Fujifilm Healthcare Americas announced today that it began the U.S. launch of its FDR Cross hybrid c-arm and portable X-ray system. Fujifilm designed the FDR cross solution for hospitals and ambulatory surgery centers (ASC). The company said in a news release that the dual-function c-arm is the first of its kind to offer portable fluoroscopic […]
Imaging
RefleXion closes $125M debt facility
Biology-guided radiotherapy (BgRT) technology developer RefleXion Medical announced today that it closed a $125 million debt facility. Hayward, California–based RefleXion has $55 million of the $125 million total available immediately to repay its existing $50 million in debt. The remaining $70 million will be made available upon the achievement of certain regulatory and commercial milestones. […]
New data backs Aerin’s RhinAer for treating chronic rhinitis
Aerin Medical today announced the publication of positive results from a 12-month study of its RhinAer platform. Results from Sunnyvale, California–based Aerin’s Rhintrac randomized, sham-controlled clinical trial, published in the International Forum of Allergy & Rhinology (IFAR), demonstrated that chronic rhinitis symptoms continued to improve through 12 months after treatment with RhinAer. Findings build on […]
Enovis completes Insight Medical acquisition
Enovis (NYSE:ENOV) announced today that it acquired orthopedic surgical guidance company Insight Medical Systems. Wilmington, Delaware-based Enovis — the parent company of DJO Global — did not disclose financial terms for the acquisition of Insight, which develops its flagship Arvis FDA-cleared augmented reality platform for hip and knee replacement surgery. In March 2021, DJO as […]
FDA clears Intuitive, Siemens Healthineers imaging integration for robotic bronchoscopy
Intuitive (Nasdaq:ISRG) announced that the FDA cleared an integration of imaging technology with the Ion robot-assisted bronchoscopy system. The integration covers a mobile cone-beam CT (CBCT) imaging technology, developed by Siemens Healthineers, called Cios Spin. Cios Spin offers integrated functionality with Ion to provide 2D and 3D imaging during procedures to help physicians gain confidence […]
Clarius partners with ImaCor on handheld hemodynamic ultrasound tech
Clarius Mobile Health announced today that it partnered with ImaCor to make available a handheld transesophageal echocardiography (TEE) system. According to a news release, the partnership will enable the availability of the world’s first handheld TEE system designed to manage and guide care for critically ill patients in the intensive care unit (ICU). ImaCor designed […]
Centerline Biomedical raises $33M Series B
Centerline Biomedical announced that it closed a $33 million Series B equity financing, led by Cleveland Clinic. GE Healthcare, RIK Enterprises, JobsOhio, Jumpstart Ventures and G2 Group Ventures all participated in the financing, which will be used to help propel the Cleveland-based company into new surgical applications, accelerate its commercial sales and add to its […]
Varian wins FDA IDE for Flash radiation therapy
Varian announced today that it received FDA investigational device exemption IDE to advance its Flash clinical research program. Flash therapy, an experimental treatment modality, was designed to deliver radiation therapy at ultra-high dose rates in typically less than one second. The Siemens Healthineers company will conduct the feasibility study of Flash therapy for the treatment […]
Vektor Medical names Rob Krummen as CEO
Vektor Medical this week announced that it appointed Rob Krummen as CEO. Krummen previously served as president and chief operating officer of the San Diego-based company. He was responsible for the clinical, regulatory, engineering and operations and will continue to oversee the efforts while growing the company’s commercial and sales teams as CEO. The company […]
FDA grants breakthrough nod for Carthera’s SonoCloud-9
Carthera announced today that it received FDA breakthrough device designation for its SonoCloud-9 system. Paris-based Carthera designed SonoCloud-9 for implantation in a skull window below the skin. Once in place, the device becomes invisible. When activated for a few minutes using a transdermal needle connected to an external control unit, it uses low-intensity pulsed ultrasound […]
Sidekick Health and Eli Lilly partner on digital therapeutics for breast cancer
Sidekick Health today announced a collaboration on an integrated digital therapeutics solution in conjunction with Eli Lilly (NYSE:LLY). The collaboration between the companies will mark the first phase of a relationship between Sidekick and Lilly, which starts with a digital therapeutic offering for patients battling breast cancer. According to a news release, the first phase […]