Devices
Medical device cybersecurity vulnerabilities are going to continue to evolve and emerge, and premarket controls are simply not sufficient to manage the threat throughout a device’s lifespan, CDRH associate director for science and strategic partnerships Suzanne Schwartz told a public workshop 1/20 in Silver spring, MD while announcing
Devices
CDRH has posted a guidance on “Implanted Blood Access Devices for Hemodialysis” that provides recommendations for complying with special controls issued as part of a Center device reclassification from Class 3 to Class 2. The devices are intended to provide access to a patient’s blood for hemodialysis. The document
Devices
Biorex Labs is petitioning FDA to exempt devices classified as “Method, Metallic Reduction, Glucose (Urinary, Non Quantitative) in a reagent tablet format from the 510(k) premarket notification requirement. The company’s request says that the device is intended to non-quantitatively or semiquantitatively detect/measure reducing sugars such as
Devices
FDA has sent a Warning Letter to dental device maker DiamoDent (Anaheim, CA) after an inspection last year cited the firm over quality system regulation deviations. The firm makes Class dental prosthetic permanent and temporary implants and abutments. Among the citations in the letter are: 1. Failure to confirm that
Devices
FDA has cleared an Advanced Cooling Therapy 510(k) for the Esophageal Cooling Device for modulating and controlling patient temperature when clinically indicated through a single use, fully-enclosed triple lumen system that is inserted into the esophagus. “Two lumens attach to existing temperature modulation equipment while a third lumen
Devices
FDA director of emergency preparedness, operations, and medical countermeasures Suzanne Schwartz says the agency wants medical device manufacturers and healthcare delivery organizations to incorporate threat monitoring, cyber hygiene for better prevention of attacks, and active responses to identified vulnerabilities. In an online interview with Healthcare IT News, Schwartz says those
Drugs
Six Skadden Arps Slate Meagher & Flom attorneys say the Justice Department appears to be moving away from enforcement actions against off-label promotion practices and toward the financial and commercial relationships between healthcare providers and companies. Writing in an online blog post, the attorneys says that in 2016 they
Devices
A class action suit filed in West Virginia federal court alleges that Boston Scientific participated in an international conspiracy to sell defective vaginal surgical mesh made from counterfeit materials smuggled from China. The suit contains charges under the Racketeering and Corrupt Organizations Act (RICO) on behalf of women who have
Devices
Brainlab has recalled its Cranial IGS System due to potential inaccuracies in displaying the position of surgical instruments relative to the patient anatomy, which could lead to inaccurate, ineffective medical procedures, and serious life-threatening injuries including death. The device shows the area of interest and an instrument’s position
Devices
FDA has cleared an Olympus 510(k) for the TJF-Q180V duodenoscope with modifications to the device’s design and labeling intended to help reduce the risk of bacterial infections. The company intends to recall its original model currently being used in health care facilities and make the needed repair
Devices
FDA Webview’s newsroom will be closed Monday (1/18) in observance of Martin Luther King day. Nightly emails will resume 1/19.
Devices
A new FDA draft guidance is intended to help medical device makers address postmarket management of cybersecurity vulnerabilities. The document outlines important steps they should take to continually address cybersecurity risks to keep patients safe and better protect the public health. It also details the agency’s recommendations for monitoring,
Devices
Barely a week after FDA ordered the reclassification of transvaginal surgical mesh for pelvic organ prolapse (POP) to Class III and the submission of safety-documented PMAs from their manufacturers, an activist claiming to represent thousands of mesh-injured women is urging the agency to recall the devices from the
Devices
FDA has cleared a Conavi Medical 510(k) for the Foresight ICE System for intracardiac and intraluminal ultrasound visualization of cardiac and great vessel anatomy as well as visualization of other devices in the heart and great vessels. The company describes it as the first catheter-based ultrasound system capable
Devices
Cook Group says that while an FDA draft guidance on general considerations for animal studies for medical devices is generally well written and reasonable in terms of the types of controls and level of detail that need to be specified in studies to develop valid scientific data, there are cases
Devices
FDA has cleared a Siemens Healthcare 510(k) for the Sysmex CS-5100 System, a hemostasis system that enables automated, standardized sample management as well as automated detection of unsuitable samples. The company says it’s the first analyzer in its hemostasis solutions portfolio equipped with “simultaneous multi-wavelength Preanalytical
Devices
Recent drug company court victories (see earlier story) against FDA involving First Amendment challenges over off-label promotion did not motivate medical device maker LED Medical to fight a 5/2014 Warning Letter citing certain marketing verbiage on the company’s Web site pertaining to its VELscope Vx system. The
Devices
Attorney Michelle Yeary (Dechert) says a Texas federal court recently rejected a whistleblower’s argument that because FDA has not determined the safety and effectiveness of off-label use of biliary stents used in a vascular stenting procedure, Medicare payment claims for the stents were false. Essentially, she writes in
Devices
CDRH has announced its three strategic priorities for 2016-2017 — establish a National Evaluation System for medical devices; partner with patients; and promote a culture of quality and organizational excellence. The Center says the national medical device evaluation system will “build upon and leverage the vast amount of information and
Devices
FDA has planned a 1/21 Webinar for industry to review a recently released guidance on “Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings.” The guidance describes regulatory requirements and the performance testing needed to support liquid barrier claims for such. It discusses performance standards established
Devices
A report prepared by the Democratic staff of the Senate HELP Committee blasts Olympus and other duodenoscope manufacturers and FDA for cleaning problems with closed-channel duodenoscopes that sickened at least 250 patients worldwide in at least 25 different incidents of antibiotic-resistant infections between 2012 and spring 2015. The
Drugs
Senate Health, Education, Labor and Pensions Committee chair Lamar Alexander (R-TN) says his committee is still planning to move forward its biomedical innovation/FDA reform bill despite the fact that it is a presidential election year. In remarks made before the HELP committee voted on Robert Califf’s nomination