Diagnostics & Healthcare News

Baxter International Inc. (NYSE: BAX), a global leader in clinical nutrition, today announced the U.S. Food and Drug Administration (FDA) clearance of Q-NRG+, a metabolic monitoring device utilizing indirect calorimetry (IC) technology. IC is considered the “gold standard”1  to accurately measure a patient’s calorie needs, or resting energy expenditure (REE). These readings can help inform prescription…

CareLight Solutions is proud to now be offering a complete line of industry-leading Light Therapy products to the public. Inspired by Nobel Prize-winning science, Light Therapy devices are backed by years of scientific research and are FDA-cleared to reduce pain and increase circulation. Based in Chicago, CareLight is dedicated to the health and well-being of its…

Intuitive, a global technology leader in minimally invasive care and the pioneer of robotic-assisted surgery, announced it has acquired privately held Orpheus Medical to deepen and expand its integrated informatics platform. Orpheus Medical provides hospitals with information technology connectivity, as well as expertise in processing and archiving surgical video. “The addition of Orpheus will provide…

Serenno Medical, developer of medical devices for patient monitoring in a hospital setting, reveals Sentinel™, a novel, robust device for automatic monitoring and detection of kidney damage in hospitalized patients. The Sentinel device is a continuous urine output monitor that measures urine flow rate and volume in real time. Continuous kidney function assessment allows the early…

Just as some manufacturers hasten to make tests available for the novel Wuhan coronavirus, FDA will convene with industry representatives Monday in hopes of developing a better “roadmap” for how diagnostics are evaluated during and potentially after emergencies. The workshop was planned months before the Chinese outbreak to address the relatively few diagnostics that make…

BioIntelliSense, Inc., a continuous health monitoring and clinical intelligence company, today announces the U.S. commercial launch of its medical grade Data-as-a-Service (DaaS) platform and FDA 510(k) clearance of the BioSticker™ on-body sensor for scalable remote care. BioIntelliSense offers a new standard for Remote Patient Monitoring (RPM) by combining an effortless patient experience with medical grade…

Dimer UVC Innovations is offering its GermFalcon®, a germ-killing robot that sanitizes airplanes, to assist airlines and federal agencies disrupt the spread of a new pneumonia-like illness originating in the Wuhan region of China. The service is being offered at no expense to airlines at select U.S. airports during this crisis. The new virus is a…

Phagenesis Ltd., a pioneering leader in the treatment of dysphagia, is pleased to announce today that the company has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its Phagenyx System. The Phagenyx System is a novel neurostimulation device that helps to restore neurological swallowing control through Pharyngeal Electrical Stimulation. The…

Aidoc, the leading provider of AI solutions for radiologists, today announced that the US Food and Drug Administration (FDA) has cleared its AI solution for flagging Large-Vessel Occlusion (LVO) in head CTA scans, marking Aidoc’s fourth FDA-cleared AI package. Combined with Aidoc’s previously-cleared AI module for flagging and prioritizing intracranial hemorrhage, together they provide a comprehensive AI package…

Seventh Sense Biosystems, Inc. (7SBio) announced today that the company has received U.S. Food and Drug Administration (FDA) 510(k) authorization to extend its existing clearance to include blood collection by laypersons. Regulators are also allowing the device to be used ‘at-home’ for wellness testing. “We’re very excited about this clearance since it represents an unprecedented…