Swedish precision radiation therapy devices and software maker Elekta is bringing in an executive from Denmark to be its new CEO. Elekta today announced the appointment of Jakob Just-Bomholt, who will take over the corner office at the company on Sept. 1, 2025. Just-Bomholt, a Danish citizen, will be based in Stockholm and will start […]
Radiosurgery/Radiation therapy
Stryker wins FDA clearance for nerve ablation system
Stryker announced today that it received FDA 510(k) clearance for its OptaBlate basivertebral nerve ablation system (OptaBlate BVN). Portage, Michigan–based Stryker designed OptaBlate BVN for a targeted minimally invasive procedure. It aims to provide long-lasting vertebrogenic pain relief. Stryker says adding OptaBlate BVN to its pain portfolio expands its advanced pain therapy solutions for patients. […]
NeuroOne completes FDA submission for nerve ablation tech to treat facial pain
NeuroOne (Nasdaq:NMTC) announced today that it filed an FDA 510(k) submission for its trigeminal nerve ablation technology. The submission comes in ahead of schedule for the Eden Prairie, Minnesota-based company. Just last month, the company earmarked May for the 510(k) clearance submission. Before that, the company projected a submission by the end of June. Trigeminal […]
NeuroOne says tariffs won’t impact business, Zimmer Biomet deal
NeuroOne (Nasdaq:NMTC) CEO Dave Rosa today issued a letter to shareholders outlining the company’s exposure to tariff impact. Tariffs recently announced by the Trump Administration — then paused last week for at least 90 days — have created a stir in the industry. Medtech trade group AdvaMed praised the decision to suspend the tariffs earlier this week, […]
Innoblative wins FDA IDE for electrosurgical device for breast cancer treatment
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. […]
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 […]
Johnson & Johnson has positive dual-energy ablation data
Johnson & Johnson MedTech announced 12-month data from its SmartfIRE clinical trial of the ThermoCool SmartTouch SF catheter. The medtech giant said investigators presented findings at the annual meeting of the European Heart Rhythm Association (EHRA) in Vienna, Austria. Outcomes showed that the dual-energy catheter proved 86.9% effective when treating patients with high adherence to […]
NeuroOne accelerates FDA submission timeline for nerve ablation tech
NeuroOne (Nasdaq:NMTC) announced today that it accelerated the anticipated timeline of the FDA submission for its nerve ablation tech. Eden Prairie, Minnesota–based NeuroOne now expects to submit the trigeminal nerve ablation for FDA 510(k) clearance in May. It previously projected a submission by the end of June. Trigeminal nerve ablation, a minimally invasive procedure, uses […]
Pulnovo Medical raises $100M for artery denervation tech
Pulnovo Medical announced that it closed a Series C funding round worth proceeds of nearly $100 million. Qiming Venture Partners and existing shareholder Lilly Asia Ventures co-led the financing. Existing investors OrbiMed and Gaorong Capital participated on a super pro-rata basis as well. Shanghai-based Pulnovo said the $100 million represents made the round oversubscribed by […]
Biotronik, Egg Medical collaborate to protect healthcare workers from radiation
Biotronik and Egg Medical are partnering to improve radiation protection for interventional healthcare workers. The two companies are collaborating to sell Egg Medical’s EggNest Radiation Protection Systems for healthcare workers in the U.S. The EggNest Systems, which includes EggNest XR, EggNest Protect, and EggNest Complete, can be used in a variety of fluoroscopy procedures without […]
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 […]
