Auctus Surgical Inc. took another step toward straightening out one of the most vexing problems in pediatric scoliosis with the announcement of FDA breakthrough device designation for its vertebral tethering system. The system offers a non-surgical option to correct spinal curvature without use of fusion or braces and its dynamic magnetic technology enables adjustment as a child grows, avoiding the overcorrection that plagues the only other tethering system currently available.

Continuing its push to streamline the imaging industry from equipment to vertical integration, Nano-x Imaging Ltd. (Nanox) agreed to acquire Zebra Medical Vision Ltd. and signed a letter of intent to buy Usarad Holding Inc. and its related company Medical Diagnostics Web. The timing of the transactions, designed to create an end-to-end radiology solution, was not announced.

Bioventus Inc. reported plans to acquire Misonix Inc. in a cash and stock transaction valued at $518 million, which the companies expect to close in the fourth quarter of 2021. The transaction will create a total addressable market of $15 billion for the combined company across the wound care, orthopedics, lower extremity and neurosurgery market segments.

Polarityte Inc.’s Skinte product met primary and secondary endpoints in a randomized clinical trial evaluating healing of diabetic foot ulcers. Skinte is a human cellular and tissue-based product made from a patient’s own skin. Results from the trial and data from the product’s use from 2017 to 2021 during a period of enforcement discretion by the FDA were used by the company in its filing earlier this week of an investigational new drug application for Skinte.

Access Biologicals LLC brought online newly released seroconversion panels that measure the level of antibodies against SARS-CoV-2 in blood samples, allowing researchers to determine vaccine efficacy. The panels can detect the point when seroconversion occurs and assess the efficacy of a vaccine against new and existing strains of the novel coronavirus. To build the panels, the Vista, Calif.-based company collected blood samples prior to vaccination and after the first and second doses. The plasma was then tested for IgG antibodies to the S1 and S2 spike proteins of the novel coronavirus using enzyme-linked immunosorbent assays (ELISA) and chemiluminescent assays (CLIA).

Researchers from Finland and Italy published a biomarker-based algorithm for the diagnosis of dementia in the journal Diagnostics. The algorithm enables clinicians to distinguish between various neurodegenerative diseases with shared clinical presentations and select appropriate treatment. The algorithm relies primarily on blood biomarker measurements to diagnose the type of dementia much earlier than is possible with the diagnostic tools in use today.

Happify Inc. launched Ensemble, a prescription digital therapy designed to treat patients with major depressive disorder (MDD) or generalized anxiety disorder (GAD). The app joins several others that target both depression and anxiety, including the eponymous apps made by Woebot Health (Woebot Labs Inc.) and Youper Inc., although it is the only one that requires a prescription in the pack.

Vivasure Medical Ltd. has designed a sutureless and absorbable venous vessel closure for use following percutaneous cardiovascular procedures, such as transcatheter mitral valve or tricuspid valve repair or replacement. The Perqseal Blue technology builds on the Galway, Ireland-based company’s Perqseal, which received the CE mark for vascular closure of femoral arteries in 2016.

Cellares Corp. added Poseida Therapeutics Inc. to its expanding early access partnership program (EAPP) for the company's Cell Shuttle, a highly specialized "factory in a box" solution for development of cell therapies. San Diego-based Poseida brings two autologous CAR-T product candidates to the program and joins Pact Pharma Inc. and Fred Hutchinson Cancer Research Center in the EAPP.

Aditxt Technologies Inc. enhanced its immune response test for COVID-19 by adding a high-sensitivity neutralizing antibody quantification. With the expansion, the multidimensional test, Aditxtscore, provides a comprehensive measure of the strength of an individual's immune response to the novel coronavirus.