San Diego-based Tandem Diabetes Care Inc. reported financial results for the third quarter of 2019, with worldwide pump shipments soaring 112% to 17,839 pumps from 8,434 pumps in the same period a year ago. Revenue rose 105% to $94.7 million, up from $46.3 million in the third quarter of 2018.
Tech giant Google LLC is taking aim at the Apple Watch with its plan to acquire wearables pioneer Fitbit Inc., of San Francisco, for $2.1 billion, or $7.35 per share, in an all-cash transaction expected to close sometime next year.
The U.S. FDA's breakthrough devices program continues to rack up new designations, this latest one for Shréis Scalene Sciences LLC's Cytotron device. The noninvasive whole-body system, which is intended to break down or interrupt the growth of malignant tumors, is already CE marked and available in the European Union.
Los Altos, Calif.-based Heartvista Inc. has received the U.S. FDA's nod for its One Click autonomous MRI acquisition software for cardiac exams. The company said that One Click is the first artificial intelligence (AI)-assisted solution designed specifically with the goal of enhancing the performance and results of cardiac MRI scans.
Genomic testing firm Veracyte Inc. is eyeing 2021 for the launch of its noninvasive nasal swab classifier for early lung cancer detection and diagnosis, following preliminary clinical data demonstrating high sensitivity in low-risk patients and high specificity in high-risk patients with known lung nodules. The South San Francisco-based company is developing the nasal swab test in collaboration with Johnson & Johnson Inc.'s Lung Cancer Initiative, part of a long-term strategic collaboration that also aims to speed commercialization of Veracyte's Percepta genomic sequencing classifier.
Spinal cord stimulation company Gtx Medical BV, of Eindhoven, Netherlands, is merging with San Juan Capistrano, Calif.-based Neurorecovery Technologies Inc. in a move aimed at accelerating access to new therapies for spinal cord injury on both sides of the Atlantic. The combined company, which will be known as Gtx Medical BV, is developing both implantable and transcutaneous technologies for people living with paralysis. Financial terms of the deal were not disclosed.
Diagnosis and treatment of infections typically occurs after people exhibit obvious signs of illness, such as fever or a cough. By then, they may already have exposed others and are well on the way to developing more serious symptoms themselves. In the military, such delays can hamper medical countermeasures to contain potential outbreaks and reduce downtime among active duty personnel. Now, Amsterdam-based Royal Philips NV and the U.S. Department of Defense's Defense Threat Reduction Agency and Defense Innovations Unit have built an early warning algorithm – using artificial intelligence – to detect infection before a person shows any signs or symptoms of infection.
The U.S. FDA has given 510(k) clearance to the Advanced Intelligent Clear-IQ Engine (AiCE) for Canon Medical Systems USA Inc.'s Aquilion Precision CT scanner. The regulatory green light brings artificial intelligence (AI)-based image reconstruction capabilities to the world's first ultra-high resolution CT imaging system.
Sky Medical Technology Ltd. has cinched FDA clearance for a third indication for its geko device, a noninvasive, battery-powered wearable technology designed to increase blood flow in the deep veins of the lower legs. The Daresbury, U.K.-based company already had the agency's blessing for geko's use immediately after surgery to stimulate the calf muscles to prevent venous thromboembolism (VTE) and preoperative reduction of edema. Now the FDA has granted geko 510(k) clearance for stimulation of calf muscles to curb venous thrombosis in nonsurgical patients at risk of VTE.
