Briefs
Medtronic Nabs Clearance for OsteoCool
The FDA has blessed Medtronic with 510(k) clearance for its OsteoCool RF ablation system. Featuring cooled radiofrequency ablation technology, the system uses targeted high-frequency energy to destroy cancer cells. According to Medtronic, the device offers simultaneous, dual-probe capabilities, providing procedural flexibility, as well as predictable, customized treatment. The devicemaker has launched the system in the U.S.
Philips to Introduce Service in Indonesia
Royal Philips has announced the full-scale commercial implementation of its mobile obstetrics monitoring service in West Sumatra, Indonesia, following an agreement with the Sijunjung Regency. A smartphone-based digital health service, the solution aims to identify expectant mothers who are at high risk of pregnancy-related complications. The goal is to reduce maternal mortality rates, Philips says. The solution will be introduced in other regions in Indonesia, India and Africa later this year.
PMAs on Ad Com Meeting Agenda
The FDA’s Circulatory System Devices Panel of the Medical Devices Advisory Committee will vote March 15 on the premarket approval application for Abbott Vascular’s Absorb GT1 bioresorbable vascular scaffold system on March 15. The panel will vote on the PMA application for Angel Medical Systems’ implantable cardiac monitor AngelMed Guardian System the following day. Read the notice here: www.fdanews.com/01-16-FDA-CSDP.pdf.
FDA Postpones Warfarin Monitoring Workshop
The FDA has postponed a workshop on potential solutions to address the scientific and regulatory challenges for a certain type of point of care in vitro diagnostic that monitors warfarin, due to the inclement weather that was forecasted for the Jan. 22-24 weekend. The event, originally scheduled for Jan. 25, will now take place on March 18. The workshop will cover topics associated with prothrombin time/international normalized ratio tests, such as their benefit-risk balance, the current process for clearance and the advantages and limitations of the technology in different devices (IDDM, Dec. 31, 2015).
Japan Gives Thumbs Up to AtriClip Products
Patients in Japan with left atrial appendage occlusion will have new treatment options, thanks to a decision by that country’s Ministry of Health, Labor and Welfare in favor of AtriCure’s AtriClip products. The approval includes the AtriClip Standard and AtriClip Pro devices, which will be distributed by Century Medical. The exclusive distribution agreement runs through 2019, according to AtriCure.
Svelte Launches Stent in Europe
New Providence, N.J.-based Svelte Medical Systems has announced the European launch of its SLENDER sirolimus-eluting coronary stent-on-a-wire integrated delivery system to certain accounts specializing in transradial intervention. The system aims to reduce the catheter size and number of steps necessary to perform percutaneous coronary intervention. It consolidates the guide wire, delivery balloon stent and drug coating technologies into a single, fixed-wire system.