Approvals

Intellijoint Receives FDA Clearance for HIP System

Intellijoint Surgical received FDA clearance for revision total hip arthroplasty with its intellijoint HIP System.

The 3D mini-optical navigation system allows surgeons to evaluate existing arthroplasty components to make precise measurements for cup position, leg length and offset.

The device is indicated for use with Medacta’s GMK Revision and GMK Hinge Knee systems, as well as the GMK tibial extension stems and offset.

FDA Clears Complete Blood Cell Count Analyzer

The FDA has granted premarket clearance and a waiver under the Clinical Laboratory Improvement Amendments of 1988 to Sysmex America for its complete blood cell count test.

Broadened access to the XW-100 automated hematology analyzer for patients at least 2-years-old in additional healthcare settings such as non-traditional laboratories, will allow for faster availability of results, the agency said.

The analyzer provides results from a complete blood count test more quickly than the standard 24-hour delivery.

Grifols Wins FDA Approval for Fibrin Sealant

Grifols won the FDA’s approval for its Fibrin Sealant for surgical use in adults, the company announced in a Securities and Exchange Commission filing.

The device is composed of the plasma proteins fibrinogen and human thrombin.

Grifols said the U.S. approval will allow it to expand its range of plasma-derived products. The sealant will be manufactured at the Grifols facility in Barcelona, Spain.

Stryker Receives Humanitarian Device Exemption for Neuroform Atlas Stent

Stryker Corporation received FDA approval for the Neuroform Atlas Stent System for marketing under a humanitarian device exemption.

The device is a small nitinol stent that is used in conjunction with metal coils to pack weakened blood vessel sacs in the brain.

The system can be used with neurovascular embolic coils for the treatment of wide neck, intracranial, and saccular aneurysms.

Beckman Coulter Assay Wins CE Mark

Beckman Coulter Diagnostics received a CE Mark for a new high-sensitivity troponin (hsTnI) assay that aids in diagnosing myocardial infarction in patients presenting with chest pain or other ischemic symptoms.

The assay will allow hospitals to develop fast-track protocols leading to early discharge for patients with suspected myocardial infarction, the company said.

The assay can be used with the Access 2, DxI and Beckman Coulter’s family of Access immunoassay systems.

One Drop Receives Regulatory Approval in Canada

One Drop received Health Canada’s approval for its One Drop Chrome, a Bluetooth-enabled blood glucose monitoring system that syncs directly with the One Drop Mobile app.

The system is available as part of One Drop’s Premium and Plus subscription plans.

The device wirelessly transmits blood glucose data directly to the cloud via the One Drop Mobile app for iOS and Android.

DT MedTech Wins FDA Clearance For Ankle Replacement System

DT MedTech’s Hintermann Series H2 total ankle replacement system received 510(k) clearance from the FDA.

The device is indicated for use with bone cement to treat ankle arthritis in either primary or revision surgery of ankle joints damaged by systemic arthritis of the ankle, primary arthritis, and secondary arthritis.

The Hintermann Series H2 is for patients with a failed total ankle replacement or non-union/mal-union of the ankle arthrodesis, if sufficient bone stock is present.