Edap (NSDQ:EDAP) said today that it won 510(k) clearance from the FDA for its Ablatherm, less than a month after a similar device from rival SonaCare won a nod from the federal safety watchdog. The Ablatherm device, like SonaCare’s Sonablate 450, is designed to ablate prostate tissue using high-intensity focused ultrasound. After a years-long dance with the FDA that […]
Radiosurgery/Radiation therapy
ITC grants Varian bid for Elekta investigation
The U.S. International Trade Commission said last week that it will begin an investigation into alleged Tariff Act violations by Elekta (STO:EKTA B), based on a complaint by arch-rival Varian Medical (NYSE:VAR). Varian makes the TruBeam and VitalBeam radiotherapy systems, which compete with Elekta’s Versa HD and Infinity devices. The ITC said Oct. 26 that it would […]
Orfit wins CE Mark, FDA 510(k) for immobilization system
Orfit said today it won FDA 510(k) clearance and CE Mark approval in the European Union for its HP Pro Solution immobilization system for use during proton therapy treatments. The system is designed for use during proton therapy procedures for the brain, head and neck, and can be used with Orfit’s Nanor immobilization masks. “Ensuring […]
Varian Medical wins FDA 510(k), CE Mark for VitalBeam
Varian Medical (NYSE:VAR) said today it won FDA 510(k) clearance and CE Mark approval in the European Union for its VitalBeam radiotherapy system. The VitalBeam system is a modular, high-throughput radiotherapy system which incorporates technology from the company’s TrueBeam radiotherapy system, the Palo Alto, Calif.-based company said. “The VitalBeam system will enable us to complete image-guided […]
NovoCure wins expanded indications for Optune brain tumor-zapping device
NovoCure said it won expanded indications from the FDA and a new CE Mark indication in the European Union for its brain-tumor treating Optune device. The Optune device uses NovoCure’s “tumor treating fields,” which use low-intensity, intermediate-frequency alternating electric fields that limit cancer cell replication and kill cancer cells, the St. Helier, N.J.-based company said. […]
NovoCure prices $165m IPO
NovoCure priced its initial public offering today, saying it looks to raise $165 million by floating 7.5 million shares at $22 a piece. The company said it is also offering a 30-day underwriters option for an additional 1.1 million shares. NovoCure shares are slated to trade on the NASDAQ Global Select Market under the symbol “NVCR”. Last […]
NovoCure sets terms on $206m IPO
NovoCure today set the terms on its forthcoming initial public offering, saying it expects to float 7.5 million shares at $26 to $29 apiece, or $206.3 million at the midpoint of the range. NovoCure said it expects to net about $189 million from the offering, which includes an underwriters allotment for another nearly 1.9 million shares. Earlier this […]
Elekta wins FDA nod for next-gen Gamma Knife
Elekta (STO:EKTA B) said Wednesday it won FDA 510(k) clearance for its next-generation Gamma Knife Icon radiosurgery system. The Icon is Elekta’s 6th generation radiosurgery system, which uses low-intensity radiation as an alternative to traditional brain surgery, the Atlanta, Ga.-based company said. “Leksell Gamma Knife Icon offers a new model for the application of precise radiosurgery for […]
After shelving $69m IPO, Mevion Medical lands $200m, launches China JV
Mevion Medical Systems, which last week shelved plans for a $69 million initial public offering, this week said it raised $200 million from a syndicate of Chinese and U.S. investors and launched a joint venture in the People’s Republic. President & CEO Joe Jachinowski told MassDevice.com today that Mevion, which makes the S250 proton therapy system, […]
ViewRay closes $27m private placement
ViewRay said today it closed a $26.7 million private placement round, floating 5.3 million shares of common stock to support its MRIdian MRI-guided radiation therapy device. The round included investors Aisling Capital, Fidelity, Kearny Venture Partners, Montrose Capital, OrbiMed and Xeraya Capital. Funds from the round will support commercialization of the MRIdian device, research and […]
Accuray, RaySearch ink deal
Accuray (NSDQ:ARAY) said it inked a deal with RaySearch Laboratories to allow Accuray to co-market RaySearch’s RayCare oncology information system in several designated major radiation therapy markets RayCare is designed to handle logistical challenges present in modern radiation therapy centers by using high-performance radiation therapy algorithms, Sunnyvale, Calif.-based Accuray said. “In today’s complex healthcare environment it is […]