The digital therapeutics market has seen an explosion of innovative products and interested investors. Regulators, too, have acknowledged their potential to improve outcomes in patients with chronic or debilitating conditions – often at lower cost and with less side effects than traditional drug therapies. To that end, the FDA has granted breakthrough device designation to Swing Therapeutics Inc. for its prescription digital therapeutic for the management of fibromyalgia.
The FDA has given the green light to Spintech Inc. for its STAGE (strategically acquired gradient echo) magnetic resonance imaging device. The post-processing software platform allows MRI technicians to capture higher-quality brain images in significantly less time than standard approaches.
Nihon Kohden Corp. has acquired Advanced Medical Predictive Devices, Diagnostics and Displays Inc. (AMP3D) for an undisclosed sum. The company provides data analytics and artificial intelligence solutions for proactive clinical care. Charlottesville, Va.-based AMP3D owns a large library of clinical predictive algorithms, as well as the Continuous Monitoring of Event Trajectories predictive analytics platform. The latter, a software-as-a-service platform, leverages patients’ continuous monitoring data, vita signs, medical records and laboratory tests to display patients’ risk trajectories, both in current and continuous time.
Zoll Medical Corp. has released its Remedē EL-X system for the treatment of central sleep apnea in adults, following the receipt of FDA approval. The next-generation implantable neurostimulation device will be rolled out in a phased launch in implanting centers in the U.S.
Abbott Laboratories has secured FDA clearance for its latest optical coherence tomography (OCT) imaging platform powered by the company’s new Ultreon software. The artificial intelligence (AI)-powered imaging software allows doctors to view coronary blood flow and blockages more clearly, aiding in care management and treatment decisions.
Iterative Scopes Inc. picked up $30 million in series A financing to advance artificial intelligence (AI)-powered precision medicine for gastroenterology. The money will be used to further develop the company’s algorithms and to propel its growing life sciences businesses. Spun out of the Massachusetts Institute of Technology by founder and CEO Jonathan Ng, the company is developing AI-driven computational tools to identify appropriate treatments and guide clinical trials for patients suffering from gastrointestinal diseases.
Intervenn Biosciences raised $201 million in a series C financing led by new investors Softbank Group, Heritage Provider Network, Irving Investors and Highside Capital Management. The proceeds are earmarked to speed development and commercialization of Dawn, a liquid biopsy assay for immune checkpoint inhibitor prediction, and to expand the network of partnerships on the company’s artificial intelligence (AI)-driven glycoproteomics platform.
Post-traumatic stress disorder (PTSD) affects about 8 million Americans a year, disrupting lives with nightmares, memory loss, feelings of isolation and other negative effects. Treatment typically involves psychotherapy, but many patients do not find relief. To that end, the FDA has granted breakthrough device designation to Evren Technologies Inc. for its noninvasive Phoenix earbud device for treating PTSD.
Biofourmis Inc. won a breakthrough devices nod from the FDA for its Biovitalshf solution, a digital therapeutic for patients with heart failure with reduced ejection fraction (HFrEF). The company, which is pursuing the de novo pathway for the therapy, plans to launch a pivotal trial next month. Biovitalshf is intended to augment guideline-directed use of heart failure medications to manage patients in combination with traditional pharmacotherapy. The software application integrates physiological monitoring, symptoms and signs reporting, patient engagement, medication management and communications to provide clinicians with personalized and specific recommendations about their medication.
Medtronic plc got a thumbs up from the FDA for two Accurhythm algorithms to detect atrial fibrillation and asystole in patients who have heart rhythm abnormalities. The new artificial intelligence (AI)-based algorithms are designed for use on the company’s Linq II insertable cardiac monitor (ICM). Dublin-based Medtronic said the Accurhythm AI algorithms will be available on its Carelink Network later this year for use with all implanted Linq II devices in the U.S.
