Amber Therapeutics Ltd. revealed positive data from the first-in-human investigation of its Amber-UI device, an implantable closed-loop bioelectrical therapy for urinary incontinence. Initial results highlight the safety and scalability of the Amber-UI therapy, which has the potential to meaningfully improve quality of life for patients dealing with the condition. Read More
The March 5 meeting of the U.S. FDA’s Medical Imaging Drugs Advisory Committee could be the gateway to the first approved intraoperative technology for use in breast cancer that directly examines the lumpectomy cavity for residual cancer. Read More
Neurocode USA Inc. added Alzpath Dx, a blood test for Alzheimer’s disease screening, to its lab developed tests, making it the first available for commercial use in the U.S. The move stands to make screening for the neurodegenerative disease much more accessible, as recent study results indicate Alzpath’s accuracy rivals PET scans and cerebrospinal fluid tests, the current gold standards, in detecting the signature biomarkers of the disease. Read More
The U.S. FDA has proposed an update to an existing program for user fee reductions for companies grossing less than $100 million, although this latest update is much stingier than that. The update would provide registration fee relief for entities with revenues of $1 million or less, but only if that business is in bankruptcy proceedings, a meager bit of relief considering that registration fees in fiscal 2024 run to less than $7,700. Read More
While preparing a follow-on phase III study of its Cardiamp cell therapy, Biocardia Inc. has mined positive interim data at a mean 20-month follow-up of all patients in the original Cardiamp HF Trial. Read More
Shiratronics Inc. seeks patent protection for a rechargeable subcutaneous neurostimulator implant and a method for managing heat during recharge of its battery from an external device and headset. Read More
Discover a wealth of industry insights with BioWorld’s extensive collection of infographics, covering the latest trends and developments in both biopharma and med-tech. Our weekly infographics are curated to provide concise summaries of key topics: financings (IPOs, private financings, public/other and follow-on offerings), deals and M&As (top deals, and monthly value and volume), regulatory (including U.S. FDA and worldwide approvals), clinical trials and more. In addition, you’ll find access to BioWorld’s year-in-review reports, as well as special infographics about obesity, pain and addiction, biosimilars and the aging space. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Arteraai, Becton Dickinson, Bone Biologics, Clinical Microbiomics, DNASense, Cytomed, Diacarta Inc., Isightec, Nonagen Bioscience. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Diasorin, EDAP TMS, Medtronic. Read More
