Eli Lilly and Co. has the dubious distinction of receiving the first untitled letter in 2022 from the FDA’s Office of Prescription Drug Promotion. The letter, sent Jan. 19 and posted this week, takes the Indianapolis-based company to task for an Instagram ad promoting Lilly’s diabetes drug Trulicity (dulaglutide).

Medtronic plc received FDA premarket approval Friday for use of its Intellis rechargeable and Vanta recharge-free neurostimulators in patients with diabetic peripheral neuropathy (DPN), suddenly tripling the number of spinal cord stimulators approved for the indication. Medtronic’s implantable spinal cord stimulators (SCS) now join Nevro Corp.’s HFX, which has had the distinction since July 2021 of being the only device with FDA approval for DPN, also known as painful diabetic neuropathy (PDN).

With the agreement to purchase Physimax Technologies Ltd. in its rearview mirror, Dariohealth Corp. passes another milestone with its third tuck-in deal in a year. Physimax, a provider of computer vision technology for musculoskeletal (MSK) screening and predictive risk assessment, joins Psyinnovations Inc. (dba Wayforward) and Upright Technologies Ltd. as tuck-ins for the rapidly growing digital health company. The latest deal is by far the smallest. The terms call for the issuance of 256,660 shares of Dariohealth’s common stock, valued at Wednesday’s closing price of $9.65 per share at just under $2.5 million, plus a cash payment of $500,000.

A study by researchers led by David James from the University of Sydney showcases the diversity in metabolic responses observed across different mouse strains exposed to two different diets that demonstrates the heritability of metabolic traits.

Digital health company Connectedhealth Pte. Ltd. launched its Sugosure system to offer care management to type 2 diabetes patients in Singapore. The system is aiming to tackle the “poor management” of type 2 diabetes with technology and to reduce the risk of long-term complications, said Ronald Ling, the CEO of Connectedhealth.

In a recent study, investigators led by Tony Tiganis at Monash University, Australia have identified that upregulation of the enzyme NOX4 (NADPH oxidase 4) boosted levels of reactive oxygen species and protected development of insulin resistance in both aged as well as obese mice.

In a recent study, investigators led by Tony Tiganis at Monash University, Australia have identified that upregulation of the enzyme NOX4 (NADPH oxidase 4) boosted levels of reactive oxygen species and protected development of insulin resistance in both aged as well as obese mice.

Some U.S. FDA warning letters are mostly about documentation, but the key consideration in the widely publicized Dec. 9 FDA warning letter to Dublin-based Medtronic plc seems to be whether Medtronic had a proper understanding of the risk created by malfunctioning infusion pump retainer rings. That difference of opinion regarding risk took a significant bite out of the company’s shares and boosted the fortunes of its rivals in the diabetes space, a cautionary tale regarding the hazards associated with a failure to understand how the FDA sees the risk of device malfunction. The FDA had reported in October 2021 a pair of recalls of Medtronic’s Minimed insulin pumps, although one of the issues cited was related to cybersecurity concerns. The two recalls affected nearly half a million units combined, and could have significantly affect access for some patients.

The U.S. CMS has crafted a payment policy that covers both adjunctive and non-adjunctive continuous glucose monitors (CGMs) in the final rule for durable medical equipment (DME). Medtronic plc, of Dublin, heralded the move as “a very important benefit expansion” for the company’s customers, but the expanded coverage also pays for additional CGMs that work with Medtronic insulin pumps.