Medtronic (NYSE:MDT) said today that it won CE Mark approval in the European Union for its MiniMed 670G hybrid closed-loop insulin management system for Type I diabetes patients age 7 and older. Fridley, Minn.-based Medtronic said it has clinical programs under way to back expanded indications for the device, which is designed to continuously monitor regulate […]
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Medtech stories we missed this week: June 22, 2018
From Accuray’s India approval to Masimo and PositiveID launching a Bluetooth-enabled thermometer, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. India approves Accuray’s Radixact X9 radiation therapy device Accuray announced in a June 21 press release that it has received an Atomic Energy Regulatory Board Type Approval in […]
Impel NeuroPharma readies trial for intranasal drug-device migraine treatment
Impel NeuroPharma said today that the FDA gave it the green light to proceed with its Phase III clinical trial of INP104 – a drug delivered by Impel’s intranasal delivery device for the treatment of acute migraine. The company expects to start enrolling patients in the pivotal trial in the second half of this year. […]
Tandem wins FDA nod for insulin pump with predictive low glucose suspend feature
The FDA this week approved Tandem Diabetes Care‘s (NSDQ:TNDM) t:slim X2 insulin pump with a predictive low glucose suspend feature designed to cut the frequency and duration of hypoglycemia. The San Diego, Calif.-based company said that upon launch, its new product will also feature Dexcom‘s (NSDQ:DXCM) G6 continuous glucose monitoring system. Tandem expects that the […]
FDA approves Senseonics’ implantable continuous glucose monitor
The FDA this week approved Senseonics‘ (NYSE:SENS) Eversense continuous glucose monitor for use in people ages 18 and older with diabetes. The device is the first CGM system to feature an implantable sensor that can be worn for up to 90 days. Senseonics’ Eversense device includes a small sensor that is implanted just below the […]
Mercator MedSystems raises $11m in Series D for micro-infusion catheter system
Mercator MedSystems said this week that it raised $11 million in a Series D equity round led by Shenzhen Salubris Pharmaceuticals, with participation from current Mercator investors and other unnamed new investors. The Emeryville, Calif.-based company plans to use its newly-acquired funds to support the clinical development of its micro-infusion catheter system, the Bullfrog device. […]
Medtronic’s MiniMed system wins FDA nod for pediatric indication
The FDA this week expanded its approval for Medtronic‘s (NYSE:MDT) MiniMed 670G hybrid closed-loop diabetes management device to include people ages 7 to 13 with Type I diabetes. The system, which automatically monitors blood sugar levels and doses basal insulin accordingly, was initially approved in the U.S. for people ages 14 and older. Medtronic’s MiniMed […]
Lubrizol LifeSciences & Particle Sciences to host micro- & nano-particulate drug product development seminar
[PRESS RELEASE] – The Lubrizol Corporation announces its LifeSciences Pharmaceutical business will organize the first annual “Complex Drug Delivery Seminar: Micro- and Nano- Particulate Drug Product Development and Manufacturing” in Amsterdam on Thursday, September 27, 2018. Lubrizol LifeSciences through its pharmaceutical CDMO, Particle Sciences, and Co-Sponsor, Corbion, a world leader in bioresorbable polymers, would like to invite […]
Cerebral Therapeutics raises $3m for epilepsy drug-device therapy
Cerebral Therapeutics closed a $3 million Series A financing round this week to support the development of its drug-device therapy designed for patients with refractory epilepsy. The Aurora, Co.-based company’s product uses an implanted, refillable catheter system to deliver a continuous, intracerebroventricular dose of an anti-epileptic drug – valproic acid. Investors that contributed to Cerebral […]
Companion Medical launches data management system for smart insulin pen
Companion Medical launched today Insights by InPen, a diabetes management system that aggregates and analyzes data from Companion’s connected insulin injection pen. The company’s Insights by InPen system provides users with their average glucose, average total daily insulin dose, dose calculator usage, missed doses and more, according to Companion Medical. The system is available in […]