Welldoc announced today that it will offer its BlueStar digital health solution with Dexcom’s G6 CGM system as a single platform. Columbia, Md.-based Welldoc’s FDA-cleared BlueStar system offers guidance to individuals through the self-management of diabetes, while Dexcom’s G6 continuous glucose monitoring (CGM) system measures glucose levels just beneath the skin’s surface and wirelessly transmits data every five […]
Patient Monitoring
Glytec launches new insulin management system
Glytec announced today that it introduced the latest version of its eGlycemic Management System (eGMS) for managing insulin. Waltham, Mass.-based Glytec’s eGMS is centered around the FDA-cleared Glucommander algorithm, which leverages real-time and historical data to recommend insulin dosing by learning each patient’s insulin sensitivity and anticipating future needs, leading to a personalized treatment regime […]
Insulet touts results from Omnipod 5 study, expects launch this year
Insulet (NSDQ:PODD) touted positive results from the first pivotal trial for its Omnipod 5 automated insulin delivery system. Omnipod 5 is the world’s first tubeless, wearable system designed to continuously adapt insulin delivery based on glucose levels and trends, according to a news release. Acton, Mass.–based Insulet said the device, which has FDA breakthrough device […]
FDA sets patient-generated health data meeting
The FDA today announced a virtual public meeting to discuss patient-generated health data (PGHD) and its potential impact across the healthcare ecosystem. Health and treatment history, biometric data, symptoms, and lifestyle habits can all be categorized as PGHD. Sources of PGHD, data quality measures, interoperability and potential impacts of the data in regulatory and healthcare […]
Bigfoot Biomedical raises $57M to support its diabetes management tech
Bigfoot Biomedical announced today that it secured $57 million in financing as it works toward commercializing its diabetes management program. Madryn Asset Management provided the financing for Bigfoot, which is developing the Bigfoot Unity diabetes management program designed to simplify and connect aspects of insulin management to enable personalized, proactive and remote patient care, according to […]
Baxter wins FDA clearance for AK 98 hemodialysis machine
Baxter (NYSE:BAX) announced today that it recieved FDA clearance for its next-generation artificial kidney 98 (AK 98) dialysis machine. Deerfield, Ill.-based Baxter’s AK 98 machine is designed as a portable and easy-to-use system to administer hemodialysis (HD) treatments. It offers encrypted, two-way connectivity to enable the system to pull prescriptions directly from the electronic medical record […]
Qardio lands 510(k) for ambulatory ECG device
Qardio this week announced that it received FDA 510(k) clearance for its QardioCore ambulatory ECG device. QardioCore is an extension of Qardio’s remote patient monitoring platform for primary care and hypertension monitoring to acute care and cardiology. The device requires no special skin preparation, gels, adhesives or patches. It can be easily self-fit, removed and […]
10 Minnesota medtech startups you need to know
Medical device startups can use all the help they can get, including from government-sponsored investment funds. In Minnesota, one of the nation’s top three medtech hubs, the state Department of Employment and Economic Development (DEED) has distributed $1.6 million per year since 2019 in innovation grants to tech startups — many of them in the […]
Senseonics sinks on mixed bag Q4, massive bottom-line slide
Senseonics (NYSE:SENS) shares took a hit today on fourth-quarter losses that missed the consensus earnings forecast. SENS shares were hit hard at market close yesterday after financial results were released, dipping -15.7% to $2.69 per share. In pre-market trading this morning, they are down -7.8% at $2.48 per share. The Germantown, Md.-based implantable continuous glucose monitor […]
Capsule lands Frost & Sullivan award for remote ventilator monitor
Frost & Sullivan today announced that it awarded Capsule with a 2021 New Product Innovation Award. Capsule received the award for its Ventilated Patient Surveillance workstation that helps frontline healthcare providers identify patients in respiratory distress. It extends the reach of intensive care unit staff over the full range of critical care patients. The workstation […]
Forest Devices touts study of stroke detection tech
Forest Devices this week touted study results for its AlphaStroke technology for identifying patients with large vessel occlusive (LVO) strokes. Pittsburgh-based Forest Devices, one of MassDevice’s 2020 medical device startups you need to know, designed the AlphaStroke platform to detect stroke and LVO, offering first responders the ability to use the system to triage patients […]
