The U.S. CMS waded into controversy with two final rules calendar year 2022, drawing fire from device makers and doctors who allege that cuts in rates for physicians will hamper beneficiary access. Software developers working in the telehealth space will find much to cheer, however, given that some telehealth services that were covered during the COVID-19 pandemic will be covered after the pandemic has passed. Read More
The FDA has granted Magstim Co. Ltd. 510(k) clearance for its transcranial magnetic stimulation (TMS) platform Horizon 3.0. TMS is a series of repetitive, focused magnetic pulses, used to stimulate brain cells. The noninvasive therapy has been touted as a cost-effective treatment for depression and is typically prescribed when antidepressants have failed, or the side effects are too disruptive to a patient’s lifestyle. Read More
Allara Health Inc. officially launched its diagnostic test for polycystic ovary syndrome (PCOS) this week, but word of mouth has already established a waitlist of more than 10,000 women. The diagnostic tool evaluates a full panel of hormonal and metabolic markers, which are used with patient-reported symptoms, to diagnose the increasingly common condition. Read More
Jubliee Biotech Co. Ltd. is hoping to get FDA clearance with Jubiwatch, its smartwatch and medication management platform. “We aim to obtain FDA pre-submission between April and June 2022, and hopefully hit the U.S. market at the end of 2023,” Sung Kyoung Lee, CEO at Jubliee Biotech, told BioWorld. Read More
TORONTO – Trillium Health Partners has received a C$1 million (US$810,000) grant from TD Bank Group to help accelerate the use of artificial intelligence (AI) at a newly developed health care lab. The AI Deployment and Evaluation (AIDE) lab will determine if machine learning models developed by industry and academia work well outside the data sets upon which they were trained. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Activ Surgical, Natera, Sera Prognostics. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aditxt, Betternight, Clario, Cytek Biosciences, Exact Sciences, Heartflow, Innovia, Molex, Nanostring Technologies, Peerbridge Health, Phillips-Medize, Sleep Data Services. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Insightec, Lumos Diagnostics, Mim Software. Read More
