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.
Viome Life Sciences Inc. launched its Cancerdetect test for oral and throat cancer, the first in a developing portfolio of tests that use mRNA technology and an artificial intelligence (AI)-driven platform. The saliva-based oral and throat cancer test demonstrated 95% specificity and 90% sensitivity in identifying these notoriously difficult to diagnose malignancies in a recent study.
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.
Perkinelmer Inc. agreed to divest three businesses in a sale to private equity firm New Mountain Capital for $2.45 billion in cash to create a “pure-play, high growth, high margin life sciences and diagnostics company with unique scale,” said Perkinelmer president and CEO Prahlad Singh.
Dyansys Inc. obtained its second greenlight from the FDA this month for its Primary Relief device to alleviate pain following caesarean-section birth. The company received 510(k) clearance for its First Relief system for painful diabetic neuropathy on July 18. Both systems stimulate nerves on the outer surface of the ear using a percutaneous electrical nerve stimulator (PENS) system.
Better Therapeutics Inc. reported that the pivotal trial for its BT-001 prescription digital therapy (PDT) demonstrated significant decreases in hemoglobin A1c at 90 days that improved further at 180 days in participants with type 2 diabetes. The study showed a clear dose-response between greater use of the PDT and improvements in blood glucose levels.
Exo Inc. acquired Medo Dx Pte, an artificial intelligence (AI) developer, to make its point-of-care ultrasound imaging even easier to use. Medo brings two FDA-cleared artificial intelligence algorithms that draw on a library of millions of ultrasound images and health data to expand the settings for ultrasound and the reduce the expertise required for its use. Terms of the deal were not disclosed.
