Archive for February 2020
Aria CV Receives FDA Breakthrough Designation for Its Medical Device for Treating Pulmonary Arterial Hypertension
Aria CV, Inc., a developer of medical devices treating Pulmonary Arterial Hypertension (PAH), today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the Aria CV Pulmonary Hypertension System (Aria CV PH System). The Breakthrough Devices Program (BDP) is intended to expedite the FDA review and approval of designated…
Read MoreSerenno Medical Introduces Novel Device for Continuous Automatic Monitoring of Kidney Function of Hospitalized Patients
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…
Read MoreLapTrainer Mixed Reality Simulator for Laparoscopy Training Unveiled
The long-term collaboration between KARL STORZ and VirtaMed in the domain of medical simulation reaches a milestone with the development of LapTrainer, a cutting-edge hybrid simulator designed to maximize the benefits of simulation in laparoscopy. The new simulator offers a unique training approach enabling medical professionals to acquire key skills with increased efficiency by repetition of…
Read MoreAmid Coronavirus Outbreak, FDA and Industry Seek Roadmap for Emergency Diagnostics
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…
Read More