Yes, getting FDA 510(k) clearance for your medical device is something to cheer about. But consider Arterys Inc. It just reported its eighth FDA clearance, this time for a next generation, deep learning cardiac analytics platform. The Cardio AI’s purpose, Arterys CEO John Axerio-Cilies told BioWorld, is to leverage artificial intelligence (AI) and deep learning for analysis of cardiac MRI images that is faster, more accurate and repeatable than ultrasound and other imaging modalities.
The rehabilitation robot market will soon have a new entrant as Able Human Motion SL prepares to launch a next-generation robotic exoskeleton. The Universitat Politècnica de Catalunya spin-off is on a mission to shake up the exoskeleton technology market with a low-cost, lightweight model that can be accessed by anyone with mobility impairments.
Biofourmis Inc. secured $300 million in a series D financing led by General Atlantic, with participation by CVS Health and existing investors. The round lifted the Boston-based company’s valuation to more than $1 billion and unicorn status, according to executives. Biofourmis will use the funds to drive next-stage growth in its virtual care offerings and digital therapeutics (DTx).
Metabolic health platform Ultrahuman Healthcare Ltd. has acquired consumer wearable company Lazy Design Pvt Ltd. India (known as Lazyco) to expand the biomarkers complementing its current wearable, the Ultrahuman M1.
With virtually bent knees and proper posture, Soter Analytics Pty Ltd. raised $12 million in a series A funding round to build on its artificial intelligence (AI)-based ergonomic wearables line that helps workers minimize injuries on the job. The technology tracks all significant shoulder and back movements and provides personalized real-time feedback before improper lifts or twists land users on their backs or in rehab.
Results from a new peer-reviewed study show people develop emotional bonds with artificial intelligence (AI) therapy chatbots in a similar way to in-person therapists. The study evaluated 1,205 people using a mental health app developed by Wysa Ltd. to assist symptoms of anxiety or depression. The chatbot guides users through therapy exercises including cognitive-behavioral techniques (CBT), dialectical behavior therapy, meditation, breathing and yoga to build mental resilience skills.
Clinicians are still at liberty to use medical products outside the labeled indication for use, but the U.S. FDA believes radiologists may be unaware of the limitations of radiological computer-aided triage and notification (CADt) software for intracranial large-vessel occlusion (LVOs). The agency advised clinicians that these programs are not intended for use as a substitute for radiologist review of images, but instead should be used only to flag suspect images as part of an effort to triage these patients.
Diagnostic testing group Clinisys Inc. has acquired cloud-based laboratory operations software company Apollolims in an undisclosed deal. Headquartered in Chertsey, U.K., and Tucson, Ariz., Clinisys will expand its public health, toxicology, and molecular diagnostics offering through the acquisition. The deal builds on the company’s combination with Sunquest and Horizon announced in January.
Akili Interactive Labs Inc. has made grabbing and holding attention a distinguishing feature of its digital therapeutics and overall company strategy. Last month, it made news with its hire of gaming industry veteran Jon David as its chief product officer. Now, a study indicates a new product in development may help people with depression extend their attention span and possibly improve cognition, two common symptoms associated with the mood disorder that are not treated by most medications.
Boston Scientific Corp.’s image-guided programming software, Vercise Neural Navigator with Stimview XT, got the green light from the FDA for use with the company’s deep brain stimulation (DBS) portfolio in patients with essential tremor or Parkinson’s disease. The software, developed in a collaboration with Brainlab AG, provides more sophisticated image-guided programming tools for personalization of the stimulation therapy, halving the time needed for adjustments and increasing precision.