GE Healthcare (NYSE:GE) said today it won FDA 510(k) clearance for its Signa Premier wide bore 3.0 Tesla magnetic resonance imaging system. The company said the Signa Premier was the result of a 4-year collaboration with the National Football League and research institutions worldwide and integrated technology to aid in the detection of biomarkers for the potential […]
Imaging
7 medtech stories we missed this week: August 4, 2017
From MDCorp inking a European distribution deal to Align Technology’s North Carolina expansion, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. MDCorp inks distribution deal with Smart Endoscope Systems MDCorp announced in a July 31 press release that it has signed a distribution agreement with Smart Endoscope […]
Profound Medical closes $6m Philips Sonalleve MR-HIFU biz buy
Profound Medical (TSX:PRN) said today it closed its $6 million acquisition of Royal Philips (NYSE:PHG) Sonalleve MR-HIFU business. Philips Sonalleve MR-HIFU platform features real-time MR imaging and thermometry alongside high intensity focused ultrasound for incision-free ablation of tissue, Toronto-based Profound Medical said. “This transaction with Philips is truly transformative for Profound, and represents an opportunity for us […]
EDAP submits FDA 510(k) for Ablatherm Fusion HIFU device
Edap (NSDQ:EDAP) said this week it submitted an FDA 510(k) application for its next-gen Ablaterm Fusion device. The Lyon, France-based company’s next-generation Ablatherm Fusion is a robotic high-intensity focused ultrasound device designed to allow urologists to import pre-treatment diagnostic info, including MRI images and 3D biopsy maps, and merge them with live ultrasound images during prostate […]
UPDATE: Aspect Imaging wins FDA 510(k) for Embrace neonatal MRI
Updated to include comment from Aspect Imaging The FDA today granted 510(k) clearance to Aspect Imaging‘s Embrace Neonatal magnetic resonance imaging device, which it touted as the 1st MRI device specifically designed for neonatal brain and head imaging. The Embrace Neonatal MRI system is designed specifically for imaging neonatal heads, and can be used on […]
8 ways 3D printing is making surgery remarkable
3D printing is already making a difference in healthcare: It enables models of organs to train surgeons and educate patients –and improve surgery outcomes. Doctors previously had to examine actual organs with their hands to get a feel for what they need to do surgically. Now, MRIs and 3D printers eliminate the need to put […]
Report: China’s Symbow Medical raises $17m
China’s Symbow Medical reportedly raised $17 million (¥120 million) for the MR-safe surgical navigation platform it’s developing. Huayi Capital led the investment in the Beijing based company, joined by the Chinese government’s National Emerging Industry Guidance Fund, Shandong Buchang Pharmaceuticals Co. and Sangel Capital, the China Money Network reported, citing a Symbow press release. Symbow […]
Philips to acquire TomTec’s imaging software
Royal Philips (NYSE:PHG) said yesterday that it agreed to acquire TomTec Imaging Systems and its intelligent image analysis software for an undisclosed amount. Munich-based TomTec makes multi-modality and vendor-neutral diagnostic and analysis applications for cardiology, radiology and OB/GYN, the Dutch healthcare conglomerate said. Founded in 1990, TomTec employs more than 100 workers in the U.S., Europe and […]
Cardiac imaging dev VerAvanti raises $5m
Previously-stealthy cardiac imaging developer VerAvanti said today it raised $5 million in a recent round of financing to support its Scanning Fiber Endoscope device development. The Redmond, Wash.-based company’s SFE device uses technology licensed from the University of Washington and consists of an imaging station and micro-sized catheter which can take high-quality images inside of […]
EDAP pulls FDA bid for Focal One, plans to resubmit with new data
Edap (NSDQ:EDAP) said today it withdrew the FDA 510(k) application for its next-gen high-intensity focused ultrasound Focal One device designed to treat prostate cancer. The French company said that following “advanced discussions” with the federal watchdog, it plans to submit a new 510(k) application which includes new clinical data. “As mentioned during our last quarterly call, a […]
Philips partners with West Physics for CT radiation dose control program
Royal Philips (NYSE:PHG) said today it is partnering with West Physics to create a turn-key computed tomography radiation dose management program. The companies said that their new partnered radiation dose management program will help health systems comply with new dose management requirements from accrediting regulatory bodies, helping hospitals establish effective radiation safety programs to optimize radiation […]