Augmented reality-based imaging company Augmedics announced that it raised $36 million in an oversubscribed Series C financing round. Having closed a $21 million Series B round eight months ago, Chicago-based Augmedics has raised $63 million to date, according to a news release. The company plans to use the funds to continue commercialization efforts, develop the […]
Imaging
Butterfly Network reports full-year losses, but sales up more than two-thirds
Now a publicly-traded company, Butterfly Network (NYSE:BFLY) reported full-year 2020 results that showed large losses even as sales grew for its whole-body imaging probes. The Guilford, Conn.-based company posted losses of -$162.7 million or -$27.90 per share, on sales of $46.3 million for the full year ended Dec. 31, 2020, for a 63.2% bottom-line slide […]
8 medical device companies that beat the COVID-19 pandemic and prospered
Some medical device businesses not only survived the COVID-19 pandemic but actually thrived — with many producing the medtech needed to fight the coronavirus’s spread. Medical Design & Outsourcing recently analyzed financials for 20 of the largest medical device businesses in the world. Not only was revenue only slightly down for the 20 during 2020, but it was […]
GE Healthcare 2D/3D imaging system wins FDA nod
GE Healthcare has announced FDA 510(k) clearance for a new surgical imaging system capable of 3D and 2D imaging. OEC 3D offers interoperative 3D imaging with precise volumetric images for spine and orthopedic procedures, according to GE Healthcare. It combines the benefits and familiarity of 2D imaging with OEC C-arms, delivering a familiar user experience with […]
FDA clears Optellum AI-based software system for early lung cancer diagnosis
Optellum announced today that it received FDA 510(k) clearance for its Virtual Nodule Clinic for early lung cancer diagnosis. Oxford, England-based Optellum’s product is an AI-powered clinical decision support software system for pulmonologists and radiologists managing patients with nodules (small lesions) in the lungs that could represent early-stage lung cancer, according to a news release. […]
Companies, docs alarmed by proposed 510(k) rollback
Medical associations and device companies have largely come out against a Trump administration proposal to permanently exempt certain medical devices and software from the FDA 510(k) clearance process. HHS used Trump’s waning days in office to propose permanently exempting 83 Class II devices and one unclassified device from the clearance review process. The list includes home ventilators, […]
Boston Scientific wins FDA approval for radioembolization tech
Boston Scientific (NYSE:BSX) announced today that it received FDA approval for its TheraSphere Y-90 glass microspheres. Marlborough, Mass.–based Boston Scientific’s TheraSphere Y-90 glass microspheres were developed to treat those with hepatocellular carcinoma (HCC), according to a news release. Approval for the technology offers further access to the therapy that, until now, has been utilized under […]
GE Healthcare launches handheld ultrasound
GE Healthcare (NYSE:GE) announced that it launched the Vscan Air wireless, pocket-sized ultrasound device. Cleared by FDA in November, Vscan Air is designed to offer clear image quality, whole-body scanning capabilities and an intuitive software platform delivered in a small handheld device, according to a news release. The company debuted the first Vscan color pocket-sized ultrasound […]
10 Minnesota medtech startups you need to know
Medical device startups can use all the help they can get, including from government-sponsored investment funds. In Minnesota, one of the nation’s top three medtech hubs, the state Department of Employment and Economic Development (DEED) has distributed $1.6 million per year since 2019 in innovation grants to tech startups — many of them in the […]
DTW Podcast: Can AI, advanced imaging and robotics ‘democratize’ surgery?
A new generation of digital surgery systems will level surgeons’ playing field — giving them artificial intelligence, robotic tools, and other assistive technologies. In three interviews in this week’s DeviceTalks Weekly Podcast, leaders from Asensus, ActivSurgical and Memic explain how their systems will improve surgeon performance, reduce errors, and deliver the “democratization” of surgical robotics. […]
ControlRad gains clearance for imaging tech to sell to Boston Sci
ControlRad announced today that it received FDA 510(k) clearance to market its ControlRad Select radiation reduction technology. Atlanta-based ControlRad’s technology uses proprietary semi-transparent filters with a user-interface tablet and imaging processing algorithms that are retrofitted onto customers’ existing Siemens Artis zee interventional imaging systems, according to a news release. ControlRad, ahead of its commercialization efforts […]