Siemens Healthineers (ETR: SHL) announced today that it entered into a 15-year strategic contract worth $169.7 million (€140 million). The partnership, inked with Manchester (UK) University NHS Foundation Trust (MFT) is slated to include the planning, installation and maintenance of 222 pieces of critical medical equipment, with approximately 350 planned installations over the life of the contract, […]
Imaging
Longeviti Neuro Solutions ClearFit implant wins FDA clearance for use in ultrasound
Longeviti Neuro Solutions today announced that it received FDA 510(k) clearance or its ClearFit implant for use in ultrasound in post-operative imaging. ClearFit’s FDA clearance allows the device to be used during ultrasound procedures, which carries the risk of radiation exposure with other current post-neurosurgical imaging modalities. “It is our hope that with this new […]
Butterfly Network names new CEO before going public via merger
Butterfly Network announced today that it named Dr. Todd Fruchterman as its new president & CEO, effective Feb. 1. Fruchterman is set to take over for outgoing CEO Laurent Faracci, who stepped down this past weekend. Fruchterman assumes the role in advance of the closing of Butterfly Network’s announced merger with Longview Acquisition Corp., after […]
Canon Medical large bore CT wins FDA clearance
Canon Medical today said it received FDA 510(k) clearance for its Aquilion Exceed LB CT system. Aquilino Exceed is designed to allow clinicians to see more during radiation therapy planning for more accuracy, precision and speed. It supports fast and efficient radiation oncology workflows without compromising patient position, according to the Tustin, Calif.-based company. The […]
TransEnterix receives CE Mark for AI for its robotic surgery system
TransEnterix (NYSE:TRXC) announced today that it received CE Mark approval for its Intelligent Surgical Unit for the Senhance system. The Intelligent Surgical Unit (ISU) enables machine vision capabilities on the Senhance surgical system, providing Senhance digital laparoscopic programs in Europe augmented intelligence capabilities in surgical settings, according to a news release. The FDA cleared the ISU […]
ClearMind neuroendoscope gains FDA clearance
ClearMind Biomedical announced today that it received FDA clearance for its Axonpen novel neuroendoscope system. Los Angeles-based ClearMind Biomedical’s Axonpen system is designed for the illumination and visualization of intracranial tissue and fluids, as well as the controlled aspiration of tissue and/or fluid during surgery, according to a news release. The system requires a 6.5 […]
Philips, InSightec team up on ultrasound for neurosurgery
Royal Philips (NYSE:PHG) announced that it is collaborating with InSightec to expand access to MR-guided focused ultrasound. Amsterdam-based Philips plans to develop compatibility between its advanced MR system and InSightec’s Exablate Neuro platform to expand access to MR-guided focused ultrasound for incision-less neurosurgery in treating essential tremor and other neurological disorders, according to a news release. […]
Genetesis wins FDA breakthrough nod for imaging tech
Cardiac imaging technology developer Genetesis announced today that its flagship product received FDA breakthrough device designation. Mason, Ohio-based Genetesis’ CardioFlux magnetocardiograph (MCG) uses highly sensitive room temperature magnetometers to deliver non-invasive measurements of the heart’s naturally generated magnetic fields, according to a news release. The FDA granted breakthrough device designation for CardioFlux in the diagnosis of […]
Smiths Medical launches Portex EchoGlo peripheral nerve block portfolio
Smiths Medical announced today that it launched its EchoGlo peripheral nerve block portfolio as part of the Portex pain management platform. EchoGlo is a needle designed for echogenic brightness under ultrasound to enhance visualization and accuracy while delivering medication, helping to confidently place local anesthetic which could reduce post-operative dependency on opioids, according to a […]
SoniVie wins FDA breakthrough nod for renal denervation tech
SoniVie announced that it received FDA breakthrough device designation for its Tivus renal artery denervation technology. Tivus (therapeutic intra-vascular ultrasound system) is designed for treating resistant hypertension through renal artery denervation. The system previously received breakthrough designation for treating pulmonary arterial hypertension (PAH) in September 2019. Get the full story at our sister site, Medical Tubing & […]
Cyber vulnerability discovered in GE Healthcare radiological devices
CyberMDX announced that it uncovered a cyber vulnerability across a range of popular devices made by GE Healthcare (NYSE:GE). The U.S. Dept. of Homeland Security’s Cybersecurity and Infrastructure Security Agency (CISA) disclosed the vulnerability yesterday after CyberMDX discovered that it could affect dozens of radiological devices by allowing an attacker to gain access to sensitive data, […]