Approvals

Medtronic Gets Health Canada Clearance for OsteoCool RF Ablation System

Ontario–based Medtronic Canada received Health Canada marketing clearance for its OsteoCool RF ablation system. The cooled radiofrequency ablation device treats patients with bone metastases. The system uses internally water-cooled probes to prevent overheating of surrounding tissue during the procedure.

Galatea Surgical Gains FDA Clearance for GalaForm 3D Plastic Surgery Scaffold

Galatea Surgical, a subsidiary of Tepha, has received FDA marketing clearance for its GalaForm 3D Surgical Scaffold for use in plastic and reconstructive surgery. The device is indicated for soft tissue support to repair, elevate and reinforce soft tissue where weakness or voids exist.

CFDA Approves Venus Medtech’s TAVR Device

China–based Venus Medtech has received approval from the China Food and Drug Administration for its Venus A-valve transcatheter aortic valve system, a less invasive treatment for high-risk patients. The company will launch a global trial for the third generation TAVR device at the end of 2017.

Faxitron Gains FDA Clearance for Radiofrequency Identification System

Arizona–based Faxitron has received FDA marketing clearance for its LOCalizer, a wireless radiofrequency identification breast lesion localization system manufactured by Health Beacons. The tag can be implanted up to 30 days before surgery and is detected by a mobile, handheld reader that accurately locates the tag within millimeters.

FDA Grants Clearance to Medtronic’s Resolute Onyx Drug-Eluting Stent

Medtronic has received FDA approval for its Resolute Onyx drug-eluting stent. The device is introduced through the wrist and allows rapid healing with minimal inflammation and low risk of stent thrombosis.

Teleflex Wins FDA Clearance for AC3 Optimus Intra-Aortic Balloon Pump

Pennsylvania–based Teleflex has won FDA marketing clearance for its AC3 Optimus intra-aortic balloon pump (IABP). The device has received a CE mark and has launched in parts of Europe and India.

GE Healthcare Receives FDA Indication Approval for Imaging Agent

GE Healthcare has received an indication approval from the FDA for its imaging agent Visipaque (iodixanol) injection. The solution is an iso-osmolar agent for use in coronary computed tomography angiography, to assist in the diagnostis of adult and pediatric patients 12 years of age or older with suspected coronary artery disease.

Roche Wins FDA Approval for PD-L1 (SP263) Biomarker Test

Swiss manufacturer Roche has received FDA approval of the VENTANA PD-L1 (SP263) assay as a complementary diagnostic to provide the programmed death ligand (PD-L1) status for patients with locally advanced or metastatic urothelial carcinoma who are being considered for treatment with the FDA-approved anti-PD-L1 immunotherapy Imfinzi. The test is available in the US for use on the BenchMark ULTRA instrument.