FDA Clears First Neonatal MRI Device
The FDA cleared Aspect Imaging’s Embrace Neonatal MRI System as the first MRI device specifically for neonatal brain and head imaging in neonatal intensive care units.
The system includes a temperature-controlled incubator that minimizes movement of the baby. The device can be used on neonates with a head circumference up to 38 centimeters and weight between 1 and 4.5 kilograms.
The unit does not require a safety zone or a radiofrequency shielded room. It is fully enclosed, so medical device implants in close proximity to the system are not required to be “MR Conditional” or “MR Safe.”
Royal Philips’ Psoriasis Treatment Device Cleared
Royal Philips received 510(k) clearance from the FDA for its BlueControl light therapy device for treating milk psoriasis.
A Class II, home-use prescription product, the wearable device obtained CE Mark approval in 2015 and has been rolled out in select European countries, including the U.K. and Germany.
The company hopes to launch the device in the U.S. market in early 2018, in collaboration with dermatologists and patient support groups.
FDA Clears Saebo’s Virtual Reality Rehab System
Medical virtual reality device manufacturer Saebo received FDA clearance for its SaeboVR rehab system.
The proprietary platform engages clients in physical and cognitive challenges involving daily functional activities, using a virtual assistant that appears on the screen to provide real-time feedback.
The Charlotte, NC, company’s system exercises injured or impaired limbs in simulations of daily activities including grocery shopping and preparing meals.
The device can be personalized to alter coordination, timing, speed, endurance and range of motion, and the software issues graphical reports after each session.
CFDA Approves Gilupi CTC Device
The China Food and Drug Administration approved the Gilupi CellCollector, a circulating tumor cell isolation device.
The firm credited its strategic partner and largest shareholder Hebei Viroad Biotechnology for assistance with the CFDA approval. Gilupi plans to launch the product in China using Viroad’s experience with the Chinese market.
The CellCollector was the first in vivo CTC isolation device to secure the CE-mark.
CSA Medical’s trueFreeze Catheter Tech Wins Expanded 510(k) Approval
The FDA awarded 510(k) clearance for an expansion of CSA Medical’s trueFreeze catheter device.
The new approval covers a third spray kit that allows the user to cut the time of liquid nitrogen spray in half, which shortens treatment time. The system is indicated for cryosurgery in dermatological, gynecological and general surgery procedures.
The expansion re-establishes trueFreeze’s approval to treat Barrett’s Esophagus and malignant lesions. The system allows users to deliver liquid nitrogen to destroy cancerous tissues in the esophagus.
FDA Approves EIT’s 3D-Printed Spinal Support Implants
The FDA issued marketing clearance for Emerging Implant Technologies’ 3D-printed titanium spinal support implants.
The German company’s titanium implants are already approved in more than 15 countries. The device is made 80 percent porous, using a selective laser melting process.
The device will enter the market along with competitors. Virginia-based K2M has already secured the FDA’s clearance for its 3D printed lumbar support cage, as has a Stryker 3D spinal implant.
Cardiac Troponin Test Receives CE Mark
Singulex has received the CE Mark for its Singulex Sgx Clarity cTnl assay for the biomarker troponin. The assay is indicated for use in conjunction with a clinical evaluation for ruling out cardiac ischemia in patients suspected of having coronary artery disease.
The company plans to submit data for FDA clearance of the assay in 2018.
Voluntis Secures FDA Clearance, CE Mark for Digital Diabetes Management System
Voluntis received FDA clearance and CE Mark approval to integrate Insulia, its digital diabetes management system, with Sanofi’s Toujeo insulin glargine.
The system uses a patient mobile app and web portal to provide real time insulin dosage recommendations and information.
Voluntis plans to launch the system in the European market in the near future. It is currently working on an extension for the app to include basal insulins and GLP-1 basal insulin combos.
Biotronik Atrial Leadless ICD Line Scores FDA Approval
The FDA approved Biotronik’s Intica DX and Intica CRT-DX implantable defibrillator systems.
The Intica device line is the first that does not require an atrial lead because it provides atrial signal information. The systems remove several of the risks and complications associated with implanting cardiac resynchronization therapy devices.
The new device also incorporates the German company’s MultiPole Pacing technology, which allows two pacings per cardiac cycle for the left ventricle.
Masimo Scores CE Mark for RPVi Device
Masimo was granted CE Mark approval for its multi-wavelength version of the Pleth Variability Index for monitoring changes in fluid volume.
The approved device, the RPVi, is a noninvasive continuous measurement device that monitors changes in the perfusion index during respiratory cycles. The changes can reflect physiologic factors ranging from vascular tone to circulating blood volume.
The company recently received CE Mark approval for its Rainbow Super DCI-mini sensor, a reusable spot-check sensor with multiple physiologic measurements.
FDA Clears DarioHealth’s Glucose Meter and App
DarioHealth secured 510(k) clearance from the FDA for its combination glucose meter and app for Android devices.
The pocket-sized meter device syncs with a companion app, available on Android and iOS devices, which includes a nutrition guide and log. Users can view the raw data as well as patterns and trends.
Since receiving FDA clearance in December 2015, DarioHealth has marketed the product in the U.S. exclusively for the Apple iOS 6.1 platform and higher.