One company has developed a promising device and care model to reduce the exacerbations of chronic obstructive pulmonary disease (COPD) that often send patients to the hospital and contribute to accelerated disease progression. Patients who used a wearable remote cardiorespiratory monitoring device developed by Spire Inc. experienced a 64% decrease in cardiopulmonary-specific admissions in a study published in the International Journal of COPD.
The U.S. FDA reported that Baxter International Inc. issued an Urgent Medical Device Correction for its Life2000 ventilation systems in response to reports of potential patient oxygen desaturation events when connected to a third-party oxygen concentrator.
A new blood test developed by Durin Technologies Inc. and Rowan-Virtua School of Osteopathic Medicine detected the presence of Alzheimer’s disease pathology in nearly all asymptomatic patients who went on to developed cognitive impairment or dementia, a study in the Journal of Alzheimer’s Disease found. The test uses eight autoantibody biomarkers to identify patients with the disease at pre-symptomatic, prodromal and mild-moderate stages of disease.
From Carl Icahn’s point of view, Illumina Inc.’s desired reintegration of its former spinoff is more a poisoned chalice than a holy Grail. In his opening salvo to a proxy fight, Icahn published an open letter March 13 to other Illumina shareholders referencing the “extreme displeasure” of investors with Illumina’s “reckless” determination to acquire Grail Inc., despite European regulators’ strong opposition to the deal.
Abbott Laboratories received U.S. FDA clearance for the Freestyle Libre 2 and Freestyle Libre 3 continuous glucose monitoring (CGM) sensors for integration with automated insulin delivery (AID) systems. AID systems automatically adjust and administer insulin via a pump based on blood glucose levels determined by the sensors. Abbott said it was partnering with multiple AID manufacturers in the U.S. and Europe.
Three months earlier than anticipated, CMS published its final local coverage determination (LCD) for continuous glucose monitors and included more people with diabetes than expected. The new policy expands coverage from individuals with type 1 diabetes or type 2 diabetes using multiple daily injections of insulin to anyone treated with insulin, essentially doubling the market for manufacturers of continuous glucose monitors (CGMs).
Boomerang Medical Inc. knocked out its first target with a U.S. FDA breakthrough device designation for its bioelectronic device for treatment of inflammatory bowel disease (IBD). The technology stimulates the parasympathetic nervous system to reduce inflammation for individuals with both types of IBD, Crohn’s disease and ulcerative colitis.
Theranica Bio-Electronics Ltd. broadened its U.S. FDA clearances for the Nerivio prescription wearable to include migraine prevention in individuals with or without aura. The remote electrical neuromodulation (REN) device offers an alternative to the significant population of migraine patients who do not respond to or cannot tolerate prescription drugs that treat the condition.
Current Surgical Inc. secured $3.2 million in a seed funding round to support development of its surgical needle platform to precisely destroy unresectable tumors. True Ventures led the round with participation from 1517 Fund and Scifounders.
While still pending clearance in the U.S., Medtronic plc’s Minimed 780G advanced hybrid closed loop (AHCL) system continues to post strong results in clinical trials. Results of two studies presented at the 2023 Advanced Technologies & Treatments for Diabetes Conference in Berlin on Feb. 27 demonstrated that patients with type 1 diabetes (T1D) who used the device for one year maintained a 26.7% increase in time in range for adults and a 14% increase in time in range for children aged 7 to 17 compared to their baseline using multiple daily injections with a continuous glucose monitor (CGM).
