FDA Green Lights Medtronic’s Defibrillators
Medtronic was blessed with FDA approval for the first and only magnetic resonance imaging conditional cardiac resynchronization therapy defibrillators, the company announced. The Amplia MRI Quad CRT-D SureScan and Compia MRI Quad CRT-D SureScan systems are approved for MRI scans on any part of the body without positioning restrictions. U.S. patients who receive these devices — which help treat their heart failure and reduce their risk of sudden cardiac arrest — now will have access to MRI scans if and when they need them. Both CRT-D systems will be commercially available in the coming months.
St. Jude Launches Optis in Europe, Japan
St. Jude Medical has launched its Optis mobile system in Japan and Europe. The diagnostic system is designed to couple optical coherence tomography and angiography co-registration with fractional flow reserve technology for hospitals with multiple catheterization labs. The latest Optis system offers physicians a way to optimize percutaneous coronary intervention procedures to treat vascular disease by combining diagnostic tools designed to improve patient outcomes into a portable device, the company said.
Resonetics Expands to Costa Rica
Resonetics plans to open a new production facility in the Coyol Free Zone Business Park in Alajuela, Costa Rica, the company announced. The new 18,000-square-foot plant will feature a large Class 8 cleanroom, state-of-the-art, ultrafast laser systems and 24/6 operations. The company anticipates that operations will commence in the fourth quarter of this year. “In response to our customers’ need for improved logistics and lower costs, Resonetics is pleased to announce our first factory outside of the United States,” said company CEO Tom Burns.
Jack Voorbrood Joins Qserve Group
Jack Voorbrood has joined global regulatory consultancy firm Qserve Group. He brings 18 years of professional experience as a test engineer of electro-medical equipment and systems. “Jack’s addition emphasizes Qserve’s role in complex regulatory and design engineering projects on active medical devices. We’re excited to further enhance our capacities in this field,” says Gert Bos, executive director and partner of Qserve.
ANVISA to Host IMDRF Meeting
On March 9, Brazil’s ANVISA will play host to a steering committee meeting of the International Medical Device Regulators Forum. Representatives from the forum’s eight members — as well as affiliated organizations and industry representatives — will discuss the regulation of health products industry.
Canada Gives Thumbs Up to AngioDynamics
Health Canada has blessed AngioDynamics’ Celerity PICC tip confirmation system with navigation for the positioning of peripherally inserted central catheters in adult patients, the company announced. AngioDynamics anticipates having the product commercially available during the company’s fiscal fourth quarter.