New artificial intelligence capabilities will be integrated into widely used genomic testing for breast cancer under a new partnership formed by Agendia Inc. and Paige.ai. The two companies are working together to enhance the genomic information from Agendia's Mammaprint and Blueprint diagnostic tests with AI-based digital diagnostics provided by Paige with the goal of redefining precision oncology.
Following steady expansion of its base among global pharmaceutical companies, Correlia Biosystems Inc. has secured the capital needed to make its nanotechnology-based immunoassay platform commercially available. The company received an infusion of $7 million in series A financing in a round led by Neotribe Ventures with participation by Cota Capital, the Regents of the University of California and others.
The draft version of the U.S. Medicare national coverage analysis for blood-based biomarker tests for colorectal cancer (CRC) engendered a large body of support, but several stakeholders recommended that the Centers for Medicare & Medicaid Services (CMS) avoid prescriptiveness regarding the sensitivity and specificity for any tests that would be covered under the policy.
Medtronic plc reported second quarter worldwide revenue of $7.647 billion, a decrease of 0.8% as reported and 1.5% on an organic basis. Analysts noted, however, that the figure beat the consensus of $7.08 billion. It also exceeded Wells Fargo’s $7.12 billion estimate. With the continued uncertainty related to the ongoing COVID-19 pandemic, the Dublin-based company did not provide formal annual or quarterly financial guidance. Still, the need for ventilators pushed the company ahead.
Endoscopic ultrasound-guided biopsy startup Limaca Medical Ltd. has raised $1.25 million of a $1.5 million round to advance its next-generation Precision device. The company said it will use the funds to complete first-in-human procedures, conduct postmarket clinical studies and gain regulatory approvals of Precision for gastrointestinal (GI) system and adjacent organ tumors.
PARIS – Carmat SA has closed an $11.8 million loan in the form of a government-backed loan from a French banking syndicate. In an environment made uncertain by the COVID-19 crisis, Carmat will be able to continue its clinical development program on its total artificial heart, undisturbed. “This financing facility contributes to securing our cash position and extends our financial visibility through to the third quarter of 2021,” Stéphane Piat, CEO of Carmat, told BioWorld.
Keeping you up to date on recent developments in oncology, including: Nanoparticles may blunt TRIM37’s impact on metastasis in triple-negative breast cancer; Glycolysis inhibition via collateral lethality; Making exceptional responders unexceptional; Protons may spare cancer patients a hit to the heart.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA lists entities recognized under ASCA program.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Apyx Medical, Braid Health, Cardiawave, Cepheid, Fluidigm, Neuronetics, Zymo Research.
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