Wayne, N.J.-based Getinge announces that the U.S. FDA has cleared its Servo-air mechanical ventilator for use on adult and pediatric patients. The device is slated for availability in the U.S. in late 2020.
The U.S. FDA has permitted marketing of the Dexcom G6 integrated continuous glucose monitoring (iCGM) system for determining blood glucose levels in those ages 2 and older. This enables developers of future iCGM systems to bring their products to market in the least burdensome manner possible, FDA officials say.Read More
The entrepreneurial pathway for innovation is rarely a straight line, nor does it often return quick results, maintains Watershed Idea Foundry CEO Nick Cordaro. In this article, Cordaro explains how companies can overcome impediments to medical device advancement.Read More
Morrisville, N.C.-based SunTech Medical, which manufacturers the CT40 spot-check device for blood pressure monitoring, announces that it received third-party validation for blood pressure performance as specified by the British Hypertension Society and AAMI/the International Organization for Standardization.Read More
The U.S. FDA has cleared KD203, a portable multispectral medical imaging device developed by Calgary, Alberta, Canada-based Kent Imaging. KD203 provides insight into the availability of oxygenated blood in tissue, thus streamlining diagnosis, treatment planning, and patient monitoring.Read More
The U.S. FDA has cleared the first duodenoscope with a disposable distal cap, a new feature that will improve access for cleaning and reprocessing. The Pentax ED34-i10T model duodenoscope, manufactured by Pentax of America, is intended to provide visualization and access to the upper GI tract.Read More
The U.S. FDA has recognized four AAMI standards and one technical information report―TIR69, which helps provide a reliable method to assess how well wireless medical device systems are able to operate in an increasingly congested wireless environment.Read More
Nashua, N.H.-based iCAD recently announced that its PowerLook Tomo Detection received FDA premarket approval. PowerLook Tomo Detection is a concurrent-read, computer-aided detection solution for digital breast 3D tomosynthesis and is the latest innovation available on the PowerLook Breast Health Solutions platform.Read More