Outset Medical | MedPath

Spear Bio and Beckman Coulter Receive FDA Breakthrough Device Designations for Alzheimer's Blood Tests

4 months ago

• Spear Bio's pTau 217 blood test received FDA Breakthrough Device Designation, offering a less invasive method for early Alzheimer's diagnosis. • Beckman Coulter's Access p-Tau217/β-Amyloid 1-42 plasma ratio test also gained FDA Breakthrough Device Designation, aiding in identifying amyloid pathology. • Both tests address the critical need for accessible, early Alzheimer's diagnosis, potentially improving patient outcomes and treatment access. • These designations expedite the development and review process, bringing innovative diagnostic tools to market faster for Alzheimer's disease.

Nyxoah Expands Global Reach: Genio Neurostimulation Therapy for OSA Launches in Middle East and England

5 months ago

• Nyxoah has successfully launched its Genio system for obstructive sleep apnea in the Middle East, with the first implant performed at Saudi German Hospital in Dubai, UAE. • The battery-free hypoglossal neuromodulation device has also been commercially launched in England, where the first patients received implants at University College London Hospitals under NHS coverage. • Genio offers a breakthrough alternative for OSA patients who cannot tolerate CPAP therapy, featuring a single-incision procedure and wearable control system with CE mark approval since 2019.

Niraparib Shows Promise in Extending Progression-Free Survival in Epithelial Ovarian Cancer

6 months ago

• Niraparib monotherapy extends real-world progression-free survival (rwPFS) and time to next treatment (rwTTNT) in patients with epithelial ovarian cancer (EOC). • Patients with homologous recombination-deficient (HRd) tumors, particularly those with BRCA-mutated tumors, experienced longer rwPFS and rwTTNT. • Niraparib demonstrates clinical benefit in stage III EOC patients with no visible residual disease (NVRD) after primary cytoreductive surgery (PCS). • Niraparib stands out among PARP inhibitors for its broad frontline maintenance therapy approval in EOC, regardless of BRCA mutation or HRD status.

Personalized Medicine Biomarkers Market Set to Reach $79.26 Billion by 2034, Driven by Precision Oncology and AI

6 months ago

• The global personalized medicine biomarkers market is projected to grow from $21.95 billion in 2024 to $79.26 billion by 2034, representing a CAGR of 13.7% as demand for precision healthcare solutions increases. • Treatment selection dominates the market with 50.2% share, while oncology leads indication segments at 36.0%, reflecting the critical role of biomarkers in matching patients to targeted cancer therapies. • North America currently holds 52.0% of market share, with the U.S. market alone expected to grow at 15.5% CAGR to reach $40.90 billion by 2034, driven by technological advancements and regulatory support.