ABK Biomedical announced today that it received FDA 510(k) clearance for its Easi-Vue embolic microspheres for treating tumors. Halifax, Nova Scotia-based ABK designed its microspheres for treating patients with arteriovenous malformations and hypervascular tumors. Vascular embolization is an effective therapy for addressing symptoms of these conditions. ABK said in a news release that microsphere embolization […]
Radiosurgery
Fresenius Kabi expands compatibility of radio frequency tagged medication
Fresenius Kabi announced today that its portfolio of radio frequency tagged medications is now compatible with an AmerisourceBergen offering. Lake Zurich, Illinois-based Fresenius Kabi’s growing +RFID portfolio now has compatibility with AmerisourceBergen’s medication tray solution for helping hospitals improve medication inventory visibility and tracking using advanced radiofrequency identification (RFID) technology. Get the full story at […]
Boston Scientific warns on some SpaceOAR systems
Boston Scientific (NYSE:BSX) has issued an urgent field safety notice in Europe due to potential issues with its SpaceOAR systems. Marlborough, Massachusetts-based Boston Scientific’s SpaceOAR system is an absorbable polyethylene glycol hydrogel spacer for separating the prostate from the rectal wall during radiation treatment for prostate cancer. The SpaceOAR Vue, the next-generation hydrogel spacer, offers enhanced […]
FDA approves Novocure’s NovoTTF-100LTM plus chemo for mesothelioma
NovoCure (NSDQ:NVCR) announced that it has received FDA approval for its NovoTTF-100L system with chemotherapy for treating a type of mesothelioma. NovoTTF-100L is a non-invasive, antimitotic cancer treatment designed to deliver electric fields at special frequencies to disrupt solid tumor cancer cell division. Approved under a humanitarian device exemption, NovoTTF-100L and pemetrexed plus platinum-based chemotherapyis indicated […]
NovoCure’s Q2 sales top forecast, earnings miss
NovoCure (NSDQ:NVCR) shares are under pressure this morning after the company reported second-quarter losses that exceeded estimates. The British firm’s losses fell -26.7% to -$15.5 million, or -17¢ per share, on sales growth of 60.3% to $61.5 million for the three months ended June 30. Analysts on Wall Street were looking for losses of -16¢ per […]
Varian Medical to pay $1.3B for Sirtex
Varian Medical (NYSE:VAR) yesterday said it agreed to pay nearly $1.3 billion for Australia’s Sirtex Medical (ASX:SRX) and its anti-cancer microspheres. The A$28-per-share offer, which values Sirtex at A$1.59 billion (about $1.28 billion), is slated to close in late May, Palo Alto, Calif.-based Varian said. It’s part of a bid to broaden that company’s oncology portfolio. Sirtex makes […]
Medtech stories we missed this week: Oct. 27, 2017
From RadiaDyne’s FDA expansion to NuVasive launching its new implants, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. FDA expands indications for RadiaDyne’s OARtrac dose monitor RadiaDyne announced in an Oct. 24 press release that it has received additional FDA clearance for its upcoming OARtrac. The OARtrac allows […]
Novocure gains on additional Optune data
Shares in Novocure (NSDQ:NVCR) are on the rise again after the company today cited additional data from a pivotal trial evaluating its Optune device with temozolomide chemotherapy as a treatment for newly-diagnosed glioblastoma. Novocure’s Optune mobile device delivers low-intensity, intermediate frequency, alternating electric fields, called “tumor treating fields” or TTFields, to inhibit cancer cell replication. The […]
Novocure touts long-term analysis of Optune drug-device combo
Novocure (NSDQ: NVCR) touted a long-term analysis of data from a Phase III pivotal trial of its Optune device in combination with temozolomide for the treatment of newly-formed glioblastomas. Survival data for nearly 700 patients confirmed interim results from the trial, 1st published in December 2015 in the Journal of the American Medical Assn. Patients treated […]