MIT researchers are touting a platform aimed at helping patients maintain healthy glucose levels by streamlining the diabetes management process. The MIT researchers say it’s hard for people with diabetes to maintain a treatment regimen. Typically at every meal, they need to estimate carbohydrate content, draw blood to measure blood glucose levels, and calculate the […]
Drug-Device Combinations
FDA grants IDE approval for Capillary Biomedical’s 7-day-wear infusion set
Capillary Biomedical announced today that it received FDA investigational device exemption (IDE) for its SteadiFlow infusion technology. Irvine, California-based Capillary Biomedical designed its new SteadiFlow seven-day-wear infusion set technology to significantly extend patient wear time to a week and maintain insulin stability. The SteadiSet infusion set, powered by the SteadiFlow technology platform, features an integrated […]
Ahead of G7 launch, Dexcom CEO plans for ‘more activity than we’ve ever seen’ in 2022
With a major product approval and launch in its sights, Dexcom prepares for a big year in 2022. Across 2021, Dexcom (NSDQ:DXCM) took several steps forward. The company touted its next-generation G7 continuous glucose monitor (CGM) and announced a significant regulatory nod and partnership for real-time application programming interfaces (APIs), to list a couple. As […]
FDA grants new drug approval to Glenmark’s rhinitis-treating nasal spray
Glenmark Pharmaceuticals announced today that it received FDA approval for a new drug application (NDA) for Ryaltrais. Ryaltris, a fixed-dosed, prescription drug product nasal spray treats symptoms of seasonal allergic rhinitis in adults and pediatric patients over 12 years of age in the U.S. Glenmark’s fully owned subsidiary, Glenmark Specialty S.A. (Switzerland), received the NDA […]
Fort HealthCare, Ivenix partner on infusion safety effort with smart pump
Ivenix announced today that it successfully implemented its smart infusion pump at the Fort HealthCare hospital in Wisconsin. Boston-based Ivenix designed its Ivenix Infusion System, a combination of a large-volume infusion pump and infusion management software, to offer unique capabilities within the infusion therapy market, with pumps deployed at Fort HealthCare set to connect with […]
Dali Medical Devices completes first implementation of SAN-Light passive safety needle
Dali Medical Devices announced today that it completed the first commercial implementation of the SAN-Light passive safety needle. Tel Aviv, Israel-based Dali designed the SAN-Light single-use, sterile, hypodermic safety needle for compatibility with any Luer-lock syringe for subcutaneous or intramuscular drug administration. SAN-Light makes up part of Dali’s SAN (safe auto needle) family of safety […]
Dexcom CEO touts unprecedented performance of G7 in clinical trial, awaits FDA decision
Exciting new data for the next-generation Dexcom (NSDQ:DXCM) G7 continuous glucose monitor (CGM) surprised even the company’s leadership. Dexcom Chair, President & CEO Kevin Sayer, presenting clinical study results for the G7 at the 40th Annual J.P. Morgan Healthcare Conference, has previously lauded the expected impact of the wearable glucose monitor, and the new data […]
Medtronic CEO confirms FDA warning could affect approval timing for next-gen diabetes tech
An FDA warning over Medtronic’s (NYSE:MDT) diabetes business introduces uncertainty into new approvals, the company’s CEO said. Last month, Medtronic received an FDA warning letter highlighting inadequacies in specific medical device quality system requirements at its diabetes business’ Northridge, California, facility. Today at the 40th Annual J.P. Morgan Healthcare Conference, CEO Geoff Martha said there […]
Hugo, renal denervation and diabetes businesses to drive growth despite setbacks, Medtronic CEO says
Although three major pipelines at Medtronic (NYSE:MDT) have hit recent speed bumps, CEO Geoff Martha reiterated his belief that they will be major growth factors. In October, the medtech giant announced that the clinical study of its Symplicity Spyral renal denervation (RDN) system for hypertension would continue into next year after lacking the positive results needed to end enrollment […]
FDA clears Glaukos’ iPrime
Glaukos (NYSE:GKOS) announced that it received FDA 510(k) clearance for its iPrime viscodelivery system. San Clemente, California-based Glaukos designed the iPrime viscodelivery system as a sterile, single-use, minimally invasive device for delivering viscoelastic fluid during ophthalmic surgery. Glaukos develops medical devices and pharmaceuticals centered around novel therapies for treating glaucoma, corneal disorders and retinal diseases. […]
