In a sweet indication of an improving capital market for med-tech companies, Biolinq Inc. landed $58 million in bridge financing to support completion of the U.S. pivotal trial of its intradermal glucose sensor and submission to the U.S. FDA. The round brings the total raised to more than $170 million. With good response so far, the company is optimistic that it can attract more funding in short order. “Biolinq also plans to raise a series C financing of more than $100 million to support commercialization at the end of this year,” Biolinq CEO Rich Yang told BioWorld. Read More
Australia’s Competition and Consumer Commission said it will not oppose Cochlear Ltd.’s proposed acquisition of the cochlear implants business of Denmark’s Oticon A/S after the bone conduction businesses was removed from the deal. Read More
The lingering effects of the COVID-19 pandemic and ongoing recruitment/retention issues are making it difficult for the U.S. FDA’s bioresearch monitoring program to keep up with the on-site clinical research inspections that are a cornerstone of the preapproval process for new drugs, biological products and medical devices. The resulting delays could threaten the approval timelines for many products. Read More
The U.S. FDA posted two device warning letters in the first week of April 2024, including one each to Beckman Coulter Inc., of Brea, Calif., and Agena Bioscience Inc. of San Diego, the former of which was directed toward the Chaska, Minn., facility that manufactures the Beckman Coulter Dxl 9000 analyzer. Read More
Ironically, the first person to be diagnosed with what is now Alzheimer’s disease was missing its major risk factor. When she first began showing symptoms of dementia in 1901, Auguste Deter was not particularly old. Despite Deter’s case, aging is the largest risk factor for developing Alzheimer’s, by a large margin. But “geroscience has not been translated into drugs for Alzheimer’s disease,” Howard Fillit, Alzheimer’s Drug Discovery Foundation co-founder and chief scientific officer, told BioWorld. “We’re just starting to see that cross-fertilization now.” Read More
Carelight Ltd. reported seeking protection for a wearable real time opto-physiological monitoring system for monitoring heart rate, respiration rate, oxygen saturation, blood pressure, heart rate variability, pulse wave velocity, and body temperature. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Monteris Medical, Nucleix, Regenative Labs. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Acclarent, Alamar, Biognosys, Brainlab, Cardio Diagnostics, Carl Zeiss, DORC, Exact Sciences, Fujifilm, Integra, J&J, Medcura. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Affinity Biosensors, Angiodynamics, Click, Haemonetics, Otsuka. Read More
