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Fdanewsdevicedailybulletin

Aug. 16, 2012

Vol. 9 No. 161

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Clinical Site’s Problems Won’t Trip Up Launch of First HIV Home Test

An FDA warning letter issued to a researcher involved in clinical trials of the first home HIV test is not expected to affect the product’s marketing, officials from the FDA and the test’s manufacturer said. Read More

Siemens’ Second Warning Letter This Summer Cites Complaint Handling

Siemens Healthcare Diagnostics has received its second FDA warning letter this summer, following an inspection of the company’s Newark, Del., plant. Read More

FDA Provides Draft Guidance on Refuse to Accept Policy for 510(k)s to Replace Existing Guidances

The FDA released a draft guidance, entitled “Refuse to Accept Policy for 510(k)s,” that seeks to clarify and ultimately replace existing policy documents explaining when a medical device premarket notification (510(k)) submission is administratively complete and ready for substantive review. Read More

Medtronic Heart Device Monitor Speeds Care

For a person with a pacemaker or implantable defibrillator, a weekend or evening trip to the emergency room or urgent care can become an hours-long slog of waiting for the “expert” to show up. Read More

Teleflex Buying LMA International for $276 Million

Teleflex agreed to acquire substantially all of the assets of LMA International, a maker of laryngeal masks and other products used in anesthesia and emergency care for about $276 million. Read More

Study: Berlin Heart Device Provides Life-Saving “Bridge” for Children, Babies

A tiny heart pump that maintains blood flow in babies and small children with serious heart failure proved effective and life-saving in a pioneering study involving 17 institutions led by Texas Children’s Hospital and Baylor College of Medicine. Read More

FDA OKs ‘Talking’ Injector

The FDA has approved the first voice-guided epinephrine injection device (Auvi-Q) for treatment of severe allergic reactions. Read More

Use Notebook Studies to Ensure Successful Reusable Device Cleaning Validations

A new management brief from Microtest Laboratories recommends that medical device manufacturers use notebook studies to help ensure successful reusable device cleaning validations. Read More