Briefs

FDA Warns of Device Interference Risks

The FDA is warning of reports that breast tissue expanders with magnetic ports may interfere with implantable cardioverter-defibrillators or pacemakers. The interference causes the ICD or pacemaker to enter “magnet mode.” ICDs in magnet mode will not deliver life-saving shocks or anti-tachycardia pacing therapy, which can be life-threatening to the patient if a dangerous abnormal heart rhythm were to occur. When a pacemaker enters magnet mode, the device continuously paces without sensing the patient’s own heart rhythm, which can result in symptoms such as irregular heartbeats, abnormal heart rhythms, or rarely, more serious patient harm. The agency says there is a very small population at risk, as it is generally uncommon for patients with an ICD or pacemaker to have breast reconstruction. Read the letter here: www.fdanews.com/03-16-FDAWarning.pdf.

Australia’s TGA Issues EpiPen Alert

Australia’s Therapeutic Goods Administration is warning of discrepancies on batch numbers and expiration dates for some EpiPen adrenaline auto-injectors produced by Alphapharm. TGA is urging users of the product to check that the expiry date on each EpiPen device is the same as that on the carton, following reports from pharmacies in a small area of Victoria. Read the alert here: www.fdanews.com/03-16-TGAAlert.pdf.

Work Starts on Varian’s Brazilian Facility

Executives, government officials, clinicians and partners gathered for a groundbreaking ceremony celebrating Varian Medical System’s proposed 50,600-square-foot facility in Jundiai, Brazil. The facility — which is expected to be completed in the second half of 2017 — will include a radiotherapy training center, demonstration rooms, manufacturing, warehousing and radiotherapy equipment servicing, the company says. The new facility is part of a partnership between Varian and the Brazil Ministry of Health to improve access to radiotherapy treatment in Brazil and across Latin America.

Roche Wins CFDA Approval for Test

Switzerland-based Roche has gained approval from the China FDA for its CINtec PLUS Cytology test, intended to enhance the detection of human papillomavirus. The approval was based on a study that demonstrated “greater overall performance of combined sensitivity and specificity” of the CINtec PLUS Cytology test in determining which women are more susceptible to developing cervical cancer versus pap cytology, according to the company. The test is now available in China, Europe, Asia, Latin America and Canada.

Hitachi, Redlen to Develop System

Hitachi Medical Corporation has entered into a partnership with Canadian devicemaker Redlen Technologies to jointly develop a direct conversion semiconductor x-ray detector module necessary for new photon counting computed tomography systems, the companies announced. The companies will collaborate to create a multi-energy PCCT semiconductor detector module, with Hitachi exploring diagnostic applications. Redlen manufactures high resolution cadmium zinc telluride semiconductor radiation detectors.