InPen Insulin bolus calculator, Surfacer catheter system, and RESPMETER

Published by Daniel at March 1, 2022

Controlling blood sugar without an insulin pump? Allowing access to obstructed veins for hemodialysis? Saving lives through detecting...

Companion Medical Receives FDA Clearance for InPen Insulin Bolus Calculator

Companion Medical announced it gained FDA approval for its insulin bolus calculator for fixed doses and meal estimations. The calculator will be used in conjunction with the InPen system to provide dosing suggestions based on patients’ current glucose levels and surrogates of insulin activity from previous doses, allowing correction of high blood glucose between meals harmlessly. This system comprises an injector pen that synchronizes with a mobile app via Bluetooth. The app then calculates and recommends optimal insulin doses, monitors its temperature, reminds users to use it, and displays the last dose and active insulin levels. It can also create reports for healthcare providers using data transmitted from the pen. The new bolus calculator recommends doses based on previous administrations, current blood glucose level, and the approximate size of the next meal.(1)

Surfacer FDA Cleared for Unusual Dialysis Central Venous Access

The right internal jugular vein is the ideal entry point for performing hemodialysis via a central venous catheter. Nevertheless, nearly half of the patients present an obstruction that makes this challenging or impossible. The Surfacer Inside-Out Access Catheter System, authorized by the FDA De Novo classification, can penetrate the obstruction and use it as support to restore access to the vein. This alternative is significantly better than the now-popular option of creating an AV fistula using different vessels as it has improved outcomes in dialysis patients and increased cost-efficiency.

The device is passed through the right femoral vein and up into the right internal jugular, resting inside the obstruction. From there, the Surfacer’s needle wire is released while pushing the sheath into the vein to position the catheter. The block, in this case, acts as an anchor for the needle during this procedure, turning a hurdle for traditional catheter placement systems into an advantage.(2,3)

RESPMETER Opioid Overdose Detector Wins FDA Breakthrough Device Status

Altair Medical recently published that it obtained the FDA Breakthrough Device status for its RESPMETER wearable biosensor. The biosensor is a chest-worn wireless sensor that can recognize Opioid-Induced Respiratory Depression (OIRD), a frequent and often fatal side effect of using opioid analgesics. This biosensor can monitor respiratory patterns and interpret them using proprietary algorithms. When the device recognizes OIRD in the wearer, it sends an alert to designated first responders, who can intervene by administering naloxone. Altair Medical believes that the RESPMETER wearable biosensor will play an essential role in the global opioid epidemic. OIRD causes 1,000 deaths per week in the UK and the USA and is now the most significant cause of accidental death in developed nations. .(4)