Approvals

Butterfly Network Receives 510(K) Clearance for Chip-Based Imaging System

Butterfly Network received FDA 510(k) clearance for its ultrasound-on-a-chip based imaging system, the Butterfly iQ for iPhone.

The clearance covers 13 clinical applications for a single ultrasound transducer. The technology combines the capabilities of the typical three probes into a single ultra wide-band, 2D matrix array comprised of thousands of microelectromechanical systems.

The artificial intelligence applications are tightly coupled to the hardware to assist clinicians with image acquisition and interpretation.

Abbott Wins CE Mark for XIENCE Sierra Stent

Abbott earned a CE Mark for its XIENCE Sierra coronary stent system.

The device helps cardiologists to access and unblock difficult-to-reach lesions. It features a thin profile, increased flexibility, longer lengths, and small-diameters.

Abbott has submitted an application to the FDA for approval of the device in the United States.

IRadimed Wins 510(k) Clearance of MRI-Compatible Patient Vital Signs Monitor

IRadimed received marketing clearance from the FDA for its 3880 magnetic resonance imaging- compatible patient vital signs monitoring system.

The non-magnetic monitor can be used to transport patients from critical care departments of hospitals to the MRI scanner room and back to critical care without an interruption in vital signs monitoring.

The device has a wireless tablet remote control that allows for the transfer of vital signs information to clinicians.

FDA Clears Atlas Spine’s Expandable Implant

The FDA cleared Atlas Spine’ Ortus implant indicated for restoring patients’ anatomic alignment.

The expandable posterior lumbar interbody system’s starting height (6.5mm) is one of the smallest in the expandable device market.

Surgeons pack graft material after the device is deployed. The Ortus PL is the first implant in a “deep pipeline” of expandable technology it plans on launching, the company said.

Luminex Strep Assay Wins FDA Clearance

Texas-based Luminex received 510(k) marketing clearance for its ARIES Group A strep assay.

The assay detects Steptococcus pyogenes using throat swab specimens. The strep assay is the sixth to receive FDA clearance for use in the ARIES system over the last 24 months.

Medtronic Receives CE Mark for Implantable Spinal Cord Stimulator

Medtronic received the CE Mark for the Intellis platform for both spinal cord stimulation and peripheral nerve stimulation as an aid in the management of certain types of chronic pain.

The device can improve patient-physician communication by tracking and sharing daily activities, body positions and therapy usage and giving physicians an objective view of mobility and progress.

The device is managed on the Samsung Galaxy Tab S2 tablet interface and can record and track patient activity 24/7. It is now available in Europe and the United States.

Abbott’s Mitraclip Approved in Japan as Transcatheter Mitral Valve Repair Device

Abbott received approval from Japan’s Ministry of Health, Labor and Welfare for the company’s MitraClip device for treatment of people with mitral regurgitation, a progressive heart disease in which the mitral valve does not close properly, allowing blood to flow backward into the heart.

The MitraClip system is a catheter-based, minimally-invasive therapy delivered to the heart through a blood vessel in the leg. By securing a portion of the leaflets of the mitral valve with a clip, the heart can pump blood more efficiently throughout the body, relieving symptoms and improving patient quality of life.

MitraClip was approved by the FDA in 2013, after obtaining CE Mark approval in Europe in 2008.

Medacta Wins FDA Clearance for 3DMetal Tibial Cones for Knee Surgery

Medacta received FDA clearance for 3DMetal Tibial Cones for knee revision surgery. The device can be used for structural support in areas of bone deficiencies that may compromise revision implant fixation.

The cones recreate a structural foundation for the intended revision implant by achieving proximal fixation and force transmission in the remaining host bone.