Augmedics Inc., a Chicago-based startup focused on augmented reality (AR) applications in health care, has scored a 510(k) clearance from the U.S. FDA for its Xvision Spine system. The company launched the device, which provides surgeons with X-ray quality insights into a patient’s anatomy and real-time surgical navigation, on Monday, with distribution slated to begin in the new year. While the FDA has cleared other AR products, Xvision Spine (XVS) is the first to be indicated for guided surgery.
Heart failure is a leading cause of disability and death in the U.S., but many cases are diagnosed late due to limited access to echocardiography, the primary method of detecting the condition. To address that need, the U.S. FDA has granted breakthrough device designation to Eko Devices Inc., of Berkeley, Calif., for an electrocardiogram (ECG)-based algorithm that could serve as an easily accessible screening tool for heart failure during routine physical exams.
Digital therapeutics have made great strides in recent years, with Pear Therapeutics Inc. playing a key role. Now, the company has reported the dosing of the first patient in part two of a study assessing Pear-006 – which Pear Therapeutics is developing in collaboration with Basel, Switzerland-based Novartis AG – to address depressive symptoms in multiple sclerosis (MS).
PARIS – A team of medical researchers and engineers from the Gustave Roussy Institute, in Villejuif, France, and Paris-Sud University recently developed an artificial intelligence system called Resolved2, designed to assess prospective cancer drugs. As Loïc Verlingue, lead cancer specialist on the data science team at the Gustave Roussy Institute, explained to BioWorld MedTech, “this AI is intended to predict efficiently whether a cancer treatment molecule will achieve authorization or not within six years of pharmacological data and phase I clinical trials.”
HONG KONG – Boston-based consulting firm Analysis Group Inc. will be working with China’s Institute of Hematology & Blood Diseases Hospital (IHBDH) on developing a first-of-its-kind blood disease research platform. The National Longitudinal Cohort of Hematological Diseases in China (NICHE) is set to hold the information of more than 10,000 patients across China.
Telemedicine and robotic medicine have reshaped the provision of health care services during one of the largest annual gatherings in the world – health care that the government of Saudi Arabia provides free of charge to all pilgrims. The logistics associated with the spike in demand for health care can be daunting, but advances in medical technology have made this challenge easier.
TORONTO – Montreal’s Dialogue Technologies Inc. has received class 1 CE marking for artificial intelligence (AI)-powered software that enables the company’s existing telehealth platform to reduce the time required to triage patients in emergencies. The new AI-driven Dialogue Intake software also has “human-in-the-loop” capability ensuring real-time medical intervention to verify the accuracy of information provided physicians during telehealth consultation.
Caresyntax GmbH, a Berlin-based provider of surgical automation, analytics and AI software technologies, picked up $45.6 million in venture funding. The funds will be used to accelerate U.S. and global expansion and support continued development and deployment of Caresyntax products. Participating in the financing were Whiz Partners, a Takeda-back drug discovery gateway investment limited partnership, Plug and Play Tech Center, Barco Healthcare, Mitsubishi Corp., Relyens, IPF Partners and Caresyntax founders Dennis Kogan and Bjoern von Siemens.
Irving, Texas-based Caris Life Sciences Inc. has launched an AI-based genomic profiling test to better characterize cases of cancer of unknown primary origin (CUP) and atypical cases and offer appropriate treatment options. Known as the MI GPS (Genomic Profiling Similarity) Score, the analysis is based on an AI analysis of a 592-gene panel of all the clinically relevant genetic biomarkers for cancer.
A pair of Israeli health tech companies, Beyond Verbal and Healthymize, plan to merge to form Newton, Mass.-based Vocalis Health. The company will be focused on developing vocal biomarkers, which track voice patterns via phone calls or smart devices to screen for various voice-indicating ailments including chronic respiratory and cardiac conditions, as well as depression. Vocalis has raised a $9 million financing led by Israeli health tech and life science venture firm Amoon to accumulate additional clinical data and enhance its voice database.