Medical Microinstruments announced today that the FDA granted de novo clearance for its Symani surgical robot platform. Clearance covers soft tissue manipulation to perform microsurgery. This technique involves reconnecting tiny vessels to restore blood flow or redirect fluid during reconstruction or repair. FDA authorization makes Symani the only commercially available platform in the U.S. for […]
Health Technology
Medtronic has positive data for single-shot mapping ablation catheter
Medtronic today announced positive clinical trial data for its Sphere-360 investigational pulsed field ablation (PFA) catheter technology. The single-shot mapping and ablation catheter uses pulsed field energy to treat patients with paroxysmal AFib. Medtronic presented interim findings on the system at the European Heart Rhythm Association (EHRA) 2024 Annual Meeting. Designed with the goal to […]
Boston Scientific begins trial of Faraview PFA software with magnetic nav catheter
Boston Scientific announced today that it began a new study of its Faraview software module for the Farawave pulsed field ablation (PFA) catheter. The NAVIGATE-PF study evaluates Faraview when used to visualize and track the Farawave Nav PFA catheter for treating AFib. Faraview and the Farawave Nav catheter expand the capabilities of the Boston Scientific […]
Clarius, ThinkSono unveil new AI-guided ultrasound tech in Europe
Clarius Mobile Health and ThinkSono announced today that they introduced a new AI-guided ultrasound system in Europe. The companies believe this offering can improve the efficiency of detecting deep vein thrombosis (DVT). ThinkSono Guidance, an AI app, pairs with Clarius handheld ultrasound scanners, which recently received CE mark approval. Clarius also featured on Fast Company’s […]
FundamentalVR, Orbis launch VR surgical training offering for resource-limited settings
Orbis and FundamentalVR today announced the launch of a new immersive VR surgical training solution for low- and middle-income countries. The companies built the tool to support students and residents learning to perform surgery to treat cataracts. They developed it with affordability, portability and scalability in mind, along with targeted functionality. FundamentalVR says it marks […]
Brainlab, Fujifilm partner on neurosurgery navigation tech
Fujifilm Healthcare announced that it picked Brainlab to exclusively distribute its Arietta Precision ultrasound for neurosurgery applications in the U.S. The companies say Arietta Precision in conjunction with Brainlab’s surgical navigation system “becomes a powerful intraoperative neurosurgery solution.” It delivers advanced guidance and image quality for critical surgical decisions. Together, the end-to-end solution provides comprehensive […]
FDA clears new mammography system from Siemens Healthineers
Siemens Healthineers announced today that it received FDA 510(k) clearance for its MammoMat B.brilliant mammography platform. Clearance includes elements involving full-field digital mammography, or two-dimensional breast imaging, breast biopsy and titanium contrast-enhanced mammography. New features of the system enhance user ergonomics and workflow while reducing patient discomfort. Siemens Healthineers also submitted an FDA premarket approval […]
Insulet applauds as UK begins artificial pancreas rollout
Insulet (Nasdaq:PODD) expressed its excitement today as a new diabetes initiative in the UK could bring artificial pancreas’ to many with diabetes. NHS England said tens of thousands of children and adults with type 1 diabetes in the country will receive an artificial pancreas. The initiative includes hybrid closed-loop automated insulin delivery systems like Insulet’s […]
Smiths Medical warns on some infusion pumps
An urgent field safety notice issued in Europe warns of software issues with some CADD-Solis ambulatory infusion pumps made by Smiths Medical. The ICU Medical unit corrected some issues in previous software updates but some problems persist. For starters, according to the communication, the infusion pump may not alarm for an upstream occlusion. This issue […]
Biolinq raises $58M to support intradermal glucose sensor
Biolinq announced today that it completed a $58 million financing to support the progression of its proprietary intradermal glucose sensor. Alpha Wave Ventures led the funding round. Niterra’s corporate venture capital fund jointly operated with Pegasus Tech Ventures also participated. Other contributors included existing investors RiverVest Venture Partners, AXA IM Alts, Global Health Investment Corporation, […]
Neurava raises $2.3M for epilepsy monitoring tech
Neurava announced today that it completed an oversubscribed seed financing round worth proceeds of $2.26 million. Indianapolis-based Neurava develops a novel wearable device for mitigating the risk of sudden unexpected death in epilepsy (SUDEP). The device monitors and alerts for seizures, cardiorespiratory dysfunctions, and the impending risk of SUDEP. Neurava says it’s unlike any other […]