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.

Ultromics Ltd. received U.S. FDA 510(k) clearance for its artificial intelligence-driven decision support tool for the diagnosis of coronary artery disease (CAD). Used in conjunction with a clinician's assessment, Echogo Pro's algorithms improve disease prediction and support more accurate diagnosis. Echogo Pro is a stress-Echo module in the Oxford, U.K.-based company's Echogo suite for CAD diagnosis.

Bioserenity SAS has gained U.S. FDA clearance for the Neuronaute electroencephalography (EEG) system and Icecap EEG wearable device, which aim to help physicians remotely monitor and assess electrical brain activity of people with epilepsy. The company noted that the Icecap and Neuronaute system will facilitate access to care in a variety of settings, including rural and remote environments.

Airehealth Inc.'s management took a deep breath on hearing that the company's Vitalmed nebulizer received U.S. FDA 510(k) clearance after waiting nearly 11 months. The portable, electronic, vibrating mesh nebulizer will connect to the Orlando, Fla.-based company's diary companion app early next year as part of an integrated suite of products designed to help individuals with chronic respiratory issues track symptoms and better manage their care.

For the 795,000 Americans who suffer a stroke each year, time is brain. The U.S. FDA granted 510(k) clearance to a solution the developer says could cut time-to-treatment in stroke by an hour, preserving 3.6 years of healthy life. Nico.lab’s artificial intelligence-based CT scan analyzer, Strokeviewer LVO, uses an algorithm that enables faster triaging of stroke patients and enables physicians to see the location of occlusions in minutes.

The U.S. FDA has granted 510(k) clearance to Siemens Healthineers AG for AI-Rad Companion Organs RT, the newest module in its platform of artificial intelligence-based software assistants. The radiation therapy planning aide joins earlier AI-Rad Companion modules for interpreting magnetic resonance imaging (MRI) studies of the brain and prostate, as well as one for chest computed tomography (CT) studies.

The U.S. FDA cleared Alivecor Inc.'s Kardia AI V2 interpretive electrocardiogram (ECG) algorithm for use in its personal ECG app and devices. Currently, the Kardia line permits consumers to take a 30-second medical grade ECG at home and instantly see whether they are exhibiting symptoms of atrial fibrillation, bradycardia, tachycardia or have normal heart rhythm.

The U.S. FDA granted 510(k) clearance to Lantheus Holdings Inc.'s artificial intelligence (AI)-enhanced automated bone scan index (aBSI) product for prostate cancer on GE Healthcare's Xeleris platform. ABSI improves quantification and management of disease progression in advanced prostate cancer patients.

Abiomed Inc. has won the U.S. FDA’s nod for its Breethe Oxy-1 device, an all-in-one, compact cardiopulmonary bypass system designed for easy mobility. The company plans a controlled release at U.S. hospitals between now and March of 2021, with widespread availability later that year.

Aidoc Inc., a provider of artificial intelligence (AI) solutions in radiology, has won U.S. FDA clearance to market the first software solution for flagging and triaging incidental pulmonary embolism (PE). The AI technology, which includes triaging and notification algorithms, is an “always on” technology that analyzes chest CT scans in real time and alerts the radiologist to any potentially abnormal findings – possibly speeding up diagnosis by hours.