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 […]
Imaging
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- […]
SimBioSys wins FDA nod for TumorSight precision medicine platform
SimBioSys announced that it received FDA 510(k) clearance for its TumorSight cloud-based digital precision medicine platform. FDA clearance came just days after the company inked a partnership with Mayo Clinic to develop precision medicine solutions. The TumorSight platform takes a patient’s standard-of-care imaging to build a custom 3D model of their tumor. The tool provides […]
EndoQuest Robotics, Omnivision partner on surgical robotic visualization
EndoQuest Robotics and Omnivision today announced a partnership to integrate image sensor technology into surgical robotics. Omnivision develops semiconductor solutions, including advanced digital imaging and touch display technology. The companies plan to integrate Omnivision’s CameraCubeChip into EndoQuest’s flexible surgical robotic system. Houston-based EndoQuest designed its system to address unmet needs in gastrointestinal and other endoluminal […]
FDA clears new MR scanner from Siemens Healthineers
Siemens Healthineers announced today that the FDA cleared its Magnetom Cima.X 3 Tesla (3T) magnetic resonance imaging whole-body scanner. Magnetom Cima.X includes the strongest-ever gradients system for a clinically released whole-body MR scanner, according to a news release. This makes smaller structures in the body visible and captures images faster than previous MR scanners. Other […]
SimBioSys, Mayo Clinic partner on AI-powered tech for breast cancer patients
SimBioSys announced today that it entered into a strategic collaboration with Mayo Clinic to develop digital precision medicine solutions. The collaboration aims to develop cloud-based clinical software to support end-to-end decision-making for early-stage breast cancer patients. This includes individualized surgical planning, treatment, drug selection and risk stratification. As part of the collaboration, SimBioSys has had […]
FDA clears novel endoscopic ultrasound tech from EndoSound
EndoSound announced today that it received FDA 510(k) clearance for its EndoSound Vision System (EVS). Portland, Oregon-based EndoSound designed the EVS endoscopic ultrasound (EUS) device to attach to upper gastrointestinal endoscopes. It easily integrates to any endoscopy center’s existing ecosystem and provides access to both imaging and a therapeutic procedure. EndoSound believes the EVS could […]