May 7, 2012

Vol. 9 No. 90

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Lung Assist Maker Warned on Lacking Documentation

Lax documentation of testing failures and inadequate design history files for Novalung’s surgical Lung Assist device have earned the German company an FDA warning letter. Read More

EC Guidance for Notified Bodies on Device Facility Inspections Expected Soon

The European Commission is preparing guidance to assist notified bodies during inspections of facilities where CE-marked medical devices are made. Read More

Devicemaker Issues Device Alert for Surgical Inserter

Pioneer Surgical has issued a field safety notice for its Nubac Trial Inserter – 43-TRL-INSERTER. Read More

Mass. House Repeals the Pharmaceutical and Medical Device Manufacturer Conduct Law

The Massachusetts House of Representatives recently voted on and passed its proposals for the commonwealth’s Fiscal 2013 budget. Read More

Exton Medical Devicemaker to be Sold for $360 Million

Kensey Nash will be acquired by Royal DSM for $360 million. Read More

FDA Lacks System for Tracking Medical Devices That Malfunction

Each prescription drug you take has a unique code that the government can use to track problems. Read More

New HydraSolve Lipoplasty System launched at American Society of Aesthetic Plastic Surgery Meeting

Andrew Technologies launched the HydraSolve Lipoplasty System at the American Society of Aesthetic Plastic Surgery in Vancouver, BC. Read More

Avanquest Mobile Alert Panics for You During Emergencies

Avanquest Software has developed an app that may save lives during emergency situations. Read More