Devices
The HHS Office of Inspector has posted a corporate integrity agreement between the government and Minneapolis-based Cardiovascular Systems Inc. (CSI) that follows an $8 million fine the company paid to resolve alleged illegal kickbacks to induce physicians to use its medical devices. The government alleges that CSI violated the
Drugs
In November, FDA has planned a two-day public hearing to obtain input on off-label communication by drug and medical device companies. An FDA notice says the agency is “engaged in a comprehensive review of its regulations and policies governing firms’ communications about unapproved uses of approved/cleared medical
Devices
FDA has cleared a Siemens 510(k) for the Somatom Drive computed tomography system, a new dual source scanner designed to deliver more precise imaging while reducing patient dose exposure. The device is equipped with the company’s Straton MX Sigma X-ray tubes and Sigma generators, which allow for
Devices
Sens. Chuck Grassley (R-IA) and Elizabeth Warren (D-MA) have asked the Accredited Standards Committee X12 about steps it is taking to include medical device unique device identifiers on health insurance forms. “Collecting device identifiers on insurance claims forms would allow device performance and safety concerns to be tracked
Devices
The 5th Circuit Court of Appeals has upheld a Mississippi federal court’s grant of summary judgment to Lanx Inc. in a state law suit involving its Telluride system. A patient in whom the system was implanted to fuse spinal vertebrae filed the suit after screws in the system fractured
Devices
A 6/17-7/7 FDA inspection at Simpro, Irving, TX, found Quality System Regulation and Medical Device Reporting violations in the firm’s importing and distributing of non-invasive blood pressure monitors, fingertip pulse oximeters, and portable fetal Dopplers. An 8/17 Warning Letter from the agency’s Dallas
Devices
FDA has released a final guidance on “Enforcement Policy on National Health Related Item Code and National Drug Code Numbers Assigned to Devices.” The guidance describes the agency’s enforcement of a prohibition against providing National Health Related Item Code or National Drug Code numbers on device labels and device
Devices
Cook Medical has begun a Class 1 recall of its Roadrunner Uniglide Hydrophilic Wire Guide due to potential coating contamination with glass particles. The devices are constructed from a steerable, metallic core with a polymer coating, and a hydrophilic coating is applied over the radiopaque polymer jacket, according to a
Devices
CDRH plans to improve medical device review consistency and predictability during the next user fee cycle (FY 2018-2022) through “enhanced supervisory oversight and routine quality audits,” according to just-posted minutes of an 8/15 user fee negotiation meeting that agreed to a draft commitment letter (see earlier story)
Devices
In a safety communication to healthcare professionals, FDA says that when using programmable syringe pumps to infuse therapies at low rates (less than 5 mL per hour and especially less than 0.5 mL per hour), an inconsistent rate of delivery can result in serious clinical consequences, including delay of
Devices
FujiFilm Medical Systems has submitted the final PMA module for its digital breast tomosynthesis, an optional software upgrade for the Aspire Cristalle digital mammography system. The upgrade includes the company’s hexagonal close pattern detector pixel design, which is designed to “enhance detail for improved low dose performance compared to
Devices
Columbia University College of Physicians and Surgeons researchers say that among women who underwent minimally invasive hysterectomy from 2013 to the first quarter of 2015, power morcellation was used in 13.5% in the first quarter of 2013, peaked at 13.7% by the fourth quarter of that year, and
Devices
A citizen petition filed on behalf of five individuals who were damaged by electroshock therapy (also known as electroconvulsive therapy or ECT) asks FDA to either ban use of the devices or keep them in Class 3 and set a date for premarket approval for all such devices. The petition
Devices
FDA has cleared an Amedica 510(k) for expanded Valeo II Lateral Lumbar sizes. The interbody fusion device is made of the company’s proprietary medical grade silicon nitride ceramic. The recently cleared sizes allow for a wider range of patient anatomies as well as “greater stability as the shape
Drugs
The Stericycle Recall Index for the second quarter of 2016 shows that drug recalls are up from the first quarter, but still well below historical trends dating back to 2004. Recalls rose 35% to their highest level since the third quarter of 2014, the report says. And recalled units increased
Devices
A Centers for Disease Control (CDC) study shows that 25% of reports to the FDA Medical Device Report (MDR) database on problems with contact lenses involved patient behaviors that could be modified to reduce the risk of eye damage. The report says that during 2005-2015, a total of 1,
Devices
bioMérieux has submitted line-by-line technical comments to FDA requesting clarifications to the agency’s draft guidance on the form and content of a medical device unique identifier. The submission comments on language in four sections of the draft.
Devices
SRS Medical Systems has gained IDE approval to enroll patients in a study to expand the indications for use for its Spanner Temporary Prostatic Stent. The stent is an alternative to both indwelling (Foley) and intermittent urinary catheters in male patients, according to the company. Currently, it is approved for
Devices
FDA has cleared a Bio2 Medical 510(k) for the Angel Catheter, intended for use in preventing pulmonary embolism (PE) in patients who cannot take anticoagulation therapy. The device provides an alternative to inferior vena cava (IVC) filters for PE protection, according to the company, and it is designed for
Devices
FDA and the medical device industry have reached an agreement in principle on the next round of user fees that will see fees skyrocket by about $400 million (67%) over the next five years beginning 10/1/2017. This is the fourth reauthorization of the medical device user fee program,
Devices
FDA has published a guidance, Patient Preference Information — Voluntary Submission, Review in Premarket Approval Applications, Humanitarian Device Exemption Applications, and De Novo Requests, and Inclusion in Decision Summaries and Device Labeling, explaining the principal concepts for sponsors and other stakeholders to consider when choosing to collect patient preference information (PPI)
Devices
FDA is proposing to amend the good laboratory practice (GLP) regulations for non-clinical laboratory studies to require a GLP Quality System approach when safety and toxicity studies support or are intended to support applications or submissions for FDA regulated products. A Federal Register notice says the agency also is