Boston Scientific announced today that it began a limited market release of its VersaVue single-use flexible cystoscope. VersaVue expands the company’s product offerings intended to help clinicians diagnose and treat urinary tract conditions. The scope, which received FDA clearance in October, provides visualization of the lining of the bladder and urethra. It displays images to […]
Imaging
FDA clears Syngo Virtual Cockpit tech from Siemens Healthineers
Siemens Healthineers announced that the FDA cleared its Syngo Virtual Cockpit, a private, secure communication platform. The platform enables real-time image visualization, acquisition and collaboration between healthcare professionals across multiple sites. Siemens Healthineers designed the software so users can connect to CT, MR, PET and a number of other scanners. Scanners include those made by […]
Orthofix partners with MRIguidance on orthopedic imaging
Orthofix Medical announced today that it agreed with MRIguidance to distribute its imaging software in the U.S. The Lewisville, Texas–based company agreed to distribute the BoneMRI software in the U.S. It also announced the successful completion of the world’s first eight cases using BoneMRI with its 7D Flash navigation system. BoneMRI creates a synthetic CT […]
FDA approves expanded MRI labeling for Abbott Proclaim neurostim
Abbott announced today that the FDA approved expanded MRI labeling for its Proclaim DRG neurostimulation system. Proclaim DRG provides targeted relief for people with complex regional pain syndrome (CRPS) types I and II of the lower limbs. It stimulates the dorsal root ganglion (DRG) clusters of nerve cells found along the spine. Abbott says four […]
Clarius wins CE mark for handheld full-body ultrasound tech
Clarius Mobile Health announced today that it received CE mark approval for its wireless handheld whole-body ultrasound scanner. The PAL HD3 scanner combines phased and linear arrays on a single head, providing bedside imaging of superficial and deep anatomy. Vancouver, British Columbia-based Claruis said it made the system available today in Europe and the UK. […]
FDA clears stereotactic guidance system from ClearPoint Neuro
ClearPoint Neuro (Nasdaq:CLPT) announced today that it received FDA 510(k) clearance for its SmartFrame OR stereotactic system. Solana Beach, California–based ClearPoint Neuro developed its SmartFrame OR system with two main components. It features the SmartFrame OR technology with the ClearPointer optical navigation wand. SmartFrame OR offers stereotactic guidance for placing and operating instruments or devices […]
Olympus, Canon Medical partner on endoscopic ultrasound
Canon Medical and Olympus announced that they reached an agreement to collaborate on endoscopic ultrasound technology. Under the agreement, Canon will develop and manufacture diagnostic ultrasound used in endoscopic ultrasonography (EUS). Olympus handles the sales and marketing efforts in the collaboration. The deal utilizes Canon’s Aplio i800 diagnostic EUS ultrasound and Olympus’ ultrasound endoscope. Canon […]
Zeta Surgical wins expanded FDA nod for mixed reality navigation system
Zeta Surgical announced today that the FDA granted it a special 510(k) clearance for expanded software functionality. The Zeta cranial navigation system’s special clearance applies to enhanced software features and compatibility with additional accessories. Zeta Surgical’s mixed reality (MR) system initially received FDA clearance in September. The Zeta cranial navigation system provides surgeons with GPS-like […]
Hyperfine launches AI-powered brain imaging tech
Hyperfine (Nasdaq:HYPR) announced today that it launched the AI-powered eighth generation of its Swoop brain imaging system. The FDA cleared the new software’s diffusion-weighted imaging (DWI) AI denoising feature in October 2023. Hyperfine began rolling it out at select sites over the past several weeks in a limited market release. Swoop’s latest updates enhance its […]
GE HealthCare to acquire AI imaging analysis company MIM Software
GE HealthCare announced today that it agreed to acquire AI and medical imaging analysis provider MIM Software. GE HealthCare plans to fund the acquisition — for which financial terms were not disclosed — with cash on hand. MIM Software provides AI-based software for radiation oncology, molecular radiotherapy, diagnostic imaging and urology. The Cleveland-based company’s offerings […]
FDA clears next-gen handheld ultrasound from Butterfly Network
Butterfly Network (NYSE:BFLY) announced today that it received FDA clearance for its next-generation handheld ultrasound system. BFLY shares were up more than 23% to $1.25 apiece on the news. MassDevice‘s MedTech 100 Index was up more than 1%. The Butterfly iQ3 point-of-care ultrasound (POCUS) system marks the third iteration of the company’s technology. Burlington, Massachusetts- […]