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Clinical Trial News

FDA Gives Authorization for First Over-the-Counter Hearing Aid Software Device - HCPLive

The FDA authorized the first over-the-counter hearing aid software, customizable for mild to moderate hearing loss in adults, compatible with Apple AirPods Pro. This aims to improve accessibility and convenience for hearing support. The Hearing Aid Feature includes a self-fitting mobile app on iOS, assessed through the FDA's De Novo pathway.

Yunu Extends Free Cancer Center Use of Platform for All Children's Oncology Group Clinical Trials

Yunu extends free use of its clinical trial imaging platform for all Children’s Oncology Group (COG) trials, aiming to enhance pediatric cancer care by providing world-class imaging capabilities and reducing error rates to near zero.

CureVac Partner GSK Announces Positive Phase 2 Data from Seasonal Influenza mRNA ...

CureVac N.V.’s press release includes forward-looking statements about future events and results, such as potential vaccine efficacy, strategies, financing plans, and market growth. These statements are not guarantees and are subject to risks, including economic conditions, regulatory approval, competition, and the COVID-19 pandemic. The company does not update forward-looking statements and advises readers to consult SEC filings for further information.

Medtronic scores FDA approvals for several new therapies to drive sales - Star Tribune

Dr. Robert McGovern implanted the latest Percept system in Bruce Lunde, treating his Parkinson's tremors. Medtronic also received FDA approval for Inceptiv, a spinal cord stimulator for chronic pain, which can automatically adjust therapy.

Shorter-course radiation better option for breast cancer patients than conventional schedule

Hypofractionation reduces side effects and improves quality of life in breast cancer patients, with similar survival and recurrence rates to conventional fractionation, making it a safer, more convenient, and cost-effective option.

Vera Therapeutics Completes Enrollment for Primary Endpoint in Pivotal Phase 3 ORIGIN 3 ...

Vera Therapeutics completed early enrollment for ORIGIN 3 trial of atacicept in IgAN, with 200 participants for 36-week UPCR primary endpoint. Topline results expected Q2 2025, and 96-week data from ORIGIN Phase 2b trial to be presented Q4 2024.

Richmond Clinical Trials seeks volunteers for vaccine studies

Richmond Clinical Trials seeks participants for vaccine studies on RSV/hMPV and Norovirus, aiming to advance medical knowledge and treatments. Volunteers aged 19+ with managed health conditions like asthma, COPD, or diabetes are needed. Participants will be reimbursed and contribute to critical data on medication effectiveness.

FDA Approves Arthroscopic Knee Cartilage Repair - Orthopedics This Week

FDA approves arthroscopic delivery of MACI®, an autologous cultured chondrocytes on porcine collagen membrane, for knee cartilage defect repair, offering a less invasive option for patients.

Trimodal Therapy Promising for Recurrent High-Grade T1 Bladder Cancer

Trimodal therapy shows potential as an alternative to radical cystectomy for recurrent high-grade T1 bladder cancer, with 88% of patients avoiding cystectomy at 3 years post-treatment. The therapy, involving radiation with radiosensitizing chemotherapy following repeated transurethral resection, reported overall survival rates of 69% at 3 years and 56% at 5 years, with 12% and 19% distant metastasis rates, respectively. Despite limitations in cohort size and participant heterogeneity, the study suggests this approach could be considered in place of cystectomy.

An injectable HIV-prevention drug is highly effective — but wildly expensive

Lenacapavir, a long-acting HIV-prevention drug, showed 89% more effectiveness than daily oral medication in clinical trials, raising hopes for broad, equitable rollout to combat HIV. However, its high cost poses a challenge, with no indication yet of a different price for PrEP use.
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