Regeneron to Acquire 23andMe for $256 Million, Expanding Genetics-Driven Drug Discovery Capabilities
• Regeneron Pharmaceuticals has won the bankruptcy auction for 23andMe's assets with a $256 million bid, aiming to maintain the consumer genetics service while enhancing its drug discovery platform.
• The acquisition includes 23andMe's Personal Genome Service, Total Health, Research Services, and Biobank assets, but excludes the Lemonaid Health business.
• Regeneron has committed to prioritizing privacy and ethical use of customer data, working with a court-appointed Customer Privacy Ombudsman to ensure compliance with existing policies.
Philips and Polarean Expand Radiation-Free Xenon MRI Technology for Pediatric Lung Disease
• Philips and Polarean have advanced their strategic partnership to bring radiation-free Xenon MRI technology to children with obstructive lung diseases, potentially extending access to patients as young as six years old pending FDA approval.
• The collaboration integrates Polarean's XENOVIEW 3T Chest Coil with Philips' 3.0T MRI systems, enabling clinicians to visualize lung ventilation in real-time with just two 10-second breath-holds, completing scans in under one minute.
• This technology addresses a critical unmet need in pediatric respiratory care, offering a safer alternative for monitoring chronic conditions like asthma and cystic fibrosis without radiation exposure, particularly important for children requiring repeated imaging.
DEFINE GPS Trial Completes Enrollment: Potential Paradigm Shift in Interventional Cardiology
• The DEFINE GPS trial has completed enrollment, evaluating iFR co-registration technology to improve precision in percutaneous coronary interventions (PCI) and reduce residual ischemia.
• Previous research found 25% of patients leave catheterization labs with residual ischemia after PCI, with 80% of these cases potentially resolvable through additional intervention guided by physiologic assessment.
• The trial's primary endpoint measures major adverse cardiac events over two years, with results potentially influencing international guidelines and establishing a new standard for successful PCI procedures.
Philips Initiates Class I Recall of Tack Endovascular System Due to Safety Concerns
• Philips has recalled its Tack Endovascular System following 20 reported injuries, with the FDA classifying it as a Class I recall due to serious safety concerns.
• The recall affects approximately 3,000 units globally, with potential complications including arterial occlusion, dissection, perforation, and risks of amputation or death.
• Healthcare providers are instructed to immediately cease using all three sizes of the device, with Philips implementing a complete market withdrawal and return process.
Scholar Rock's Phase III Trial Advances Apitegromab Development for Spinal Muscular Atrophy
• Scholar Rock's Phase III clinical trial demonstrates promising results for apitegromab in treating spinal muscular atrophy, marking a significant advancement in neuromuscular disease therapeutics.
• The company's strategic initiatives and positive trial outcomes have attracted favorable analyst attention, leading to optimistic market projections and strengthened investor confidence.
• The development represents a potential breakthrough for SMA patients, offering a novel therapeutic approach that complements existing treatment options.
Quibim Secures $50M Series A to Advance AI-Powered Medical Imaging Diagnostics
• Spanish AI company Quibim has raised $50 million in Series A funding to expand its AI-powered medical imaging biomarker platform for disease diagnosis and research applications.
• The company's technology, already deployed in 170+ organizations worldwide, includes tools for detecting neurodegenerative diseases, various cancers, and liver conditions through advanced imaging analysis.
• Strategic partnerships with major players like Philips, Merck KGaA, Novartis, and Johnson & Johnson position Quibim for significant expansion in the growing AI medical imaging market.
Biotronik's Solia CSP S Lead Under Evaluation for Enhanced Left Bundle Branch Area Pacing
• Biotronik has enrolled the first patient in the second arm of the BIO-CONDUCT study to evaluate the Solia CSP S pacing lead for left bundle branch area pacing (LBBAP).
• The Solia CSP S lead features design enhancements like a fixed helix and optimized distal end, aiming to simplify LBBAP procedures and improve patient outcomes.
• LBBAP is gaining traction as a more physiological pacing method compared to conventional techniques, potentially offering better outcomes for heart failure patients.
• Several vendors, including Medtronic, Boston Scientific, and Abbott, are developing and receiving FDA clearances for LBBAP-related devices and systems.
FDA Clears Philips' ROCC for Remote Radiology Operations
• Philips secures FDA 510(k) clearance for its Radiology Operations Command Center (ROCC), enhancing remote scanning and protocol management capabilities.
• The ROCC system, compatible with various MR and CT systems, connects imaging experts with technologists across different locations.
• A pilot study showed a 9% increase in scanning throughput with no exam recalls, demonstrating the system's efficiency.
• The remote capabilities empower clinicians to deliver timely diagnoses and improve patient care by addressing the shortage of skilled technologists.
FDA Approves Roche's Ventana DP 200 Digital Pathology Platform for Clinical Diagnosis
• Roche has received FDA 510(k) clearance for its Ventana DP 200 digital pathology system, expanding its use from research to clinical diagnosis applications.
• The approved platform includes a slide scanner, workflow software, and display system, enabling pathologists to review and interpret digital pathology slides remotely.
• The global digital pathology market, currently valued at $1 billion, is projected to grow to $3.86 billion by 2032, with over 70% of major pharma companies already adopting the technology.
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