FDA warns Staar Surgical again over California plant
February 11, 2015 by Brad Perriello
Staar Surgical said that it received another warning from the FDA over documentation problems at its plant in Monrovia, Calif.
The federal safety watchdog inspected the Monrovia facility from Nov. 14 last year through Feb. 4, finding 10 problems with the way Staar documents product changes and other issues, the company said in a regulatory filing. Read more
Regulatory affairs for medical device startups
February 13, 2015 by Andrew Ahn
Instilling a robust quality management system as soon as possible is crucial in becoming a successful medical device company, writes Regdy blog’s Andrew Ahn. Read more
FDA OKs 2nd phase for Presbia's Flexivue Microlens pivotal
February 13, 2015 by Val Kennedy
Presbia said it received FDA clearance to enroll patients in the 2nd stage of a pivotal study for its Flexivue Microlens for treating presbyopia.
Presbia said it’s continuing to track patients implanted with the lens during the 1st stage of the trial. Read more
FDA approves Pelvalon’s fecal incontinence device
February 16, 2015 by Val Kennedy
The FDA’s Center for Devices & Radiological health granted de novo clearance for Pelvalon’s Eclipse system for the treatment of fecal incontinence in women.
Fecal incontinence is generally caused by damage to the muscles surrounding the anus. Because vaginal childbirth can damage anal muscles and nerves, women are twice as susceptible to the condition as men, according to the agency. Read more
FDA expands indication for Medtronic's Vertex spine implant
February 16, 2015 by Brad Perriello
Medtronic said that it won an expanded indication from the FDA for its Vertex spinal fixation system, covering lateral mass and pedicle screw use in the posterior cervical spine.
Medtronic said the expanded indication makes it 1 of the 1st systems cleared in the U.S. for use of screws at vertebrae C1 to C7. Read more