Roche announced today that it launched its Cobas Pulse system in select countries accepting CE mark approval in Europe. Basel, Switzerland–based Roche designed its Cobas Pulse system to combine the form factor of a high-performance blood glucose meter with simple usability and expanded digital capabilities comparable to that of a smartphone. The platform joins Roche’s […]
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 […]
Glytec partners with Roche to enhance insulin dosing decision support software
Glytec announced today that it entered into a strategic partnership with Roche Diagnostics USA for a digital health collaboration. Waltham, Massachusetts-based Glytec’s partnership combines its FDA-cleared Glucommander insulin dosing decision support software with Roche’s expertise in medical devices and IT solutions in an effort to address the challenges associated with inpatient blood sugar management at […]
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. […]
Abbott CEO touts future of biowearables in first-ever healthcare company keynote at CES
Abbott (NYSE:ABT) Chairman & CEO Robert B. Ford highlighted what the future holds as he presented the first healthcare keynote ever at CES. Abbott Park, Illinois-based Abbott is designing biowearables based on its Freestyle Libre platform, with sensor technology designed to track key signals in the body like glucose, ketones and lactate, and could even one […]
Laborie acquires exclusive license for drug-coated baloon treatment for urethral strictures
Laborie Medical Technologies announced today that it acquired an exclusive license to the Optilume urethral drug-coated balloon (DCB). Portsmouth, New Hampshire-based Laborie purchased a perpetual, exclusive license to Optilume — developed by Urotronic — following FDA approval in December 2021. The DCB platform received CE mark approval for use in male anterior urethral strictures in […]
Senseonics expects FDA approval for next-gen 180-day CGM in ‘coming weeks’
Senseonics (NYSE:SENS) announced that it anticipates the FDA to decide within weeks on approval of its new CGM system. The company seeks a premarket approval supplement for the next-generation Eversense 180-day implantable continuous glucose monitoring (CGM) system. Data presented earlier this year demonstrated strong accuracy. The next-generation Eversense matched performance levels compared to the current […]
