Devices
FDA has cleared a RedDress Ltd 510(k) for its RD1 system, a device that allows health care providers to produce in real time in vitro whole blood clots for use in wound care. “Under the supervision of a healthcare professional, the whole blood clot produced by the RD1 System
Devices
FDA has cleared a Visura Technologies 510(k) for its TEE Camera Assist Device, a single-use disposable camera that attaches to a transesophageal echocardiogram (TEE) ultrasound probe allowing physicians to view the upper airway and esophagus during probe placement for safe intubation. Physicians currently place TEE probes blindly, guided
Devices
CDRH director Jeffrey Shuren says the agency has led a working group of regulators from several countries under the auspices of the International Medical Device Regulators Forum (IMDRF) to establish basic policies for a new, pragmatic, and internationally harmonized regulatory framework for software as a medical device (SaMD) that better
Drugs
Two Hyman, Phelps, and McNamara attorneys say the Justice Department (DoJ) is quietly implementing a policy asking that various law enforcement entities appropriately coordinate in imposing penalties on a company, to “avoid the risk of repeated punishments that may exceed what is necessary to rectify the harm and deter future
Devices
FDA has cleared an IsoRay 510(k) for its GammaTile brachytherapy technology that uses proprietary Cesium-131 seeds within customizable collagen-based carriers for treating recurrent brain tumors. The therapy “leverages Cesium-131’s unique ability to deliver a highly targeted dose of intense radiation treatment while limiting radiation exposure
Devices
FDA has cleared an Arthrosurface 510(k) to market the Patellofemoral WaveKahuna Arthroplasty System. The implants are intended to restore the articular surface geometry of the patella and femoral trochlea while maintaining a patient’s native anatomy, according to the company. Their extended lateral aspect and trochlear geometry are designed
Devices
FDA has cleared a Renovis Surgical Technologies 510(k) for the Tesera SA Hyperlordotic ALIF Interbody Spinal Fusion System. The porous titanium stand-alone anterior lumbar interbody fusion system features a four-screw design and a locking cover plate to prevent screw backout, according to the company. All implants utilize
Devices
FDA has cleared an Embolx 510(k) for its next generation Sniper Balloon Occlusion Microcatheter, intended for use for pressure-directed arterial embolization therapy. The device is available in three lengths — 110 cm, 130 cm and 150 cm — to allow interventional radiologist physicians to access either femoral or radial arterial
Devices
FDA has permitted the de novo marketing of Fresca Medical’s Curve Positive Airway Pressure delivery system for treating obstructive sleep apnea. The device includes a dedicated flow generator, a lightweight and ergonomic air delivery hose, and a nasal pillow patient interface. According to Fresca Medical, it features the company’
Devices
FDA has cleared a Beckman Coulter Diagnostics 510(k) for its new high-sensitivity troponin assay, Access hsTnI, for use on the Access 2, DxI and all Access immunoassay systems. The assay is intended to detect troponin I, a protein that is present in circulation during myocardial infarction. The test
Devices
FDA has approved a Glaukos Corp. PMA for the iStent inject Trabecular Micro-Bypass System, indicated for reducing intraocular pressure in adult mild-to-moderate primary open-angle glaucoma patients undergoing concomitant cataract surgery. The device is designed to “optimize the natural physiological outflow of aqueous humor by creating two
Devices
FDA has cleared a Zetta Medical Technologies 510(k) for its Zoom software, an MRI software algorithm for image quality enhancement and image optimization of short scanning techniques. The company says the software is vendor neutral and works with all MRI models from all major manufacturers. It uses the standard
Devices
Draeger Medical Systems has begun a Class 1 recall of its Jaundice Meter JM-103 and JM-105 models which are used to measure bilirubin in newborn infants. The meters are being recalled because users have misinterpreted display messages, resulting in serious injuries. Some users have interpreted the display messages
Devices
FDA has permitted the de novo marketing of two catheter-based devices designed to create a connection to veins and arteries in patients with chronic kidney disease who need hemodialysis. The devices, Avenu Medical’s Ellipsys Vascular Access System and TVA Medical’s everlinQ endoAVF System, are intended for use
Devices
FDA has approved the use of Medtronic’s MiniMed 670G insulin delivery system in patients with Type 1 diabetes seven years of age and older. The device features the company’s SmartGuard technology and Guardian Sensor 3, which work together to automate the delivery of a personalized amount of basal
Devices
FDA has cleared a Tenon Medical 510(k) for the Catamaran Sacroiliac Joint Fixation System, indicated for sacroiliac joint fusion for conditions including joint disruptions and degenerative sacroilitis. The company says the device becomes the first patented single implant sacroiliac joint fusion system using a true posterior approach for minimal
Devices
FDA has approved the Senseonics Eversense continuous glucose monitoring system for use in people age 18 and older with diabetes. The agency says it is the first such device approved with a fully implantable sensor to detect glucose that can be worn for up to 90 days. According to the
Devices
The Justice Department says a federal grand jury has indicted Theranos founder Elizabeth Holmes and the company’s former chief operating officer Ramesh Balwani on two counts of conspiracy to commit wire fraud and nine counts of wire fraud. A department news release says the charges stem from allegations that
Devices
FDA has cleared a TransMed7 510(k) for the SpeedBird platform of soft tissue biopsy devices. The platform is based on the company’s Zero5 work element that comprises a fused, single element constructed from three hypotubes and forming rotating twin cutter blades. “This element cores, severs, and provides a
Drugs
Several stakeholders are raising issues related to an FDA docket on quality considerations for metered dose inhaler and dry powder inhaler products. The Association for Accessible Medicines, representing generic drug interests, voices three key concerns: industry should be granted a transition period to comply with the new requirements; the agency
Devices
FDA has approved two Grifols blood screening assays: Procleix Ultrio Elite and Procleix WNV. Procleix Ultrio Elite is an assay that allows for increased blood safety by screening and delivering simultaneous results for human immunodeficiency virus Type 1, hepatitis C virus, and hepatitis B virus as well as detecting HIV
Devices
FDA says it is seeking public input and comment on an updated version of its software precertification program working model. An update notice (contains links to the updated working model, the comment docket, and other resources) says the new version outlines these pre-certification program key components: Excellence Appraisal and