Tubeless insulin delivery system, smartphone control
The U.S. Food and Drug Administration (FDA) cleared the Insulet’s Omnipod 5 Automated Insulin Delivery System (Omnipod 5) for individuals aged six years and older with type 1 diabetes.
The System consists of the tubeless Pod enhanced with SmartAdjust technology, the Dexcom G6 CGM, and the Omnipod 5 mobile app with its integrated SmartBolus Calculator. The user can download this app onto a compatible personal smartphone or to use the Omnipod 5 Controller, provided free with the first prescription.
Every five minutes, SmartAdjust receives a Dexcom CGM value and trend, and predicts where glucose will be 60 minutes into the future. The system increases, decreases, or pauses insulin delivery using the user’s desired and customized glucose target, helping to protect against highs and lows.
https://insulet.com
Non-invasive cardiac monitoring device approval
The Cardiac Performance System (CPS) was granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA). As part of this designation, the FDA will work closely with Sensydia to expedite the development of CPS and prioritize the review of subsequent regulatory submissions.
CPS is a non-invasive cardiac monitoring device that reports critical heart performance measurements to physicians for comprehensive evaluation of patients with advanced and persistent heart failure, without requiring an in-hospital catheterization procedure or ultrasound assessment.
Through its ultra-sensitive biosensors, CPS acquires heart sound data and applies machine learning (ML) to compute multiple hemodynamic measurements, delivering all in one comprehensive report via the CPS iPad app. CPS can measure ejection fraction (already FDA cleared), cardiac output, pulmonary artery pressure, and pulmonary capillary wedge pressure simultaneously.
https://www.sensydia.comEnterprise labeling solutions for medtech
Loftware acquired PRISYM ID, expanding Loftware’s Enterprise Labeling solution offerings for the medical device and pharmaceutical industries while enhancing Loftware’s end-to-end cloud-based labeling platform by adding advanced clinical trial labeling and regulated content management capabilities.
Building on PRISYM ID’s industry focus, Loftware’s offering customers new levels of innovation to help enable compliance through accurate, validation-ready labeling solutions and regulated product content, while also growing the Loftware platform and offering more services to these strategic markets. The platform empowers companies to optimize continuity, improve agility, and enable traceability as they’re faced with new and ensuing challenges around today’s complex supply chain.
This acquisition helps customers tackle the challenges of clinical trial labeling, performed either in-house, through clinical research organizations, or through clinical development & manufacturing organizations.
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