Know Labs (NYSE:KNW) today shared new data highlighting the use of its non-invasive blood glucose sensor in glycemic status monitoring. The Seattle-based company published its peer-reviewed study in Diabetes Technology & Therapeutics Journal. The published results demonstrated that Know Labs’ proprietary non-invasive radiofrequency (RF) dielectric sensor and trade-secret machine learning (ML) algorithms correctly classified an individual’s glycemic […]
Diagnostics
Abbott wins FDA clearance for its Lingo OTC glucose monitor
Abbott (NYSE: ABT) has secured a 510(k) clearance from the FDA for its over-the-counter Lingo glucose-monitoring biowearable. The clearance came on May 29, according to a listing on the FDA’s website. An Abbott spokesperson said the company was aware of the clearance and would provide more details later. FDA clearance for Abbott’s Lingo comes more […]
Orange Biomed unveils at-home A1c test in the U.S.
Orange Biomed announced today that it commenced a U.S. launch as it looks to fill testing gaps for pre-diabetes and diabetes. Seoul, South Korea–based Orange Biomed operates out of Research Triangle Park, North Carolina in the U.S. The company currently has ongoing studies for its OBM rapid A1c test. It designed the glycated hemoglobin analyzer […]
Researchers tout AI-based diabetes onset prediction method
Scientists at Klick Applied Sciences say they discovered a way to use a continuous glucose monitor (CGM) as a diabetes screening tool. The scientists determined that they can use artificial intelligence (AI) to screen and prevent the chronic health condition. They used machine learning and 12 hours of data from CGMs to determine whether a […]
Dexcom focuses on early diabetes diagnosis as COVID links emerge
New evidence is showing that COVID-19 may increase a person’s risk of diabetes, but it could be years until we know for sure. In the meantime, Dexcom (Nasdaq:DXCM) is getting ready, VP of Global Clinical Initiatives Tomas Walker said. Walker recently spoke with Medical Design & Outsourcing to discuss the San Diego-based diabetes device developer’s proactive approach […]
Labcorp launches at-home collection device for diabetes risk testing
Labcorp (NYSE:LH) announced today that it launched an at-home collection kit that measures HbA1c from a small blood sample. Burlington, North Carolina-based Labcorp’s first-of-its-kind diagnostic offering uses a collection device from Weavr Health and is offered through its Labcorp OnDemand platform. The company said in a news release that it’s the only commercial laboratory to […]
BD ticks up on Street-beating Q4, sets 2022 guidance range
BD (NYSE:BDX) shares rose today on fourth-quarter results that came in ahead of the consensus forecast. The Franklin Lakes, New Jersey-based medtech posted profits of $242 million, or 84¢ per share, on sales of $5.1 billion for the three months ended Sept. 30, 2021, more than doubling its bottom line on sales growth of 7.3%. Get […]
Thermo Fisher Scientific expands corporate leadership team
Thermo Fisher Scientific (NYSE:TMO) announced today that it appointed Dr. Alan Sachs to chief medical officer and Karen E. Nelson to chief scientific officer. Sachs served as Waltham, Mass.-based Thermo Fisher’s CSO since 2016 and will be succeeded by Nelson as he assumes the newly established CMO position at the company. Both will join the […]
Cardinal Health wins new FDA approval for Lymphoseek
Cardinal Health (NYSE:CAH) announced today that the FDA approved its Lymphoseek injection for pediatric use. Dublin, Ohio-based Cardinal Health touts Lymphoseek — acquired from Navidea Biopharmaceuticals (NYSE:NAVB) in November 2016 — as the first and only radiopharmaceutical agent specifically designed for targeted lymphatic mapping and guiding sentinel lymph node biopsies (SLNB). The new indication will expand […]
BlueStar Genomics gains breakthrough nod for pancreatic cancer test
Bluestar Genomics announced today that it received FDA breakthrough device designation for its pancreatic cancer test. San Diego-based Bluestar’s proprietary noninvasive pancreatic cancer detection test is designed for use with patients with new-onset diabetes, according to a news release. The test uses a standard blood draw to assess whether an individual has an abnormal epigenomic […]
