The FDA has approved Roche AG’s Ventana MMR Rxdx panel for patients with advanced or recurrent endometrial cancer. The companion diagnostic is the first to identify patients who are eligible for treatment with Glaxosmithkline plc’s (GSK’s) Jemperli (dostarlimab-gxly) monotherapy. The PD-1 antibody immunotherapy received FDA approval on Thursday.
TORONTO – Perimeter Medical Imaging Inc. has been awarded an FDA breakthrough device designation for a machine learning medical platform it said drives ultra-high-resolution, real-time imaging of breast cancer. Data collected from multiple pathology labs in Texas this past year were fed through the optical coherence tomography (OCT) imaging system which now is at the stage where its Imgassist artificial intelligence (AI)-based algorithms can be tested.
Koelis SAS reported the first successful procedures for its platform in 3D fusion imaging-guided focal ablation of prostate cancer at the Clinique Nantes Atlantis in Saint-Herblain, France. These first procedures take place against the background of a multicenter prospective clinical trial starting on the Koelis platform. This includes eight European urology centers, of which six are in France, with data being stored in a dedicated registry.
Lumicks BV raised $93 million in a series D financing led by new investors Farallon Capital Management and Lauxera Capital Partners. The proceeds are earmarked for expansion of the Lumicks’ product pipeline and for commercialization of its Z-Movi cell avidity analyzer.
Organoids cultured from patient-derived colorectal cancer cells have been used to demonstrate for the first time that tumors which have developed resistance to the full range of existing treatments, across chemotherapies, targeted therapies and immunotherapies, retain a requirement for Werner helicase (WRN) for survival. WRN has a key role in the maintenance of genome stability, but although loss of WRN is known to initiate synthetic lethality in DNA mismatch repair deficient colorectal cancer, studies into the effect of inhibiting that helicase have to date been limited to a handful of cell lines.
Just six weeks after receiving FDA 510(k) clearance for its optical coherence tomography (OCT) imaging system (v2.1), Perimeter Medical Imaging AI Inc. received breakthrough device designation from the FDA for its next-gen product, the OCT imaging system with integrated artificial intelligence (AI).
Anyone who has had a malignant tumor removed knows the anxiety that follows. Did any traces of cancer remain, and if it returns, will doctors catch it before it’s too late? To reduce the uncertainty and improve patient outcomes, C2i Genomics Inc. has raised a $100 million series B funding round led by Casdin Capital to advance software that is 100 times more sensitive in detecting residual disease than legacy technologies.
PARIS – Roche SAS, the French division of Swiss pharmaceuticals manufacturer Roche Holding AG, has signed a partnership with Unicancer that brings together all the cancer centers in France. They have created Oncodatahub (ODH), the first real-world cancer data platform in France. This makes a set of quality, longitudinal data representative of cancer patient care in France available to all those involved in the health care ecosystem.
Cosmo Artificial Intelligence Ltd. received the FDA’s nod for its GI Genius intelligent endoscopy system. The device – the first of its kind, according to the agency – uses artificial intelligence (AI)-based on machine learning to improve the detection of lesions during colonoscopy. It will be rolled out in the U.S. by Medtronic plc, which has exclusive worldwide distribution rights.
HONG KONG – Coreline Soft Co. Ltd. has taken its first step into the Greater China market after receiving approval from Taiwan’s Food and Drug Administration (TFDA) on April 8 for its Aview suite of artificial intelligence (AI) medical solutions.