Industry News

Both, ATS medical and St Jude Medical have announced new cardiac ablation systems. St Jude Medical has a CE Mark and FDA clearance for the Epicor LP cardiac ablation system, a second generation technology that uses high intensity focused ultrasound to surgically ablate cardiac tissue to disrupt abnormal electrical impulses in the heart. Whilst, ATS Medical has received ISO certification for its Quality System to manufacture and CE Mark CryoMaze cardiac ablation products.

Draeger Medical has received FDA clearance for the Draeger Fabius magnetic resonance imaging anaesthesia machine. The anaesthesia machine is said to be designed specifically to meet the requirements for the magnetic resonance imaging (MRI) environment.

3M has introduced two new particulate respirators for use by the general public in public health medical emergencies. The FDA outlined a special clearance process for N95 respirators to provide reasonable assurance of their safety and effectiveness.

St Jude Medical has said that it has received FDA approval for the company’s new facility in Puerto Rico, for manufacturing pacemakers and cardiac leads. The 150,000 square-foot facility will produce for domestic and international markets, and the company plans to begin manufacturing implantable cardioverter defibrillators at the facility later this year.

Prosurgics has established a US organization and appointed Bill Perry as its president.

The FDA has amended its rules regarding, Supplemental Applications Proposing Label Changes For Approved Drugs, Biologics and Medical Devices. The new rule applies to changes resulting from new information.

Thoracic aortic aneurysm stent grafts have been added to the list of devices subject to tracking requirements, according to a final guidance.

Devices which currently require tracking include:
Temporomandibular Joint (TMJ) prosthesis Glenoid fossa prosthesis Mandibular condyle prosthesis Implantable pacemaker pulse generator Cardiovascular permanent implantable pacemaker electrode Replacement heart valve (mechanical only) Automatic implantable cardioverter/defibrillator Implanted cerebellar stimulator Implanted diaphragmatic/phrenic nerve stimulator Implantable infusion pumps Abdominal Aortic Aneurysm (AAA) stent grafts Silicone gel-filled breast implants Cultured epidermal autografts Thoracic Aortic Aneurysm (TAA) stent grafts Breathing frequency monitors Continuous ventilators Ventricular bypass (assist) device DC-defibrillators and paddles.

EN ISO 23328-2:2008 Breathing system filters for anaesthetic and respiratory use Non-filtration aspects. Breathing apparatus Medical breathing apparatus Respirators Anaesthetic equipment Air filters Filters Leak tests Flow measurement Packaging Marking Instructions for use.

EN ISO 24157:2008 Ophthalmic optics and instruments. Reporting of aberrations of the human eye. Ophthalmology Eyes Human body Defects Optics Optical properties of materials Coordinates (mathematics) Wave properties and phenomena Mathematical calculations Optical measurement Ophthalmic equipment.

ISO EN 60601-2-37:2008 Medical electrical equipment Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment Medical equipment Electrical medical equipment Electrical equipment Electronic equipment and components Safety engineering Electrical safety Safety measures Ultrasonic medical apparatus Ultrasonic devices Clinical investigation instruments Performance.