FDAnews Device Daily Bulletin

An FDA final rule with stronger restrictions on the work of disqualified trial investigators takes effect May 30 and nearly mirrors an April 2011 proposed version that received little stakeholder feedback.

China is expected to begin amending its current medical device rules this year, as part of its 12th five-year plan to update its drug and device regulations, according to a panel of China experts at the Food and Drug Law Institute’s annual conference in Washington, D.C.

Abbott Point of Care has issued a recall for some lots of its i-STAT PT/INR cartridges because a potential for INR results to be falsely elevated by approximately 20 percent.

The best doctors strive to relieve their patients’ burdens. A physician in Houston asked Rice University students to help him do so in the most literal way.

Coloplast North America today announced that a federal court jury in Tacoma, Wash., ruled that Generic Medical Devices was infringing on a Coloplast Urology Care patent for the transobturator method for treating stress urinary incontinence in women.

Hitachi Medical Systems America has received clearance from the U.S. Food and Drug Administration to market its Echelon Oval 1.5-tesla ultrawide-bore MRI scanner in the U.S.

St. Jude Medical announced FDA approval of its Ellipse implantable cardioverter defibrillator.

The purchase was undertaken by Angel’s newly-formed and wholly-owned subsidiary, Angel Biomedical.

Interrad Medical announced that it has received FDA clearance for four new sizes of the SecurAcath subcutaneous catheter securement device.