Devices
AdvaMed has submitted its suggested priorities for CDRH’s FY 2016 proposed guidance development. The trade group also submitted recommendations for guidance documents it believes should be part of the Center’s 2016 plans, but are not, along with recommendations on guidances to be updated or withdrawn. For proposed guidances
Devices
FDA says that Argo Medical Technologies has not complied with an agency 6/26/16 order to conduct post-market surveillance (PS) of its ReWalk medical device. A just-released 9/30/15 Warning Letter says the order was issued because the device’s failure to prevent a fall would
Devices
FDA has cleared a Tyber Medical 510(k) for its BioTy, a modified surface treatment for use on its Headless Screw System. “The technology modifies the surface characteristics of medical devices for advanced indications yet to be disclosed, but under development through the FDA review process,” the company says. In
Devices
The Justice Department says that Olympus Corp. of the Americas, the nation’s largest distributor of endoscopes and related equipment, will pay $623.2 million to resolve criminal charges and civil claims relating to a scheme to pay kickbacks to doctors and hospitals. A company subsidiary also will pay $22.
Devices
FDA has cleared an NEC Display Solutions of America 510(k) for the MultiSync MD211G5 medical-grade monitor for use in tomosynthesis applications and full field digital mammography. With a 21-inch display, the five-megapixel, grayscale monitor, which also has been cleared for standard mammography, “offers out-of-the-
FDA Policy/General
A Western Texas jury has found Vascular Solutions and its CEO Howard Root not guilty on all federal charges concerning alleged off-label promotions of the Vari-Lase Short Kit. Senior U.S. District judge Royce Lamberth has entered an order dismissing the case that is final and not subject
Devices
Abbott has begun a Class 1 recall of its MitraClip Delivery System to reinforce the proper procedures used to operate and deploy the device. The company says it has received nine Medical Device Reports where the user was unable to separate the implantable Clip from the delivery system. “Abbott’s
Devices
FDA has ordered Bayer to conduct a postmarket surveillance study on its controversial birth control device Essure as part of its just-released safety review of the product. The study should be designed to determine heightened risks for particular women, the agency says. Additionally, it has released a draft guidance
Devices
The Clinical Decision Support Coalition says FDA is not providing “regulatory clarity” on clinical decision support (CDS) software. A 2/25 white paper from the group says that the agency had identified CDS software guidance a top priority in its 2015 regulatory agenda, but the agency has yet to define
Devices
Former Siemens Healthcare Diagnostics quality management vice president Robin Newman has been selected as CDRH Office of Compliance director, effective 2/22. Newman replaces Steve Silverman, who left the agency a year ago to join McKinsey & Company as a senior expert, medical product quality, compliance, and remediation. Newman has
Devices
The 9th Circuit Court of Appeals has affirmed a California federal court award of summary judgment to Masimo Corp. throwing out a whistleblower suit brought by three former company sales representatives. The whistleblowers had contended that the company violated the False Claims Act by failing to inform FDA that clinical
Devices
FDA has cleared an APN Health 510(k) to market Navik 3D, a cardiac mapping system that is designed to reduce the cost and complexity of electrophysiology procedures. The device is intended to give cardiologists real-time 3D catheter location in the heart from 2D fluoroscopic images and correlate them
Devices
FDA has issued a safety alert on neurosurgical head holders based on medical device reports associated with the slippage or movement of a skull clamp before or during surgical procedures, resulting in more than 700 injuries. device used to secure the patient’s head position during surgical procedures. The system
Devices
At a 1/27 MDUFA 4 reauthorization meeting, FDA presented an integrated proposal combining elements of industry and agency proposals on several topics. Meeting minutes indicate that the agency presented additional details on certain aspects of the proposal and discussed each topic’s importance. Industry agreed to consider the proposal
Drugs
House Appropriations Subcommittee on Agriculture chairman Robert Aderholt (R-AL) balked 2/25 at FDA’s proposed $202 million increase in new user fees for FY 2017. During a budget subcommittee hearing, Aderholt said that while there is a time and place for user fees as demonstrated by the success
Drugs
As part of President Obama’s 2015 Precision Medicine Initiative (PMI), the National Institutes of Health says it is building a national, large-scale, research participant group known as a PMI cohort that will seek to extend precision medicine to all diseases by building a national research cohort of one
Devices
FDA has cleared a Teleflex 510(k) to market its newly designed Arrow VPS Stylet. The new design features a single, double and triple lumen pre-loaded, pressure injectable Arrow Peripherally Inserted Central Catheter with Chlorag+ard technology for use with its current Arrow Vascular Positioning System (VPS) platform. “Together
Drugs
FDA and the Foundation for the National Institutes of Health Biomarkers Consortium are co-sponsoring a two-day workshop on “Developing an Evidentiary Standards Framework for Safety Biomarkers Qualification.” The purpose of the workshop is to discuss the evidentiary standards needed to support biomarker qualification with a particular emphasis on
Devices
Research conducted by University of Pennsylvania Wharton School professors on second and third generation coronary stents supports the FDA position that reductions in medical device approval standards would reduce consumer welfare. But it also supports FDA reform proposals saying that more relaxed premarket requirements and enhanced post-market surveillance would
Drugs
The National Health Council (NHC), which says it represents more than 133 million people with chronic diseases and disabilities and their family caregivers, says that FDA “has made great strides in implementing programs and initiatives across the agency that seek to collect patient perspectives and experiences to inform product reviews.
Devices
FDA has revised a 11/2015 safety communication about Custom Ultrasonics and an agency order to recall all of its Automated Endoscope Reprocessors (AERs) due to the company’s continued violations of a 2007 consent decree. A recent company recall strategy was found inadequate, the agency says, and because it
Devices
FDA medical device reviewers say there are safety issues raised by the Astora Women’s Health TOPAS treatment for fecal incontinence to be considered by the Gastroenterology and Urology Devices Panel at its 2/25 meeting. A briefing document released in advance of the meeting says the device is a