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Masimo Pushes Remote Monitoring System To Reduce Nurse Burnout

 
• By Barnaby Pickering

The partnership between Masimo and University Hospitals of Cleveland will expand the reach of Masimo’s Patient SafetyNet remote monitoring and supplemental alarm system.

Masimo is trying to alleviate burdens on doctors and nurses, reduce costs, and improve patient outcomes with its Patient SafetyNet system for remote patient care management.

Patient SafetyNet is a supplemental remote surveillance and clinician notification system that displays real-time vital sign data – oxygen saturation, pulse rate, respiration rate, total hemoglobin, as well as other...

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X-ray Regulations Detailed In New FDA Guidance

 
• By Brian Bossetta

The US FDA has published final guidance to provide clarification for industry and agency staff on federal regulations of diagnostic X-ray equipment.

Altoida’s Vision For Alzheimer’s Care Combines Digital Screening, Blood-Based Tests, New Drugs

 
• By Marion Webb

Altoida CEO Marc Jones spoke with Medtech Insight about the company’s investigational digital screening tool for Alzheimer’s and the dire need for better, more accessible precision neurology diagnostics as the global population ages, neurologist shortages worsen, and groundbreaking Alzheimer’s drugs change the treatment paradigm.

FDA Publishes Final Guidance For Sponsors Of Decentralized Clinical Trials

 
• By Brian Bossetta

The US FDA is providing recommendations for sponsors conducting clinical trials outside traditional settings, such as individual homes, mobile research units, and remotely via telehealth participation. The agency says the guidance is part of an overall effort to advance how trials are designed and run.

BD Sees Bright Future For Edwards’ Critical Care, Now BD Advanced Patient Monitoring

 
• By Natasha Barrow

Edwards Lifesciences’ Critical Care business “invented the hemodynamic monitoring category, and its solutions are currently used in more than 10,000 hospitals globally to better understand the cardiovascular condition in real-time for critically ill patients, which helps improve outcomes,” says BD, which sees synergies and new innovation opportunities across the groups’ data sets and platforms. Acquired for $4.2bn cash, Critical Care generated more than $900m in revenue in 2023.

More from Device Area

Abbott Announces FDA Approval Of Tendyne Transcatheter Mitral Valve Replacement System

 
• By Marion Webb

Abbott received the US FDA nod for its Tendyne system, offering a minimally invasive alternative to replace the valves of patients with severe mitral valve disease who are at risk for open-heart surgery.

SAGA Diagnostics Launches Early Breast Cancer MRD Detection Test In US

 
• By Natasha Barrow

SAGA Diagnostics has launched its breast cancer residual and recurrence detection test – Pathlight – in the US. The test’s ultrahigh sensitivity and specificity is rare to see in oncology, the company claimed.

FDA Rebukes Four Companies, Including One Overseas, For Procedural Failures

 
• By Brian Bossetta

The US FDA’s device center sent warning letters to three domestic device manufacturers and one German firm for failing to adhere to protocol on several issues.