Devices
FDA has cleared a Sky Medical Technology 510(k) for its geko device for stimulating the calf muscles to prevent venous thrombosis in non-surgical patients at risk for venous thromboembolism (VTE). Previously, the device was cleared for immediate post-surgical stimulation of calf muscles to prevent VTE, increasing blood
Devices
The Justice Department says UTC Laboratories (RenRX), a genetic testing company, and three of its principals will pay $42.6 million to resolve allegations that they violated the False Claims Act by paying kickbacks in exchange for laboratory referrals for pharmacogenetic testing and for furnishing and billing for tests that
Devices
ICU Medical has recalled certain lots of Plum and Sapphire Microbore Infusion Sets with inline filters due to the potential for fluid leaks through air vents on the inline filters. To date, the company has not received any adverse event reports related to the issue, a recall notice says. Fluid
Devices
FDA has issued a guidance, Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings—Labeling Considerations, to provide recommendations for information to be included in the device labeling as submitted in PMAs or 510(k)s for Class 2 and 3 devices. The document is intended to enhance the consistency
Drugs
FDA has issued a guidance, Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination, describing an optional streamlined submission process for determining whether use of an investigational in vitro diagnostic (IVD) in a clinical trial for an oncology therapeutic is considered significant risk, nonsignificant risk,
Devices
A recent FDA policy guidance on medical device software says the agency will exercise enforcement power over three distinct types of software functions, one of which is specifically directed at mobile applications — functions that transform a mobile platform into a regulated medical device by using attachments, display screens, or sensors
Devices
FDA has cleared a Beckman Coulter 510(k) for the DxA 5000 total laboratory automation system. The device is intended to help eliminate preanalytical errors by automatically detecting patient tube parameters such as sample identification, tube type, orders pending and tube weight, the company says. It is designed to focus
Devices
Writing in JAMA Internal Medicine, researchers say they found a substantial misclassification of patient deaths in the FDA MAUDE (manufacturer and user facility device experience) database for the Sapien 3 and MitraClip devices from their approval dates through 12/31/18. The article says the miscategorizations resulted in underreporting of
Devices
FDA has granted Medtronic a breakthrough device designation for its Valiant TAAA Stent Graft System for repairing thoracoabdominal aortic aneurysms (TAAA). The condition causes a bulging of the aorta from the chest down into the abdomen. The investigational device, according to the company, is currently being evaluated in the U.
Devices
Akin Gump attorneys have analyzed a revised FDA clinical decision support (CDS) draft guidance and summarized noteworthy changes in five additional guidances included in a package recently released by the agency to further clarify its interpretation of the 21st Century Cures Act’s software exemptions. The attorneys write that the
Devices
FDA has classified as Class 1 a Medtronic recall of its 6 French Sherpa NX Active Guide Catheter due to a risk of the outer material separating from the device resulting in detached fragments that could result in underlying stainless-steel braid wires being exposed. “These fragments could be left
Devices
Medtronic has filed a PMA supplement for its InterStim Micro neurostimulator and InterStim SureScan MRI leads. InterStim Micro is a rechargeable, implantable sacral neuromodulation device for treating patients affected by overactive bladder, urinary urge incontinence, unobstructed urinary retention and fecal incontinence. The submission for the leads, which are intended to
Devices
FDA has cleared a ProTom International Holding 510(k) for its Radiance 330 proton therapy system, a compact, single room system equipped with an advanced pencil beam scanning system and integrated imaging and control system. The device can be installed within an interior accelerator vault space of 20ft x 30ft,
Devices
United Health Products has submitted a PMA for HemoStyp, an absorbable hemostatic dressing for use in abdominal, cardiovascular, thoracic and vascular surgical procedures. The device is derived from regenerated oxidized cellulose, which is designed to absorb exudate/drainage from superficial wounds, and helps control bleeding. “Once HemoStyp has dissolved in
Devices
FDA has cleared a Biofourmis 510(k) for its machine-learning and artificial intelligence (AI)-powered Biovitals Analytics Engine as a medical device for ambulatory physiological monitoring. The device “receives physiologic data such as heart rate, respiratory rate and activity in near real-time from FDA-cleared sensors and leverages
Devices
FDA has cleared a Turner Imaging Systems 510(k) for its Smart-C Mini-C Arm Portable Fluoroscopy and X-Ray Imaging Device. What makes this device unique is its true mobility and portability. The device weighs 16 pounds, allowing it to be hand-carried to the point of care.
Devices
The International Medical Device Regulators Forum has issued a draft guidance, Principles and Practices for Medical Device Cybersecurity, “to provide fundamental concepts and considerations on the general principles and best practices to facilitate international regulatory convergence on medical device cybersecurity.” The document is intended to provide concrete recommendations to all
Devices
FDA is informing patients, healthcare professionals, IT staff in healthcare facilities, and manufacturers about the Urgent/11 cybersecurity vulnerabilities that, if exploited by a remote attacker, “may introduce risks for medical devices and hospital networks.” An online notice says that Urgent/11 affects several operating systems that may then affect
Devices
FDA has cleared a Luminex 510(k) for the Aries MRSA Assay, a real-time, polymerase chain reaction-based, in vitro diagnostic test for detecting methicillin-resistant Staphylococcus aureus (MRSA) DNA from nasal swabs in patients at risk for nasal colonization. The MRSA assay joins the company’s Aries C.
Devices
FDA has cleared a CivaTech Oncology 510(k) for its CivaDerm, a temporary radiation therapy product designed for intraoperative or surface radiation to treat skin cancer and other lesions. The polymer-encapsulated brachytherapy device can be applied like a bandage to provide a low dose rate brachytherapy treatment for skin
Devices
A new and comprehensive FDA literature review on dental amalgam safety did not find sufficient evidence of a relationship between clinically detectable adverse health outcomes and dental amalgam mercury exposure. Nevertheless, FDA says it will refer the review for discussion at a previously scheduled advisory committee meeting 11/13-14
Devices
FDA has approved Abbott’s Proclaim XR recharge-free neurostimulation system for people with chronic pain. The device provides a low dose of Abbott’s proprietary BurstDR stimulation waveform, which was developed based on scientific input to mimic natural patterns found in the brain, according to the company. “It works