Zavation Medical Products LLC received FDA 510(k) clearance for its Varisync cervical intervertebral body fusion device. Varisync’s plate and spacer components can be used together or paired separately with other components in the company’s cervical spine portfolio. The clearance follows the release Aug. 10 of in vitro and in vivo results of Zavation’s Labyrinth porous interbody device.

Patients with chronic obstructive pulmonary disease (COPD) may soon have a new way to better manage their health without increasing doctor visits. Nuvoair AB reported that a trial in two U.S. locations showed that 80% of participants with COPD experienced a reduction in hospitalizations as well as improvement in quality of life using the company's integrated digital app and counseling program.

Boston Scientific Corp. acquired privately held Obisidio Inc., adding the company’s gel embolic material (GEM) technology to its portfolio. GEM is a ready-to-use, semi-solid material that conforms to the vasculature in which it is placed to immediately obstruct or reduce blood flow to a tumor or abnormality or stop hemorrhaging.

Guardant Health Inc. tripled the number of cancers that can be monitored for minimal residual disease (MRD) or risk of recurrence using its Reveal liquid biopsy, adding breast and lung cancers. The test is currently used to detect circulating tumor DNA in blood for patients treated for stage II or III colorectal cancer (CRC).

Becton, Dickinson and Co. and Accelerate Diagnostics Inc. joined forces to knock out sepsis and put patients on the path to recovery in hours, not days.

With the launch of the Mawi Heart Patch in the U.S., physicians and patients have a lightweight, wireless heart monitoring system that provides seven days of cardiac information. Using a disposable two-lead system affixed to the chest, the device provides a detailed report within 24 hours and can reduce time to diagnosis by 97%, Mawi Inc. said.

Recent U.S. FDA actions could transform decades of prostate cancer care. Two companies focused on prostate cancer received good news from the FDA for their artificial intelligence (AI)-driven software. Bot Image Inc. gained FDA clearance for its medical device computer-aided detection and diagnostic tool, Prostatid. The agency also provided FDA investigational device exemption for Avenda Health Inc.’s Focalpoint ablation system that enables more accurate mapping of a patient’s prostate cancer for better surgical results.

Sengine Precision Medicine Inc. boosted its total fundraising to $19 million with the recent closing of a $10 million series A2 led by the Washington Research Foundation with support from Alethea Fulcrum Fund, Vincere Capital Biotech LLC, Bangarang Group and others. The A2 follows on an earlier $5 million raised in the original series A. Sengine’s Paris Test predicts drug responses using a patient’s cancer cells to grow a tumor organoid that replicates the functionality and genomic characteristics of the original tumor, enabling hyper-personalization of cancer treatment.

A rash of recent announcements in the diabetes market speak to the brisk pace of developments and keen competition in the field. Dexcom Inc. reported good news in the U.K. and Europe, offset by delays in the U.S., while Insulet Corp. gave investors assurance that it was moving full speed ahead in the release of its Omnipod artificial pancreas system. On the pharma side, Arecor Therapeutics plc signed a contingent agreement to acquire Tetris Pharma Ltd. and commercialize Ogluo in the U.K., E.U. and other countries.