FDAnews Device Daily Bulletin

Johnson & Johnson’s (J&J) upcoming CEO switch, from Bill Weldon to devices business head Alex Gorsky, could signal the company’s confidence in its ongoing relaunch of McNeil Consumer Products, an analyst says.

Addison, Ill.-based Anchor Products received a Form 483 with repeat observations on medical device reporting (MDR) procedures and handling of customer complaints.

Salter Labs is issuing a recall for the 7600 Bubble Humidifier, 350cc volume with 6PSI safety valve, on reports that lids failed to pop off at the intended pressure.

Steven Baker’s artificial elbow locked up as he was going through a metal detector at a Senate office building recently.

MedSolutions praised President Obama’s 2013 budget, which would require prior authorization for advanced imaging services, such as CT, MR and PET scans, provided through Medicare.

Restoration Robotics announced that its revolutionary Artas System has received a Canadian Medical Device License and can now be marketed and sold within Canada.

Hip implants, knee replacement devices, and vaginal and hernia mesh products are the latest defective medical devices that have caused serious injuries in patients.

New Thermobalancing Therapy treats kidney stones disease and dissolves kidney stones in one and both kidneys without medication or removal procedure.

Texas Instruments and Aricent announced their collaboration on a small cell protocol stack optimized for TI’s KeyStone-based multicore System-on-Chips.