The U.K. government continues to pump money into research projects focusing on the use of artificial intelligence (AI) in health care as it looks to technology to help diagnose and treat patients. It provided £2 million (US$2.5 million) in funding to test innovative ways to tackle cancers with poor survival rates.
Limaca Medical Ltd. received U.S. FDA 510(k) clearance for its Precision for gastrointestinal (GI) endoscopic ultrasound (EUS) biopsy device which the company said allows for faster, more efficient and safer collection of tumor tissue samples. The approval follows the receipt of breakthrough device designation, and the deployment of the device into the U.S. market should lead to more efficient and effective diagnosis of GI cancers.
Nevia Bio Ltd. (formerly Gina Life Ltd.) completed a $3.1 million seed round that will allow the company, which has developed a platform that can decode biomarkers data from vaginal secretions for the early detection of ovarian cancer, to conduct clinical trials. With ovarian cancer the leading cause of death in women diagnosed with gynecological cancers, Nevia is hoping that its platform will save many lives.
Aion Biosystems Inc. may be operating at a fever pitch right now, with FDA 510(k) clearance in hand for the company’s Itempshield device, which provides continuous measurement of body temperature. The company is targeting use of the quarter-sized device for patients with cancer and individuals in long-term care.
Imagion Biosystems Ltd. signed a flurry of deals recently to expand its pioneering molecular magnetic resonance imaging platform Magsense beyond Australia and into additional indications to detect cancer earlier.
Broncus Holding Corp. successfully completed a clinical study of the world’s first transbronchial radiofrequency ablation system for lung cancer treatment.
Delcath Systems Inc. reported that the FDA approved its Hepzato Kit for the treatment of adults with unresectable hepatic-dominant metastatic uveal melanoma (mUM). The FDA nod also triggered a second tranche of financing of approximately $35 million from a private placement in March.
Dermasensor Inc.’s elastic scattering spectroscopy device appears to have solved one of the more challenging issues in dermatology—early detection of skin cancers in individuals with darker skin tones. The device demonstrated very high sensitivity across all skin cancer types compared to histopathological exams with minimal variation between Fitzpatrick skin type groups in an analysis of the DERM-SUCCESS trial.
Enochian Biosciences Inc.changed its name toRenovaro Biosciences Inc. and reported a deal to merge part of the company with Gedi Cube Intl Ltd. in an effort to move on from recent controversies. “Renovaro, Latin for ‘renewal,’ represents our company’s mission,” said Mark Dybul, CEO of the company.
Accuray Inc. offered a classic good news-bad news set-up for investors on Wednesday, with a notable FDA 510(k) clearance balanced by a miss on fourth quarter revenue and projections for fiscal year 2024 significantly below consensus expectations. Still, the takeaway is generally positive, with several strong catalysts expected to build momentum for the company in the coming year and much of the underperformance attributable to foreign exchange headwinds that have plagued many med-tech companies.