Posts by cstephenson@legacymedsearch.com
World’s First Bedside MRI System Receives FDA 510(k) Clearance
Hyperfine Research, Inc. announced today that it has received US Food & Drug Administration 510(k) clearance for the world’s first bedside Magnetic Resonance Imaging (MRI) system, clearing the way for device shipments this summer. The Hyperfine system is 20X lower cost, 35X lower power consumption, and 10X lower weight than today’s fixed conventional MRI systems.…
Read MoreIntuitive Acquires Orpheus Medical to Expand Informatics Platform for Hospitals
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…
Read MoreFDA Grants De Novo Clearance to Bluegrass Vascular Technologies for the Surfacer Inside-Out Access Catheter System
Bluegrass Vascular Technologies (Bluegrass Vascular), a private medical technology company focused on innovating lifesaving devices and methods for vascular access procedures, announced today that the U.S. Food and Drug Administration (FDA) has granted a De Novo classification order for its Surfacer® Inside-Out® Access Catheter System. The Surfacer System is intended to obtain central venous access to facilitate catheter insertion into…
Read MoreFDA Clears Paragonix Technologies’ LUNGguard for Donor Lung Preservation
Paragonix Technologies, Inc. today announced clearance of a Pre-Marketing Notification (510(k)) with the US Food and Drug Administration (FDA) for its Donor Lung Preservation System – LUNGguard1,2. The Paragonix LUNGguard Donor Lung Preservation System is intended to be used for the static hypothermic preservation of lungs during transportation and eventual transplantation into a recipient using cold…
Read MoreIn2Bones Receives FDA 510(k) Clearance for Quantum Total Ankle
In2Bones Global, Inc. today announces clearance from the U.S. Food and Drug Administration to market the Quantum™ Total Ankle. This new total ankle replacement system treats patients who suffer from arthritis and is designed to improve patient mobility, increase stability, and technologically advance implant placement based on patient-specific anatomy. Compared to current total ankles on the…
Read MoreAria 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 MoreBIONIK Laboratories Announces Regulatory Approval and First Sale of its InMotion ARM Robotic Technology by its Exclusive Distributor in South Korea
BIONIK Laboratories Corp., a robotics company focused on providing rehabilitation and assistive technology solutions to individuals with neurological and mobility challenges from hospital to home, today announced it has received regulatory approval in South Korea, and that its exclusive distributor Curexo secured the first sale for BIONIK’s InMotion® robotic technology in the country, out of…
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