South Korean medical software firm Coreline Soft Co. Ltd. said it gained U.S. FDA 510(k) clearance for its artificial intelligence-based coronary artery calcification assessing solution, Aview CAC, while raising ₩18 billion (US$13.33 million) in a private placement.
Exact Sciences Corp. reported on data showing high sensitivity and specificity for the non-endoscopic Oncoguard Esophagus test that is currently in development for the detection of esophageal adenocarcinoma (EAC) and its precursors, including Barrett’s esophagus.
An advocate general (AG) for the E.U. Court of Justice did not mince words in calling out the European Commission for its “very significant extension of the scope of the Merger Regulation and of the commission’s jurisdiction” in reviewing Illumina Inc.’s $7.1 billion acquisition of Grail LLC.
Surgeon, CEO and founder of Hutom Corp., Woo Jin Hyung, is working to level the playing field in the operating room with artificial intelligence (AI) and big data, leveraging digital technology to optimize surgical outcomes.
The U.K. National Institute for Health and Care Excellence (NICE) has released a preliminary health technology assessment for three modules of the Proknow series of software systems by Stockholm-based Elekta AB, which may improve the delivery of radiotherapy services across the U.K. However, NICE indicated it wants to see more evidence regarding the impact of these software modules on radiotherapy treatment plans.
Medical Korea 2024 opened to a large audience in Seoul, South Korea for a two-day run to highlight advances in the medical field, including those in radiotherapy.
The U.S. National Institutes of Health reported the launch of a network for clinical trials that will examine the utility of cancer screening tools, which will start with a pilot study of multi-cancer detection (MCD) tests.
Vessi Medical Ltd. recently closed a series A financing round at $16.5 million for the advancement of its cryotherapy technology to treat non-muscle invasive bladder cancer (NMIBC). Vessi believes that its minimally invasive device can provide a therapeutic alternative to a transurethral resection of bladder tumor (TURBT) procedure, the current first line therapy to treat the disease.
If Freenome Holdings Inc.’s $254 million funding round is a sign, the capital markets for med-tech may finally be thawing. The cancer diagnostics company’s latest cash infusion brings its total funds raised to date to more than $1.3 billion. Freenome co-founder and Chief Product Officer Riley Ennis told BioWorld the company’s success in raising cash in a challenging market was attributable to the “perfect storm of huge unmet need and the opportunity that we have, given the treatment advancements.”
Cyted Ltd. received U.S. FDA 510(k) clearance for its Endosign capsule technology, a non-endoscopic capsule sponge device used to collect pan-esophageal samples to detect esophageal pre-cancer and other conditions. The company believes that the minimally invasive test will be able to help prevent deaths from esophageal cancer when offered as a screening test to people on long-term medication for heartburn.