Metabolic

US FDA has greenlighted Senseonics’ Eversense 365 continuous glucose monitor, which must be replaced just once a year. Capable of being integrated with compatible insulin pumps as part of an automated insulin delivery system, the fully implantable device lasts 185 days longer than the Eversense E3 sensor and far outstrips competing CGMs, which last only for 10-14 days.

The Seattle-WA-based company’s latest capital raise follows study results published in July in which Know Labs’ proprietary non-invasive RF dielectric sensor and machine learning algorithms correctly classified participants’ glycemic status as hyperglycemic, normoglycemic, or hypoglycemic with 93.37% accuracy compared with venous blood glucose values. Know Labs' goal is to commercialize a diabetes screening device that could help to funnel undiagnosed patients into the health care system.

This week, Medtronic recalled a nerve monitoring system due to reports of false responses. The US FDA approved the first auto-injector for opioid-overdose, made by Purdue Pharma. The agency granted de novo authorization for Labcorp’s PGDx elio plasma focus Dx used by labs for genetic profiling. As of 7 August, 950 AI/ML devices have been approved by the FDA. EKO Health teamed up with LSU to help detect arrhythmias and murmurs in student-athletes.

Based on clinical evidence to date, including newly released findings in 11 patients at one year post-procedure, Fractyl Health believes that by resurfacing and reversing the pathology of the duodenal lining, its Revita system has the potential to become the first disease-modifying therapy that targets a root cause of obesity and type 2 diabetes.

Medway NHS Foundation Trust joined forces with Digostics to offer home oral glucose tolerance testing for pregnant women at risk of gestational diabetes. 

Poland is slowly expanding beyond its position as a central European generics hub. More established companies are adding innovative medicine pipelines and a small number of biotechs are making international deals.  

The UK’s national rollout of hybrid closed loop (HCL) technologies marks NHS England as the global leader in providing equitable and fair access to next-generation diabetes management, Partha Kar, type 1 diabetes and technology lead, told Medtech Insight. Market leader Medtronic offers perspective.

This week, AdvaMed and MITA win appeal to prevent repair companies from hacking medical devices, the FDA cleared Abbott’s Libre Rio CGM for OTC sales, J&J MedTech wins expanded clearance for Velys knee medical robot, the FDA updates its AI program, Canary Speech secures $13m in series A funding and Xeltis won FDA approval for an IDE submission to begin enrolling patients for a pivotal study for aXess.  

The FDA has given the green light to over-the-counter sales of Abbott’s Lingo blood glucose monitoring device, which is intended for use by healthy people who want to track the crucial biomarker.

In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb highlights key interviews with Philips’ CEO Roy Jakobs on NAM’s framework on AI, BD’s CTO Beth McCombs R&D initiatives and HSS spine co-chair Sheeraz Qureshi on his vision for integrating AI tech. Hannah Daniel discusses the FDA’s new initiative to create an idea lab for medical device use at home and a new feature on the Apple Watch to help people with Parkinson's disease overcome freezing gait.   

Eledon Pharmaceuticals’ CD40 Ligand blocker has yielded impressive results for post-transplant immunosuppression and cutting-edge transplant doctors have also used it for pig-to-human kidney and heart transplants, opening up the field of xenotransplantation.   

In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb highlights interviews with Abbott’s head of Lingo Biowearables and top executives at Twin Health. Reed Miller provides an update on J&J MedTech’s launch of the Ottava soft-tissue robotic surgery system and Barnaby Pickering talks about his recent interview with Leo Grady, former CEO of Paige AI, to talk about his new start-up Jona.

In 2024, Visana Health will leverage $10.1m in seed funding to expand its holistic, value-based virtual clinic to add conditions that differently or disproportionally affect women and provide at-home testing. Health plans and employers are taking notice, and Visana’s CEO expects further investment to follow.

Women’s health start-ups focusing on areas of high unmet need such as menopause, infertility, preventive care and post-partum care will continue to attract investors, experts say. Meanwhile, machine learning and AI, as well as next gen-treatments such as psychedelic therapy, stand to drive advancements in the space.

This week, FDA announced plans for cybersecurity and meetings to discuss orthopedic device safety and radiological devices. ProPublica and the Pittsburgh Post-Gazette insist that the FDA to divulge more information about the ongoing Philips recalls. SetPoint is trying to treat Crohn's disease with its vagus nerve stimulator. ITC delayed the Apple Watch patent case again.

A small scale study has indicated that GLP-1 agonists could restore normal HbA1c levels in type I diabetics. This therapy could be a huge step forward for the treatment of this chronic disease if this benefit is shown in larger studies.  

Lifespin is working on tools to characterize a patient’s metabolism and provide more detailed information about a disease.

Abbott launched its first biowearable for consumers in the UK with plans to expand in Europe and the US. Analysts are optimistic about continued growth of Libre FreeStyle amid drivers such as CGM adoption by non-insulin users, expected 15-day sensor, streaming capability and integration with Tandem insulin pump.

OrganOx will use the new money to scale up their commercial presence and further validate the efficacy of their Metra system.

In this second of a series of Exec Chats with leaders at major diabetes companies presenting at ADA’s Scientific Sessions 2023, CEO John Sheridan provides a tour of Tandem’s next-gen innovations and the competitive landscape.