Avatar Medical announced today that its virtual reality (VR) surgical planning technology received FDA 510(k) clearance. Paris, France-based Avatar Medical designed its platform to help surgeons better prepare for procedures through VR representations of patients. Patient “avatars” generate instantly from CT scans or MRI for use with the VR platform. It features underlying technology developed […]
Imaging
FDA clears DeepX Diagnostics teledermatology screening for suspected skin cancer lesions
DeepX Diagnostics announced today that it received FDA clearance for its DermoSight digital dermatoscope. The DermoSight scope is used for teledermatology screening of suspect skin cancer lesions. Washington-based DeepX Diagnostics plans to enter the U.S. market having already completed more than 180,000 assessments in Europe. FDA clearance for DermoSight covers the acquisition of skin lesions […]
Teleflex Arrow EZ-IO needle cleared for use in MRI
Teleflex (NYSE:TFX) announced today that it received FDA 510(k) clearance for its Arrow EZ-IO needle for MR conditional labeling. Wayne, Pennsylvania-based Teleflex said the regulatory nod makes the needle the first and only intraosseous needle with 510(k) clearance. The EZ-IO needle represents a critical component of Teleflex’s Arrow EZ-IO intraosseous vascular access system. It features […]
FDA clears GE Healthcare’s Sonic DL AI tech that speeds up MRI
GE HealthCare (Nasdaq:GEHC) announced today that it launched its now FDA-cleared Sonic DL MRI technology. Chicago-based GE HealthCare developed Sonic DL as a state-of-the-art deep learning-based technology. The company designed it to accelerate image acquisition in magnetic resonance imaging (MRI). This platform could enable new imaging paradigms, including high-quality cardiac MRI in a single heartbeat, […]
Startup Ezra wins FDA clearance for AI that enhances MRIs
Ezra today announced it received FDA 510(k) clearance for its Ezra Flash AI platform that enhances the quality of MR images. New York-based Ezra designed Ezra Flash to reduce the time needed to complete a high-quality scan with the hopes of reducing MRI costs. The company plans to use the technology to launch what it […]
The top cardiac care innovation news at Heart Rhythm 2023
The future of cardiac care was on display at the Heart Rhythm Society’s 2023 annual meeting. Medical device companies showcased groundbreaking technologies at Heart Rhythm 2023, May 19-21 in New Orleans. The innovations presented during the event offer new avenues for diagnosis, treatment, and monitoring of cardiovascular conditions, providing hope for patients worldwide. Boston Scientific, […]
Stryker announces first completed cases with brain surgery guidance platform
Stryker (NYSE:SYK) announced today that surgeons began early product surveillance cases for its Q Guidance system with cranial guidance software. Kalamazoo, Michigan-based Stryker designed the Q Guidance System as an image-based planning and intraoperative platform. The company launched the system for spinal applications in September 2022. This latest iteration offers support for cranial surgeries. Stryker received […]
First U.S. procedure conducted with Noah Medical surgical robot
Noah Medical announced the first use of its Galaxy surgical robot system in the U.S., marking the platform’s commercial release. San Carlos, California-based Noah Medical received FDA clearance for the Galaxy system in March. The system provides bronchoscopic visualization and access. These capabilities provide diagnostic and therapeutic procedures in patient airways. Galaxy features advanced imaging […]
Philips launches AI-powered CT imaging system
Philips (NYSE:PHG) announced that it launched the Philips CT 3500, a new high-throughput CT system powered by artificial intelligence (AI). Amsterdam-based Philips designed the new CT system to target the needs of routine radiology and high-volume screening programs. It features a range of image-reconstruction and workflow-enhancing features to deliver consistency, speed and first-time-right image quality. […]
Hologic turns to Eagles rookie Kelee Ringo and his mom to raise mammograms awareness
Hologic (Nasdaq:HOLX) today announced a new partnership with recently drafted NFL quarterback Kelee Ringo and his mother. The partnership with Ringo and his mother, breast cancer survivor Tralee Hale, aims to provide education around breast health. That includes the importance of prioritizing annual mammograms and other key health screenings. Last month, the Philadelphia Eagles drafted […]
FDA clears AI software for MRSA diagnostics from BD
BD (NYSE:BDX) announced today that it received FDA 510(k) clearance for its new Kiestra imaging application that uses AI. The Kiestra methicillin-resistant staphylococcus aureus (MRSA) imaging application uses AI to interpret bacterial growth and release negative specimens with minimal human interaction. Franklin Lakes, New Jersey-based BD designed the Kiestra MRSA application to utilize AI to […]
