Approvals

Cardiologs Technologies’ ECG Analysis Platform Scores 510(k) Approval

The FDA has awarded 510(k) approval to Cardiologs Technologies’ ECG analysis platform.

The platform uses cloud-based cardiac monitoring and analysis web service to analyze long-term ambulatory ECG monitoring recordings. The system has already secured the CE Mark in the European Union.

The technology will allow cardiologists to recover digital ECGs from any compatible monitoring device and, after uploading them to the cloud, use the Cardiolog technology to identify relevant cardiac events.

Cerus Gets CE Mark for Intra-Cranial Aneurysm Device

Cerus Endovascular received the European Union’s CE Mark for its Contour Neurovascular System. The device is used to treat intra-cranial aneurysms through an implant.

Cerus is currently conducting a 45-patient single-arm trial to demonstrate the device’s safety in treating unruptured aneurysms, with the research taking place at four neurological centers in the United Kingdom and one in Hungary.

The Contour system will receive a limited commercial rollout in the third quarter of this year.

FDA Reduces Clinical Trial Endpoint for Angioplasty Device

Intact Vascular announced the FDA approved its request to alter the primary endpoint in a clinical trial for its new angioplasty device from12 to six months.

The multi-center, single-arm study aims to investigate the safety and efficacy of Intact’s Tack device, an endovascular system designed to repair tears in the artery wall, a frequent balloon angioplasty complication. The company is sponsoring three clinical trials, enrolling the first patient in February.

Pinnacle Spine Group Receives a Fourth Patent for Graft Device

Pinnacle Spine Group received a U.S. patent for its in situ graft delivery technology.

The patent applies to the company’s system for delivery of graft material to the chamber of a spinal fusion device. The company has previously received three patents covering the same fusion technology and owns several non-U.S. applications, including in Europe, Australia and Canada.

The devices enable targeted in situ placement of bone graft material directly into the implanted device for maximum contact with the vertebral endplates.

Z-Medica Gets FDA Clearance for Internal Bleeding Control Device

The FDA awarded de novo clearance to Z-Medica’s QuickClot Control+ device.

The device is indicated for temporary control of internal organ space bleeding for patients with Class III or IV bleeding, according to the Wallingford, Conn., company. Preclinical trials for the device, they said, showed the device led to significantly less blood loss compared to packing with laparotomy sponges.

The approval comes seven months after the company reached a three-year deal to supply the New York Police Department with its QuikClot belt trauma kits.