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, […]
Imaging
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 […]
Philips debuts AI-enhanced imaging platform
Royal Philips (NYSE:PHG) today said it launched its AI-enabled Precise Suite for its Incisive CT platform. The Precise Suite delivers smart workflows from image acquisition through reporting with AI-enabled image reconstruction, automated patient positioning, motion-free cardiac image capture and real-time interventional guidance, according to the company. The artificial intelligence helps streamline and automate workflows to maximize […]
Philips and Disney want to make MRIs easier for children: Here’s how
Royal Philips (NYSE:PHG) announced today that it is teaming up with Disney to test the effects of custom-made animation to create a relaxing atmosphere for young patients. Amsterdam-based Philips will collaborate with The Walt Disney Company EMEA to see how the animation, including specially-made Disney stories within Philips’ Ambient Experience, creates a relaxing atmosphere to improve […]
Philips, DiA partner on AI-based applications for ultrasound
Philips (NYSE: PHG, AEX: PHIA) announced today that it has formed a strategic partnership with DiA Imaging Analysis to incorporate DiA’s AI library of automated solutions with Philips ultrasound. Be’er Sheva, Israel–based DiA’s AI-enabled 2D ultrasound applications have FDA clearance and a CE Mark. The applications are geared toward reducing variability and increasing the efficiency […]
Ambu single-use endoscope wins Frost & Sullivan innovation award
Frost & Sullivan today announced that it awarded Ambu with a 2021 Global New Product Innovation Award. Ambu received the award for its single-use flexible endoscopes that are designed to make the devices safe, affordable and accessible. It has aView and aBox all-in-one video displays that eliminate the traditional video endoscopy tower size and expense to be […]
The top 7 medtech CEO quotes on COVID-19, one year later
The latest earnings season has provided insights into the future of medtech in the COVID-19 landscape and what certain sectors are seeing as vaccines start to roll out. Since the start of the pandemic, 113.1 million COVID-19 cases have been reported worldwide, according to Johns Hopkins University School of Medicine. The U.S. leads the world […]