Esophageal cancer is often referred to as the “silent killer” because few people show any symptoms until after the cancer has spread. If localized, five-year survival rate is 46%, but that drops to just 5% when malignancy has reached distant parts of the body.

The U.S. FDA granted 510(k) clearance to Hyperfine Inc. for improved artificial intelligence (AI)-powered software for its Swoop portable magnetic resonance imaging (MRI) device. The company launched the new software this week.

The U.S. FDA has cleared the way for Seastar Medical Holding Corp.. to conduct a pivotal IDE study of its Selective Cytopheretic Device (SCD) in adults with acute kidney injury (AKI). The Denver-based company plans to begin enrolling patients as early as next month.

Complete Genomics Inc. launched a new line of genetic sequencers designed to decode DNA in greater quantities – and at a lower price point – than existing sequencing tools. The new products could signal a new era of more affordable testing, leading to wider availability and the potential to fulfill the long-desired promise of precision medicine.

Epigenetic testing company Trudiagnostic LLC has linked up with Rejuve.AI, an artificial intelligence (AI)-powered longevity research network, to develop more accurate tools for predicting chronological age. Specifically, the collaboration seeks to shed new light on the biology of aging and connectedness of DNA methylation (DNAm), metabolomics and proteomics.

Baxter International Inc. has joined forces with Miromatrix Medical Inc. to advance the development of bioengineered organs for patients with acute liver failure (ALF). Under the collaborative research agreement, Baxter will combine its Prismax system with Miromatrix's single-use bioengineered liver, miroliver, to provide external support to patients' native livers as they await transplant or potential regeneration.

Bioelectronic medicine startup Setpoint Medical Corp. raised $80 million in a preferred stock financing co-led by new investors Norwest Venture Partners and Viking Global Investors. The company has also secured a line of credit for up to $65 million, bringing total access to capital to up to $145 million.

Diagnostics startup Geneoscopy Inc. said Tuesday it has completed a PMA submission for its noninvasive, stool-based, at-home screening test for the detection of colorectal cancer (CRC) and advanced adenomas (AA) in average-risk individuals. The filing is based on positive results from the company’s pivotal CRC-PREVENT trial that met all primary outcome targets, including sensitivity and specificity for CRC and AA.

The U.S. FDA has given the green light to Abbott Laboratories Inc. for its Navitor next-generation transcatheter aortic valve implantation (TAVI) system for the treatment of patients with aortic valve stenosis who are at increased risk of open-heart surgery. Abbott won European approval of Navitor in May 2021.