Diagnostics company Sphingotec GmbH is looking to break into the U.S. market with a pair of biomarker assays that could help determine the best treatment for critically ill patients at risk for septic shock. The two assays, which are run on the company’s point-of-care Nexus IB10 immunoassay platform, measure bioactive adrenomedullin (bio-ADM), a hormone that maintains endothelial function; and dipeptidyl peptidase 3 (DPP3), an enzyme that inactivates angiotensin II when released into the blood.

Emitbio Inc., a life science company developing light-based therapies, is seeking emergency use authorization (EUA) from the U.S. FDA for its investigational device to treat mild to moderate COVID-19 infection at home. The portable, hand-held device works by directing precise wavelengths of visible light to the back of the throat and surrounding tissues. It is not yet available for sale in the U.S.

Hologic Inc. is teaming up with Google Cloud to use machine learning technologies to improve the accuracy and timeliness of cytology for cervical cancer screening. Marlborough, Mass.-based Hologic, which makes both Pap and human papillomavirus (HPV) assays, is already using artificial intelligence (AI) and machine learning in its new digital cytology platform that is available in Europe. The multiyear collaboration with Mountain View, Calif.-based Google Cloud will start with innovating that product further by enhancing the deep learning component of the system.

Novasignal Corp. has a launched a cloud-based app to provide alerts to clinicians directly from its cerebral ultrasound device. The new app allows physicians to get instant notifications from the company’s Novaguide device, a transcranial doppler ultrasound technology that allows for real-time assessment of blood flow in the brain by combining robotics and artificial intelligence (AI).

IBM Research and Boston Scientific Corp. are harnessing artificial intelligence (AI) to create an objective pain measurement tool that could someday replace standard patient-reported pain scales in the assessment of chronic pain.

Brain Scientific Inc., a neurology-focused device and software company, is seeking to combine a miniaturized electroencephalogram (EEG) with subcutaneous graphene electrodes to produce a minimally invasive brain monitoring device that could provide continuous data on patients with neurological conditions. The device, which the New York-based company is calling the Brain E-Tattoo, would monitor brain wave activity outside the clinical setting, allowing for long-term continuous data collection without interrupting daily life.

Opticyte Inc., a medical device startup, is planning the first clinical trial of its cellular oxygen monitor, a new device that could help emergency physicians diagnose sepsis faster and prevent organ failure. The prospective, observational trial is set to launch in mid-2021.

Helix Opco LLC, a company specializing in population genomics, has received de novo marketing authorization from the U.S. FDA for its whole exome sequencing platform, which covers roughly 20,000 genes. The San Mateo, Calif.-based company also picked up 510(k) clearance from the FDA for the first test to run on the Helix Laboratory Platform, a genetic health risk application for late-onset Alzheimer’s disease. That test has been cleared for over-the-counter use in conjunction with the Helix Laboratory Platform.

Just a week into 2021 and Hologic Inc. is planning another acquisition. The company announced that it has agreed to acquire the molecular diagnostics testing company Biotheranostics Inc. for roughly $230 million cash up front. This comes on the heels of completing the acquisition of Somatex Medical Technologies GmbH for about $64 million. The acquisition of San Diego-based Biotheranostics is expected to close in February 2021, pending antitrust clearance.

A new imaging technology that uses transmission ultrasound to provide a 3D image of breast tissue outperformed traditional digital mammography in a recent retrospective analysis. The study findings could set the stage for the U.S. FDA to clear the technology for breast cancer screening in young, high-risk women.