Quantum Surgical SAS has secured CE marking for the expanded use of its Epione robotic platform to treat bone tumors and metastases. The regulatory green light allows surgeons to use Epione to treat inoperable tumors which are difficult to reach due to their size or location at an early stage, in a simple and effective way.
Cyted Health Ltd. raised $44 million in a series B financing round to expand the reach of Endosign, its capsule sponge technology, in the U.S. Endosign is a minimally invasive device used to collect cell samples from the esophagus for the early detection of esophageal diseases, offering the potential to transform early cancer detection and improve health outcomes.
Billiontoone Inc.’s Northstar Select comprehensive genomic profiling liquid biopsy assay identified more treatable variants than other tumor profiling platforms in a study published in The Journal of Liquid Biopsy. Notably, the test found clinically actionable alterations substantially below the limit of detection for other tests.
Novocure GmbH said it submitted a premarket approval application to the U.S. FDA for its Optune Lua wearable device tumor treating fields therapy for the treatment of locally advanced pancreatic cancer.
Better Medicine OÜ raised €1 million (US$1.16 million) in a pre-seed funding round for its AI platform, Bmvision Kidney, which uses deep-learning models to detect malignant kidney lesions. The funds will be used to accelerate the rollout of the software across Europe and prepare for U.S. FDA clearance.
Deephealth Inc., a subsidiary of Radnet Inc., completed the acquisition of breast health solutions company Icad Inc. in a $110 million all-stock transaction. The company also received U.S. FDA 510(k) clearance for Techlive – a remote scanning solution enabling centralized operation and supervision of MR, CT, PET/CT and ultrasound procedures.
A research team from Pusan National University has developed a novel deep learning model coined Moglo-Net, designed to enable three-dimensional reconstruction of images from hand-held ultrasound procedures.
Heartflow Inc. upped the price of shares in its IPO for a second time to $19 on Aug. 7 before opening on the Nasdaq as “HTFL” at $28 and climbing to $31.50 in early trading. The IPO raked in $316.7 million for the 16.67 million shares sold, giving the cardiology company a valuation of $2.27 billion.
Just two days after reporting the appointment of a new CEO, Instylla Inc. said it received a premarket approval from the U.S. FDA for its flagship product Embrace hydrogel embolic system. Embrace HES has been approved for the embolization of hypervascular tumors in peripheral arteries.
A management-led syndicate of prominent investors acquired a majority stake in Histosonics Inc. that values the company at approximately $2.25 billion. The funding will support expansion of the Edison Histotripsy system and therapy platform into new clinical indications and markets. Edison uses non-invasive focused ultrasound energy to destroy tumors.