flyrcado (flurpiridaz F-18), for use in the diagnosis of myocardial ischemia or infarction in patients with known or suspected coronary artery disease.

Neuros Medical Inc.’s Altius direct electrical nerve stimulation system significantly reduced pain in 30 minutes and continued to reduce pain for a year, a study published Sept. 24, 2024, in Neuromodulation: Technology at the Neural Interface found.