ivWatch said today that it won CE Mark clearance for its intravenous infiltration/extravasation monitoring device. The company’s ivWatch Model 400, which has FDA clearance, is sold in the U.S. through group purchasing contracts with Premier and Vizient. ivWatch also touted that it obtained ISO 13485:2016 certification through the Medical Device Single Audit Program. “Peripheral IV […]
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. […]
ivWatch wins medical device license in Canada
ivWatch said today that it landed a medical device license from Health Canada permitting the sale of its intravenous infiltration/extravasation monitoring device. The company’s FDA-approved sensor, which is roughly the size of a pencil eraser, uses light to measure the optical density of the tissue surrounding an IV insertion site, monitoring the flow of fluid […]
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 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 […]
Siemens Healthineers and Hill-Rom team up to provide diabetes tools to primary care providers
Siemens Healthineers (NYSE:SI) and Hill-Rom (NYSE:HRC) inked a co-marketing agreement to provide an array of point-of-care diagnostic instruments for diabetes to primary healthcare providers in the U.S. The offering is slated to include Siemens’ DCA Vantage Analyzer for HbA1c testing, the Clinitek Status+ Urine Chemistry Analyzer for kidney testing and Hill-Rom’s Welch Allyn RetinaVue Network and imaging tech […]
Medtech stories we missed this week: April 27, 2018
From DuPuy Synthes’s spinal implant launch to Lumendi’s FDA clearance, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. DePuy Synthes launches spinal implants DePuy Synthes announced in an April 26 press release that it has launched its Proti 360º integrated titanium family of interbody devices that are designed to […]
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