The U.S. FDA has greenlighted two new modules for Siemens Healthineers’ AI-Rad Companion platform, giving radiologists new artificial intelligence (AI) tools to assist in interpreting magnetic resonance imaging (MRI) studies of the brain and prostate. The AI-Rad Companion Brain MR for Morphometry Analysis and AI-Rad Companion Prostate MR for Biopsy Support join earlier intelligent software modules for Chest CT.

Thermo Fisher Scientific Inc. released updated software and new instructions for its Taqpath COVID-19 Combo Kit, a widely used COVID-19 test kit that is also the basis for several other coronavirus diagnostics, following issuance of a letter to clinical laboratory staff and health care providers by the U.S. FDA about the risk of false results with the test. Separately, the Waltham, Mass.-based company has released the first in a series of hematology-oncology assays designed to run on its Ion Torrent Genexus system.

PARIS – Integragen SA and OncoDNA SA have signed a tender offer agreement anticipating a takeover bid. Gosselies, Belgium-based OncoDNA will purchase 100% of the shares of Integragen, floated on the Euronext Paris Euronext Growth Markets, at a unit price of $2.60, valuing the latter’s share capital at $17.2 million.

Cryoablation technology firm Icecure Medical Ltd. raised $6 million (₪20.7 million) in an oversubscribed equity offering. The Caesarea, Israel-based company (TASE:ICCM) plans to use the funds for continued expansion of operations in the U.S., Europe and Asia.

The U.S. FDA revealed good news for Guardant Health Inc. Specifically, the agency has given a thumbs up for Guardant360 CDx for tumor mutation profiling, also known as comprehensive genomic profiling (CGP), in patients with any solid malignant neoplasm. The Redwood City, Calif.-based company noted that this marked the first approval to combine next-generation sequencing (NGS) and liquid biopsy in one diagnostic test to guide treatment decisions. The assay previously was granted a breakthrough device designation.

Investigators at Weill Cornell Medical College have demonstrated that mitochondrial DNA drives the abscopal antitumor response to radiation, which can be boosted by autophagy inhibition.

In what one analyst labeled as a “summer surprise,” Varian Medical Systems Inc. and Siemens Healthineers AG said they plan to combine in an all-cash transaction valued at $16.4 billion. Varian’s board has backed the agreement, which will see Siemens Healthineers pick up all outstanding shares for $177.50 per share in cash, representing a premium of about 42% to the 30-day volume weighted average closing price of Varian's common stock as of July 31. The transaction is expected to close in the first half of calendar year 2021.

CAPS Medical, of Netanya, Israel, closed a $3.5 million series A round led by Chasing Value Asset Management and the Los Angeles-based Israel Investment Fund Group. The new funds will be used to enable CAPS to undertake its first clinical trial for its minimally invasive, nonthermal plasma device for cancer treatment and further develop its portfolio for the treatment of solid tumors.

Liquid biopsy startup Thrive Earlier Detection Corp. has raised $257 million in a series B round led by Casdin Capital and Section 32. The funds will be used to finalize the design of its first product, Cancerseek, conduct a trial to support U.S. FDA approval and prepare for commercialization.