The latest global regulatory news, changes and updates affecting medical devices and technologies, including: AHRQ: Patient portals underused in ED visits; Butterfly IQ scores well on cost, but supporting data limited.
HONG KONG – Vuno Inc. saw its shares soar on their first day of trading on the Kosdaq board with a $33.4 million IPO. The shares closed at ₩32,150 (US$28.89) on Feb. 26. Vuno had priced the 1.8 million new shares on offer at ₩21,000, exceeding its desired range of ₩15,000 to ₩19,500 and raising ₩37.8 billion, or $33.4 million, to boot.
The U.S. FDA has given a green light to Brainlab AG for two new additions to its robotic surgery systems. The agency granted 510(k) clearances for the Loop-X mobile imaging robot and the Cirq Robotic Alignment module for spine procedures, paving the way for U.S. market entry.
Last year, artificial intelligence (AI)-focused Caption Health Inc. won the U.S. FDA’s nod for software that guides untrained clinicians step-by-step in providing a cardiac ultrasound exam, a process normally performed by a highly skilled specialist. Now, the Brisbane, Calif.-based company has published data showing nurses without prior ultrasound experience who used Caption Guidance software captured ultrasound images of diagnostic quality to assess known cardiac conditions.
PERTH, Australia – Micro-X Ltd. completed an AU$30.5 million (US$23.27 million) placement to expand its U.S. footprint for its lightweight digital mobile X-ray systems. The funds raised will drive market expansion of Adelaide, Australia-based Micro-X’s Rover digital mobile X-ray system that is designed for deployed military medical facilities, and to scale up its Carestream DRX Revolution Nano, a mobile lightweight digital X-ray system for hospitals.
Spectrawave Inc. has scooped up $13.2 million in a series A-2 financing led by prior investor Deerfield Management. The funds will be used to complete development and regulatory filing for its flagship cardiac imaging technology. Prior unnamed seed investors also participated in the round. With this latest infusion, Spectrawave has raised a total of approximately $30 million to date.
LONDON – The U.K. National Institute for Health and Care Excellence (NICE) has published new advice on how and when artificial intelligence (AI) could be applied to the interpretation of mammograms and chest computer tomography images, in a move that is intended to set the ground rules for the uptake of these technologies. In population breast screening, NICE looked at how five AI systems could be used to pick out mammography images that need further assessment, supporting qualified radiologists in their interpretation.
TORONTO – Calgary-based Circle Cardiovascular Imaging Inc. is receiving CA$2.65 million (US$2.09 million) in funding from the Canadian government’s Western Diversification Program (WDP), which represents nearly half of the more than CA$5.5 million (US$3.35 million) investment made to four Alberta-based organizations and companies. Company CEO Greg Ogrodnick attributes this to Circle Cardiovascular’s position “as the world leader in cardiovascular imaging.”
Longeviti Neuro Solutions LLC has received the U.S. FDA’s nod for use of its Clearfit cranial implant with postoperative ultrasound imaging. The expanded 510(k) clearance could help in reducing radiation exposure linked to other post-neurosurgical imaging modalities. Research has shown that current methods of post-neurosurgical imaging put patients at risk of radiation exposure, and that an estimated 29,000 future cancers could be linked to CT scan used in the U.S. each year. Comprised of polymethyl-methacrylate (PMMA), Clearfit is a neuro-reconstructive implant that surgeons use to reconstruct a patient’s cranium following brain surgery.
One in five breast cancer conserving surgeries leaves behind some of the tumor. That means patients must schedule a second surgery and then endure additional pain, infection risk, recovery time and cost. Cairnsurgical Inc.'s Breast Cancer Locator system may change that by providing 3D tools that enable surgeons to precisely tailor resection to the shape, size and location of each tumor.