FDAnews Device Daily Bulletin

Proposed Sunshine Act provisions for documenting devicemaker payments to physicians need more context and clarity, industry members say.

Abbott received a Form 483 for “deficiently written or followed” procedures for handling written and oral complaints related to its products.

Sorin CRM received reports in post-market studies that part or all of the fixation helix of the SonRtip endocardial pacing lead with contractility sensor, model No. PS55D, remained in the myocardium after the lead had been removed, leading to a field safety notice from the Medicines and Healthcare products Regulatory Agency.  

1The Food and Drug Administration’s top medical-device regulator said the agency needs more power to block unsafe products and prevent repeats of faulty hip implants and vaginal mesh that sparked thousands of patient lawsuits.

Abbott won expanded pre-market approval from the FDA for its Absolute Pro self-expanding stent system.

Meridian Bioscience received FDA clearance for a test to detect bacteria commonly associated with Legionnaires’ disease.

Representatives of about 20 state medical device trade associations will be in Washington this week to meet with lawmakers to show support for repealing the health care reform law’s medical device tax, among other issues.

Invendo medical announced its 510(k) clearance by the FDA for its C20(TM) colonoscopy system including the SC20(TM) single-use colonoscope.

Researchers have published preliminary data in the Journal of Medical Toxicology on a new device that uses wireless sensors and smartphone technology to provide support for individuals with substance misuse problems or post-traumatic stress disorder.