Royal Philips (NYSE:PHG) said today that it won 510(k) clearance from the FDA for its ElastQ imaging technology, which allows for simultaneous imaging and assessment of tissue stiffness to diagnose liver conditions such as hepatitis B and cirrhosis. The company’s technology uses shear wave elastography to focus sound waves and assess soft tissue stiffness, according […]
Ultrasound
Health Canada approves Fujifilm’s Vevo HD ultra-high-frequency ultrasound device
Fujifilm Sonosite Inc. subsidiary Fujifilm VisualSonics Inc. said today that it won approval from Health Canada for its Vevo Med ultra-high-frequency clinical ultrasound device. The device operates at frequencies that are higher than conventional ultrasound devices, enabling healthcare professionals to see sonograms with image resolution down to 30 micrometers. “Throughout its history, Fujifilm has been […]
Bracco Diagnostics wins another FDA nod for Lumason microspheres
Bracco Imaging U.S. subsidiary Bracco Diagnostics said today that it won FDA approval for its Lumason microsphere contrast agent to be used in ultrasonography of the urinary tract in pediatric patients with suspected or known vesicoureteral reflux. “The approval of Lumason for voiding ultrasonography answers an unmet medical need for an effective imaging study to […]
FDA clears next-gen Sonablate prostate device from SonaCare
SonaCare Medical said today that it won 510(k) approval from the FDA for the latest version of its high intensity focused ultrasound prostate tissue ablation device. The Sonablate device was the 1st of its kind to receive regulatory approval for the focused ablation of prostate tissue, according to SonaCare. The next-gen version features a tool […]
NanoVibronix lands Health Canada nod for patch-based wound healing device
NanoVibronix (NSDQ:NVBXU) said today that it won approval from Health Canada to sell its WoundShield device in Canada. The Elmsford, N.Y.-based company has also won CE mark approval for the device in the European Union. The WoundShield system is a patch-based ultrasound device that increases local capillary perfusion and tissue oxygenation to facilitate soft tissue […]
Clarius wins FDA 510(k) for wireless ultrasound device
Mobile ultrasound developer Clarius Mobile Health said today it won FDA 510(k) clearance for its C3 and L7 Clarius wireless ultrasound scanners. Clarius’ C3 multipurpose ultrasound scanner is designed to image the abdomen and lungs, with an incorporated virtual phased array for heart scans, while the L7 is designed for guiding procedures and imaging superficial […]
Konica Minolta, Mindray ink deal for portable musculoskeletal ultrasound
Konica Minolta (TYO:4902) said today that it inked a partnership with Mindray Medical to bring musculoskeletal portable ultrasound solutions to the market. Wayne, N.J.-based Konica Minolta said that the deal will help the company continue to develop solutions for specialists to deliver the best care possible with cutting-edge ultrasound tech in out-of-hospital settings. “The unique relationship with […]
3D-printed device controls ultrasound waves for surgical procedures
Researchers from Nanyang Technological University in Singapore developed a 3D-printed device that harnesses high-pressure ultrasound to move, manipulate or destroy tiny objects. By controlling these photo-acoustic waves, the device could be useful for performing precise surgery, according to a study published in Applied Physics Letters. “The advantage of acoustics is that it’s noninvasive,” principal investigator […]
Bioventus launches Exogen ultrasound bone treatment in Saudi Arabia
Bioventus said today it launched the Exogen ultrasound bone healing system in Saudi Arabia. The Durham, N.C.-based company’s Exogen is designed to use low-intensity pulsed ultrasound to “help stimulate the body’s natural healing process.” Bioventus touts an 86% healing rate for fractures not healing on their own and 38% faster healing of fresh fractures with […]
Novuson Surgical wins $1.5m NIH grant
Spun-out med device firm Novuson Surgical said today it won $1.47m through a Phase 2 SBIR grant from the National Institute of Health’s National Heart, Lung and Blood Institute. Money came as part of a program to develop a novel approach to mitigating the effects of perioperative bleeding in surgically reconstructed great vessels in neonates through the […]
Insightec touts near 50% tremor score improvement in pivotal Exablate Neuro study
Insightec today touted results from a pivotal study of its Exablate Neuro system, which met its primary endpoint with patients treated with the system reporting a 47% improvement in a composite tremor score at 3 months. Data from the study were published today in the New England Journal of Medicine. “MRI imaging and thermometry provide a high level […]