Opticyte announced today that its Cell O2 patient monitor received breakthrough device designation from the FDA. Seattle-based Opticyte designed Cell O2 to use noninvasive optical spectroscopy technology. It measures and detects systemic low oxygen levels inside cells. This provides continuous monitoring of cellular oxygen levels during hospitalization. The startup said in a news release it […]
Patient Monitoring
Dexcom appoints former J&J exec as CCO, sets 2023 guidance
Dexcom (Nasdaq:DXCM) announced today that it appointed Teri Lawver to its newly created role of chief commercial officer (CCO). Lawver’s position oversees the global commercial organization at the continuous glucose monitoring (CGM) technology developer. She holds responsibility for global sales, marketing and customer experience. Before joining San Diego-based Dexcom, Lawver spent two decades in a […]
Know Labs wins new glucose monitoring patent
Know Labs (NYSE:KNW) announced today that it received a new patent equating its diagnostic technology to the current glucose monitoring standard. Seattle-based Know Labs develops the Bio-RFID technology. It uses spectroscopy to direct electromagnetic energy through a substance or material to capture a unique molecular signature. It integrate into wearable, mobile or bench-top form factors. […]
Study backs use of Masimo hemoglobin monitoring during cesarean delivery
Masimo (Nasdaq:MASI) today announced positive data from a study of its hemoglobin monitoring for patients undergoing cesarean section. The study observed patients undergoing elective cesarean section (CS) with antepartum hemorrhage. Researchers used noninvasive, continuous hemoglobin monitoring with Masimo SpHb. The study demonstrated significant positive correlations between SpHb and invasive hemoglobin (Hb) values. “In patients undergoing […]
HeartBeam expects FDA to approve AIMI system for acute care settings in 2023
In a letter to shareholders, HeartBeam (Nasdaq:BEAT) founder and CEO Branislav Vajdic laid out potential regulatory timelines for 2023. Calling 2022 “a transformative year,” Vajdic updated the expectations for HeartBeam’s AIMIGo and AIMI systems. The company designed AIMIGo as a credit card-sized, 12-lead 3D vector electrocardiogram (ECG) device. It developed AIMI for acute care settings. […]
The 10 biggest diabetes tech stories from 2022
2022 represented a landmark year for next-generation diabetes tech. Here are the biggest stories from the past year. Some companies picked up major regulatory nods. Others experienced major regulatory setbacks. Partnerships were formed and ended, while mergers and acquisitions came and went. There were many stories to choose from in the world of diabetes tech, […]
ITC rules in favor of AliveCor in patent spat with Apple
AliveCor announced today that the International Trade Commission (ITC) ruled that the Apple Watch infringed its patented technology. Along with the final determination, the ITC issued a limited exclusion disorder (LEO) and a cease and desist order. It set a bond in the amount of $2 per unit of infringing Apple Watches imported or sold […]
BioTelemetry, CardioNet to pay nearly $45M to resolve False Claims Act violation allegations
BioTelemetry and its CardioNet subsidiary agreed to pay $44.875 million to resolve False Claims Act violation allegations. Both companies now belong to Philips after it acquired BioTelemetry for $2.8 billion last year. The U.S. Department of Justice alleged that the companies knowingly submitted false claims surrounding heart monitoring tests. DOJ claims the companies submitted claims […]
FDA clearance for Dexcom G7 marks a ‘huge leap’ forward, COO Jake Leach says
After plenty of anticipation — and a bit of waiting — the next-generation Dexcom G7 continuous glucose monitor is finally here. In mid-2021, Dexcom (Nasdaq:DXCM) CEO Kevin Sayer told Drug Delivery Business News that its next-generation CGM would be “wonderful.” At the time, he said enthusiasm over the Dexcom G7 sat at an all-time high. About […]
Abbott FreeStyle Libre 3 links with automated insulin delivery system for use in Europe
Abbott (NYSE:ABT) today announced compatibility between its FreeStyle Libre 3 sensor and the mylife Loop from Ypsomed and CamDiab. Combined, the technologies create a smart, automated process for insulin delivery based on real-time glucose data. The companies launched their automated insulin delivery (AID) system in Germany. They intend to offer it in additional European countries […]
Amalgam Rx, Novo Nordisk expand partnership on connected insulin delivery devices
Amalgam Rx announced today that it expanded its global agreement with Novo Nordisk over the commercialization of Dose Check. Wilmington, Delaware-based Amalgam Rx develops the Dose Check digital insulin initiation and titration app. It designed the app to help people with type 2 diabetes using basal insulin. The two companies partnered to incorporate and integrate […]