Innoblative Designs announced today that it received FDA investigational device exemption (IDE) for its Sira RFA electrosurgical device. Chicago-based Innoblative Designs’ SIRA device holds FDA breakthrough device designation. It designed SIRA for use in breast cancer patients undergoing breast-conservation surgery (BCS/lumpectomy). SIRA uses radiofrequency ablation (RFA) through a unique spherical shape that circumferentially delivers RF energy. […]
Oncology
Zeiss wins FDA nod for robotic-assisted radiation tech
Zeiss Medical Technology announced today that it received FDA 510(k) clearance for the Intrabeam 700 platform. Intrabeam 700 delivers robotic-assisted precision to support intraoperative radiation therapy (IORT). It features modern, digital-first architecture to create smart workflow efficiency. With seamless connectivity, the platform adds value in neurooncology and breast cancer therapy. The platform features cutting-edge maneuverability, providing […]
Philips, Ibex expand partnership for AI-enabled pathology workflows
Royal Philips today announced the expansion of its partnership with Ibex Medical Analytics and the release of its latest Philips IntelliSite Pathology Solution (PIPS). The Dutch medtech giant says it seeks to accelerate the adoption of AI-enabled digital pathology. The goal is to help health providers address the global shortage of pathologists and the growing […]
GE HealthCare launches AI-driven breast cancer detection tech
GE HealthCare announced today that it launched its Invenia automated breast ultrasound (ABUS) premium offering. The company’s latest 3D ultrasound offering includes advanced AI and other innovative features. It aims to drive faster, reproducible supplemental screening and streamline exam readings on patients with dense breasts. GE HealthCare announced the new offering at the same time […]
Elekta says its CEO is stepping down
Elekta President and CEO Gustaf Salford will step down after the company’s board advised that it was time for new leadership at the Swedish precision radiation therapy devices and software maker. “Although Elekta’s interim results for Q3 did not meet our expectations, there were positive highlights, for instance, in terms of order growth driven by […]
Plexāā secures manufacturing deal for breast cancer surgery prep device
Plexāā recently announced a new partnership with Panasonic Manufacturing UK as their contract manufacturer for the Bloom device. The company says the Bloom platform helps patients prepare for breast cancer surgery and reconstruction by using supraphysiological preconditioning. This technique intermittently heats the skin causing the release of heat-shock proteins that cause vasodilation and increased blood […]
Symphony Robotics licenses surgical robot tech for treating brain tumors
Symphony Robotics announced today that it licensed micro-robotic arm technology from Case Western Reserve University (CWRU). Cleveland-based Symphony Robotics licensed CWRU’s novel, MRI-guided, magnetically actuated robotic platform. The technology navigates non-linear trajectories, enabling precise, micro-invasive surgeries with real-time guidance. The company plans to advance the technology that combines micro-robotic arms, real-time computer vision and state-of-the-art […]
RenovoRx prices $12.1M offering
RenovoRx (Nasdaq:RNXT) announced that it priced an underwritten public offering of common stock worth proceeds of $12.1 million. Mountain View, California–based RenovoRx priced more than 11.5 million shares of common stock at $1.05 per share. It expects the proceeds to total approximately $12.1 million before deducting underwriting discounts, commissions and offering expenses. The company plans […]
Rad AI raises $60M in Series C to bring generative AI to radiology
Rad AI today announced that it’s raised a $60 million Series C financing round, valuing the company at $525 million. Transformation Capital led the oversubscribed round, with participation from existing investors Khosla Ventures, World Innovation Lab, UP2398, Kickstart Fund, OCV Partners, Cone Health and others. The Series C raise comes seven months after the San […]
FDA clears Instylla’s Tembo Embolic System
Instylla today said it has won FDA 510(k) clearance for its Tembo Embolic System. Bedford, Massachusetts-based Instylla said the Tembo system is a bioresorbable embolization agent with particles designed for embolization of hypervascular tumors and blood vessels to occlude blood flow in the peripheral vasculature. Those irregularly shaped, dry gelatin particles range in size between 85 […]
GT Medical raises $37M to advance bioresorbable radiation tile
GT Medical Technologies announced today that it completed a $37 million first close of a Series D financing round. The funds support the completion of clinical studies for the Tempe, Arizona-based company’s GammaTile system. That includes the ROADS clinical study evaluating GammaTile for newly diagnosed brain metastases and the GESTALT clinical trial for patients with […]