The U.S. FDA’s effort to compile a guidance for prescription, point-of-care (POC) blood glucose meter (BGM) test systems seems to show that guidances can be as iterative as the devices they govern. The FDA announcement for the Sept. 28, 2020, final guidance said that the differences between the 2020 final and the 2018 draft include “a minor edit” regarding user accessibility and a technical correction for hemoglobin testing concentration, yielding a document that is finally ready for prime time after four tries over six years.

Abbott Laboratories is celebrating another win with its continuous glucose monitoring (CGM) technology. This time, the company revealed that it has scored the CE mark for its next-generation Freestyle Libre 3 system. Wells Fargo’s Larry Biegelsen noted that the arrival of the CE mark came slightly earlier than his group had expected.

Researchers at the University of Virginia have used a retrospective database analysis to show that the use of nucleoside reverse transcriptase inhibitors for the treatment of HIV or hepatitis B reduced the risk of developing type 2 diabetes by 33%.

Dexcom Inc. has partnered with the University of Virginia (U.Va.) to accelerate development of next generation continuous glucose monitoring (CGM) and automated insulin delivery technology. The five-year agreement will focus on expanding CGM use in type 2 diabetes, gestational diabetes and in-hospital settings.

An Australian study led by University of Melbourne scientists has identified a previously unknown role for the hepatokine, sparc-related modular calcium-binding protein 1 (SMOC1), in suppressing hepatic glucose production. The investigators reported their results in the Sept. 2, 2020, edition of Science Translational Medicine.

Medtronic plc reported first-quarter worldwide revenue of just over $6.5 billion, a decrease of 13% as reported. As Cowen’s Josh Jennings wrote, the company’s results were better than expected, with an organic revenue growth decline of 17% vs. the Street’s prediction of a 25% decrease.

Informed Data Systems Inc. (IDS), doing business as One Drop, scooped up $98.7 million in new financing and commitments to accelerate the expansion of its digital health platform beyond diabetes. The company raised $34.7 million in a series C round led by Bayer AG, of Leverkusen, Germany. Bayer also committed $64 million in development fees and commercial milestones related to a 2019 licensing agreement to leverage the One Drop solution across multiple therapeutic areas.

Two-and-a-half years after regenerative medicine company Mimedx Group Inc. came under federal investigation for improper sales and marketing practices and nearly two years since it was delisted by Nasdaq, the company is back on track financially and pursuing an active pipeline of new products. Marietta, Ga.-based Mimedx recently reported second quarter sales of $61.7 million, a 7.2% decline from the same period the prior year. The second quarter 10Q Form – one of seven SEC financial statements submitted in the last five months as the company worked to regain compliance – brings Mimedx up to date, paving the way for it to relist its stock.

PERTH, Australia – With 1 in 3 patients with type 2 diabetes likely to develop diabetic kidney disease (DKD), Perth-based Proteomics International Laboratories Ltd. has developed a blood-based diagnostic test that can predict the onset of DKD, enabling patients to get treatment sooner to prevent the onset of the disease.