Baxter International Inc. has joined forces with Miromatrix Medical Inc. to advance the development of bioengineered organs for patients with acute liver failure (ALF). Under the collaborative research agreement, Baxter will combine its Prismax system with Miromatrix's single-use bioengineered liver, miroliver, to provide external support to patients' native livers as they await transplant or potential regeneration. Read More
Precisedx Inc.’s digital artificial intelligence (AI) platform better predicts the recurrence of early-stage breast cancer within six years than traditional testing, a study published in Breast Cancer Research found. Understanding which patients with early-stage disease face significant risk of their cancer returning is important for guiding selection of treatment. The system reduces the variability inherent in histological characterization and grading of breast cancer (BC) today, thereby improving prognostic accuracy. Read More
Ottawa-based start-up Realize Medical Inc. reported U.S. FDA clearance of virtual reality (VR) surgical planning software to help physicians create and share complex patient anatomy from CTs and MRIs in an immersive 3D environment. Company CEO Justin Sutherland told BioWorld clearance of the Elucis platform “is a crucial milestone” that will benefit hospitals and his company well into the future. Read More
The U.S. FDA inked a Dec. 20, 2022, warning letter to Righteye LLC that handed the company a list of quality system issues in dire need of redress, but the agency was more concerned about off-label promotion of the Righteye vision system as a method for evaluating the patient’s ocular tremors as a sign of Parkinson’s disease. Read More
New York-based Paige.AI Inc., was successful in its de novo application to the U.S. FDA for the company’s digital pathology software for identification of cancerous prostate tissue, but the agency needed nearly a year and a half after the September 2021 grant of de novo petition to post the regulation for this novel algorithm. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alternative Source Medical, Apyx Medical, Meridian Bioscience, Neovasc, SD Biosensor, Sense Biodetection, Sherlock Biosciences. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bausch + Lomb, Modulight. Read More
