First, the good news about pandemics – and in 2024, there was big “good news.” Science Magazine named lenacapavir (Gilead Sciences Inc.) as the Breakthrough of the Year. In two separate trials, lenacapavir prevented HIV transmission with 100% efficacy in cisgender African women and 99.9% efficacy in men and gender-diverse persons when administered twice a year.
A spate of year-end collaborations highlights growing enthusiasm for expanding use of automated insulin delivery devices or pumps in management of type 1 diabetes only to include many patients with type 2 diabetes. Beneficiaries include pump makers Tandem Diabetes Care Inc., Insulet Corp. and Medtronic plc as well as the leaders in the continuous glucose monitoring market, Abbott Laboratories and Dexcom Inc.
Dexcom Inc. put real money behind expanding its integration efforts, with a $75 million investment in the $200 million series D for Ōura Health Oy, the maker of the Ōura smart ring. Ōura and Dexcom also provided details on a strategic partnership that integrates data from Dexcom’s continuous glucose monitors with vital sign, sleep, stress, heart health and activity data from the Ōura ring.
Electrocore Inc. Quell(ed) any concerns about its commitment to the bioelectronic health segment with an agreement to acquire Neurometrix Inc., maker of the Quell, a wearable device and cloud-enabled neuromodulation platform to treat fibromyalgia and lower extremity chronic pain. Neurometrix is expected to divest its other primary product, Dpncheck, a point-of-care screening test for diabetic peripheral neuropathy, prior to the acquisition.
Becton, Dickinson and Co. reached an agreement with the U.S. Securities and Exchange Commission (SEC) to resolve an investigation related to allegations that the company misled investors regarding the Alaris infusion system, which BD added to its portfolio with the $12.2 billion acquisition of Carefusion in 2015. BD will pay a $175 million civil penalty and agreed to a cease and desist order for the device.
Labcorp Holdings Inc. launched its new H5N1 bird flu molecular test for humans in the U.S. as an international outbreak of the disease continues to spread in cows and poultry – and people. As BioWorld reported recently, just one mutation would make the flu variant highly transmissible in humans.
Heartbeam Inc. received U.S. FDA 510(K) clearance for its portable, non-invasive electrocardiogram system that enables on-the-go recording of heart signals. The cable-free, credit card-sized device uses five electrodes to capture signals from three directions and can be used whenever a patient feels symptoms, overcoming the challenge of identifying intermittent arrhythmias, which are often not experienced during scheduled appointments, without requiring patients to wear a device continuously.
Capstan Medical Inc. closed an oversubscribed series C fundraising round that brought in $110 million for the structural heart-focused company. Capstan aims to combine valve implants, advanced catheter technology and a robotic platform to facilitate expanded minimally invasive treatment options for patients with heart valve disease.
Bring your dog to work day looks a little different at Spotitearly. The Tel Aviv-based company asks its canine workers to bring their whole selves to the job – particularly their finely trained noses – to help suss out cancer in breath samples. The dogs’ unique capabilities are interpreted by AI to capture canine indicators humans might miss and the combo has remarkably high accuracy, 93% or better in three of the four common cancers tested.
The force is with Field Medical Inc. as it celebrates the U.S. FDA’s decisions to grant breakthrough device designation (BDD) to its Fieldforce ablation system and to accept it into the agency’s Total Product Life Cycle Advisory Program pilot. Field Medical designed the Fieldforce pulsed field ablation catheter specifically to treat ventricular tachycardia. The BDD applies to its use in monomorphic scar-related VT.
