Despite wide availability and coverage for colonoscopy, many patients diagnosed with colorectal cancer (CRC) have never undergone the recommended screening procedure for the malignancy and its precursors. As a result, the cancer has already spread in the majority of cases at the time of diagnosis. CRC remains the third most common cancer diagnosed in the U.S. and the second leading cause of cancer death for both men and women. Read More
Leadinno Medical Valley Co. Ltd. reported it has raised more than ¥100 million (US$14.5 million) in a series A round for the development of its implantable electrical neurostimulation devices. Read More
The toxicity associated with oncology therapies is the stuff of legend with clinicians and patients, and thus the U.S. FDA and manufacturers have been working to fine tune these dosing regimens. However, the FDA's Oncology Center of Excellence (OCE) includes a programmatic effort to optimize dosing regimens, which led to an editorial by FDA officials that calls on industry to consider whether the maximum tolerated dose paradigm is really the optimal approach to oncology drug development. Read More
The U.S. FDA has granted breakthrough device designation to Potrero Medical Inc. for its AKI Predict machine learning algorithm for the advanced prediction of acute kidney injury (AKI) associated with intra-abdominal hypertension (IAH) in intensive care patients recovering from cardiac surgery. Read More
Magnus Medical Inc. received FDA clearance for a neuromodulation platform to treat major depressive disorder (MDD) in adults for whom antidepressant medication has been ineffective. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Advanced Medical, Broncus, Concept Medical, Healium, IPS Genomix, Metabolon, Nanomix, Panda Health, Qnovia, Respira, Setpoint Medical, Shenzhen Huikang Medical Apparatus, Sight Sciences, Vivita Technologies, Vizient, Wikkon. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ark Surgical, Ventris. Read More
