TORONTO – Exact Imaging Inc. has secured C$5.1 million (US$4 million) from the Business Development Bank of Canada and federal Export Development Canada to drive adoption of its Exactvu micro-imaging platform for real-time imaging of the prostate. Company CEO Randy Aucoin said it’s been a slow process getting street cred for his prostate imager, investing “tens of millions of dollars” in a direct sales force that eventually installed 100 systems in the U.S., Europe and Canada.
PERTH, Australia – Ferronova Ltd. has developed an injectable magnetic and fluorescent tracer that can map the spread of cancer in the lymph nodes more accurately for improving the staging of complex cancers. The polymer-coated iron oxide nanoparticles show more detailed assessment of sentinel lymph nodes and detect micro-metastasis and isolated tumor cells that would otherwise not be detected.
Thirteen months after establishing a strategic alliance to distribute 7D Surgical Inc.’s machine-vision, image-guided surgery platform, Seaspine Holdings Corp. (NASDAQ:SPNE) signed an agreement to acquire the Toronto-based company. 7D Surgical shareholders will receive $27.5 million in cash plus $82.5 million in Seaspine stock and will hold approximately 13% of Seaspine’s shares at completion. The deal is expected to close in the second quarter of 2021.
Medi-Scan Inc. has emerged from stealth mode with cloud-based software that converts the data on ultrasound analog 2D grayscale images into a digital 3D high-definition (HD) format in less than two minutes. The company is currently focusing its efforts on the heart and lungs, with the aim of providing quick, point-of-service evaluation and triaging of patients with heart disease and other conditions, including COVID-19.
Medical device startup Promaxo Inc. has received 510(k) clearance from the U.S. FDA for its office-based MRI system. The portable system is intended for use by urologists and interventional/urologic radiologists who are performing surgical localization of prostatic lesions under Promaxo MRI guidance. It can be used in the office or outpatient surgical setting without the need for significant facility upgrades.
PARIS – Median Technologies SA has unveiled a new clinical development plan for its Ibiopsy platform to provide early diagnosis of lung cancer in at-risk populations using low dose CT scans. Median executives said they hope to demonstrate the potential of deep learning in identifying lung lesions and characterizing them as malignant or benign.
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.