Medtronic Wins Japanese Approval of Transcatheter Pacing System
Medtronic has received regulatory approval in Japan for its tiny pacemaker, the Micra transcatheter pacing system (TPS).
The Micra TPS is less than one-tenth the size of traditional pacemakers. The device received FDA approval in April 2016.
Philips Gains FDA Marketing Clearance for Intellivue Guardian Solution
Netherlands–based Royal Philips has received FDA marketing clearance for the Philips Wearable Biosensor.
The device is designed to aid clinicians in the early detection of subtle signs of patient deterioration, by measuring heart rate, respiratory rate, posture and detecting falls.
The data is then transmitted to the device, which analyzes the measurements over time and notifies the clinician when preset limits are exceeded.
The device received a CE mark in 2016.
FDA Awards Voxello Marketing Clearance for Speech Generation Device
Coralville, Iowa–based Voxello has won FDA marketing clearance for the Noddle speech generation device, used to detect voluntary gestures in hospitalized patients.
The device enables patients to control up to three different devices with a single touch.
DiaCarta Nabs CE-IVD for its Non-Invasive Colorectal Cancer Test
California–based DiaCarta has achieved CE-IVD approval for ColoScapeTM, a colorectal cancer mutation detection kit.
The device is designed to detect mutations in DNA extracted from solid tumor, plasma or stool samples. The device can complete an assay in less than 2.5 hours.
Zimmer Biomet Recalls Comprehensive Reverse Shoulder
Zimmer Biomet has issued a recall for its comprehensive reverse shoulder because the shoulder replacement devices have been fracturing at a higher rate than expected.
The manufacturing dates of the recalled device are between Aug. 25, 2008 and Sept. 27, 2011.
Illumina Receives CE Mark for VeriSeq Analysis Software
San Diego–based, Illumina has qualified for the CE mark for an expanded VeriSeq NIPT analysis software for clinical laboratories in the European Union.
The software is designed for larger batches of 48 samples versus the current 16 samples. It generates quantitative scores to aid in the detection and differentiation of fetal aneuploidy status for chromosomes 21, 18, 13, X and Y by analyzing data generated from cell-free DNA fragments isolated from blood specimens in pregnant women of at least 10 weeks gestation.