RefleXion announced today that it entered into a clinical collaboration with Merck to evaluate Merck’s (NYSE:MRK) Keytruda anti-PD-1 therapy in clinical trials. Hayward, Calif.-based therapeutic oncology company RefleXion is joining forces with Merck to evaluate Keytruda’s safety and efficacy in combination with RefleXion’s biology-guided radiotherapy (BgRT) in multiple late-stage cancers, including non-small cell lung cancer, in […]
Imaging
FDA clears United Imaging’s MRI
Medical imaging and radiotherapy outfit United Imaging announced today that it received FDA clearance for its UMR Omega MRI scanner. Shanghai-based United Imaging, which has a U.S. base in Houston, touts the UMR Omega as having the world’s first ultra-wide 75 cm bore to provide a patient-centric experience for accomodating wide range of patients, according […]
FDA clears 4D Medical’s lung imaging technology
4DMedical announced that it received FDA clearance for its XV Technology for analyzing functional lung impairment from a single X-ray. Australia-based 4DMedical (formerly 4DX), which has a U.S. base in Woodland Hills, Calif., designed the XV Technology as a four-dimensional lung imaging process in the form of a software-as-a-service (Saas) diagnostic tool. The software rapidly […]
Zebra Medical Vision wins FDA clearance for AI to predict osteoporosis
Zebra Medical Vision announced today that it received its fifth FDA 510(k) clearance for its Vertebral Compression Fractures (VCF) product. The Kibbutz Shefayim, Israel-based company’s latest artificial intelligence-based product automatically identifies findings suggestive of compression fractures, which enables clinicians to place patients that are at risk of osteoporosis in treatment pathways that can prevent potentially […]
FDA clears ophthalmic camera from Optina Diagnostics
Optina Diagnostics announced today that it received FDA 510(k) clearance for its Mydriatic Hyperspectral Retinal Camera (MHRC-C1). The Montreal-based company’s ophthalmic camera captures images of the retina at multiple wavelengths under mydriatic conditions to provide eye care practitioners with a series of monochromatic images obtained in less than one second, according to a news release. […]
Philips lands 510(k) to market ultrasound systems for COVID-19
The FDA has granted Royal Philips (NYSE:PHG) 510(k) clearance to market a wide range of its ultrasound systems to help manage COVID-19-related lung and cardiac complications. Handheld and portable ultrasound solutions in particular have become valuable tools for clinicians treating COVID-19 patients due to their imaging capabilities, portability and ease of disinfection, according to Philips. The 510(k) […]
FDA OKs Aspenstate’s portable X-ray for COVID-19 fight
Aspenstate announced today that FDA has cleared its Airtouch portable X-ray, which the Plano, Texas–based company is touting as a simple frontline chest X-ray tool to help diagnose COVID-19. Airtouch boasts a number of potentially useful features that could enable high-volume screening: It’s lightweight at 5.5 lb and handheld. The high-performance battery charges within two […]
Genetesis completes $9.2m Series B
Cardiac imaging technology developer Genetesis announced today that it completed a Series B financing round worth $9.2 million. Significant investments from TDK Ventures and an undisclosed Fortune 500 company helped to complete the funding, according to a news release. Returning investors CincyTech, Ohio Innovation Fund and Mark Cuban also contributed. Mason, Ohio-based Genetesis develops the […]
Activ Surgical launches robotic surgery AI software
Activ Surgical said today it is launching ActivEdge, an artificial-intelligence and machine-learning platform designed to improve surgical procedures and outcomes. The Boston-based company said it will be available initially in the U.S. and next year worldwide. Activ Surgical said it will initially focus on promoting the new software for the most common laparoscopic procedures, including […]
Ambu to launch single-use endoscopy device
Ambu announced today that it will launch its Ambu aView 2 Advance display unit for use with endoscopes in Europe and the U.S. Denmark-based Ambu received CE Mark and FDA approval to market its portable, full-HD unit that combines with single-use endoscopes across multiple clinical areas. The Ambu aView 2 Advance connects with Ambu’s aScope […]
Vascular Solutions recall of Langston dual lumen catheter is Class I
The FDA issued a notice today warning that its recall of the Vascular Solutions Langston dual lumen catheter is identified as Class I, the most serious kind of recall. Vascular Solutions, a Teleflex (NYSE:TFX) subsidiary, designed the Langston dual lumen catheter for the rapid delivery of dye into blood vessels during medical imaging tests, allowing physicians to […]