GE HealthCare today announced an agreement with Ulrich Medical to offer a GE HealthCare branded contrast media injector in the U.S. The CT motion multi-dose syringeless injector delivers iodinated contrast media for computed tomography (CT) imaging procedures. It helps to reduce procedure setup time and increase patient throughput by eliminating time-consuming preparation steps. Additionally, it […]
Imaging
Iradimed withdraws 510(k) application for MR-compatible IV pump
Iradimed (Nasadq:IRMD) announced that it voluntarily withdrew an FDA 510(k) application for its new model MR IV pump. Winter Springs, Florida-based Iradimed said it learned that the FDA likely wouldn’t have time to finish clearance activities for the pending submission. Upon learning this, the company decided to voluntarily withdraw its application on Oct. 5. The […]
FDA approves Guerbet’s Optiray imaging bulk package
Guerbet (EPA:GBT), which specializes in medical imaging including contrast agents, has received FDA approval for its Optiray imaging bulk package, which can be used to fill sterile disposable syringes for use with CT imaging. The imaging bulk package is intended to reduce the number of single-dose vials when used with a power injector and contrast […]
Medtech stories we missed this week: August 3, 2018
From Esaote launching its new ultrasound device to Nipro’s Infraredx launching in Japan, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Esaote launches new ultrasound devices Esaote announced in an Aug. 2 press release that it has launched its new MyLab X7, MyLab X6 and MyLab X5 ultrasound systems. […]
Medtech stories we missed this week: July 27, 2018
From the FDA clearing LifeSignal’s wireless ECG to Zavation receiving FDA clearance for its expandable corpectomy cage, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. FDA clears LifeSignal’s wireless ECG LifeSignals announced in a July 26 press releasethat it has received FDA clearance for its wireless LP1100 Life Signal […]
Medtech stories we missed this week: July 13, 2018
From Angiodroid receiving CE Mark approval to Masimo launching its vital signs app, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Angiodroid wins CE Mark for Angiopulse IABP Angiodroid announced in a July 11 press releasethat it has received CE Mark approval for its AngioPulse intra-aortic balloon pump […]
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 […]
Medtech stories we missed this week: June 8, 2018
From Royal Philips receiving FDA clearance to NeuroPace launching its epilepsy treatment device, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. FDA clears Philips’s Ingenia Elition 3.0T MR scanner Royal Philips announced in a June 5 press releasethat it has received FDA 510(k) clearance for its Ingenia Elition […]
Medtech stories we missed this week: May 25, 2018
From Mauna Kea receiving FDA clearance to Medacta getting clearance for its pedicle screw placement guide, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Mauna Kea wins FDA nod for neurosurgery indication Mauna Kea announced in a May 24 press release that it has received FDA 510(k) clearance […]
Medtech stories we missed this week: May 11, 2018
From ReShape submitting an approval application to Health Canada to Conavi receiving FDA clearance, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. ReShape submits for Health Canada approval of ReShape balloon ReShape announced in a May 10 press release that it has submitted an application to the Medical Devices Bureau of […]
