Devices
FDA has cleared a BrainCool 510(k) for the IQool Warm System, intended for use to provide thermal regulation to cool and rewarm adult patients when clinically indicated. The company says the device adds a new feature to its 2017 originally cleared device — to cool patients using its anatomically targeted
Devices
FDA has cleared a Lumendi 510(k) for the DiLumen Is Endolumenal Interventional Scissors, a sterile, single-use, disposable, monopolar electrosurgical device for cutting, dissecting, and cauterizing tissue within the digestive tract during endoscopic procedures. “Adequate tissue manipulation and traction, combined with effective cutting, dissecting and cauterizing, continues to be
Devices
Attorneys Gregory Levine and Abram Barth (Ropes & Gray) say that an FDA 4/27 draft guidance “provides insight into how FDA conceives of its authority to regulate multiple function devices consistent with the 21st Century Cures Act.” They say the document may be useful not only for manufacturers of
Devices
FDA is reminding healthcare professionals involved in surgical procedures about the risk of surgical fires on or near patients. The agency safety notice includes recommended practices to reduce fires from occurring, including the safe use of medical devices and products commonly used during surgical procedures. The notice says that although
Devices
FDA has opened a docket to receive feedback from stakeholders on provisions of the 21st Century Cures Act that exclude certain medical software functions from the definition of a medical device. Under that law, the agency says, Congress excluded specific types of software from FDA regulation, including general wellness software
Devices
FDA has cleared a XableCath 510(k) for its XableCath abrasion tip support catheter for use by interventionalists in managing lesions and procedures in the peripheral arterials. The company says this allows physicians to select between both of XableCath’s designs (blunt or abrasion tips) to slide past an occluding
Devices
FDA has granted Imagen a de novo marketing authorization for its OsteoDetect device, a computer-aided detection and diagnosis software designed to locate wrist fractures in adult patients. The software uses an artificial intelligence algorithm to analyze two-dimensional X-ray images for signs of distal radius fracture, a common
Drugs
A Senate Appropriations Committee 5/24 mark-up for FY 2019 has approved $2.97 billion in discretionary funding for FDA, which is $159 million (5%) over the FY 2018 enacted level, but about $150 million less than the House has approved (see earlier story). Both measures are now awaiting
Devices
FDA has cleared a Mauna Kea Technologies 510(k) for the Cellvizio 100 series F400 and F800 multidisciplinary confocal laser endomicroscopy platform for use during neurosurgical procedures. The device features CranioFlex that provides imaging of tissue internal microstructures and allows the identification of cells and vessels and their organization within
Devices
FDA has cleared a Synedgen 510(k) for its Catasyn Advanced Technology Wound Hydrogel for use under the direction of a health care professional and over-the-counter (OTC) use. When administered by a healthcare professional, Catasyn can be used for dressing and managing partial to full thickness dermal ulcers
Devices
Abbott has recalled its HeartMate 3 Left Ventricular Assist System due to a malfunction in the device’s outflow graft assembly that may cause the outflow graft to twist and close up (occlusion) over time. “Occlusion of the outflow graft can reduce or stop pump flow and set off a
Devices
In a 5/10 Webinar, CDRH staff updated the digital health software precertification pilot program. Center associate director for digital health Bakul Patel went over the Digital Health Action Plan and the steps in the precertification pilot. He said the Center is currently about one-third of the way into
Devices
FDA has cleared a Providence Medical Technology 510(k) for its DTrax Spinal System, indicated for use in posterior cervical fusion in patients with cervical degenerative disc disease. The set of surgical instruments include several specialized single-use devices such as a facet joint access instrument, lateral mass decortication trephine,
Devices
FDA has cleared an Inari Medical 510(k) for the FlowTriever System for treating pulmonary embolism. The clearance is based on data from the company’s FlowTriever Pulmonary Embolectomy (FLARE) clinical study that evaluated the device in 106 patients with acute pulmonary embolism at 18 sites in the U.S.
Devices
Medtronic has recalled its MindFrame Capture LP revascularization device due to wire material that may break or separate during use. The device is intended to restore blood flow or remove blood clots within a blood vessel in the brain during an acute ischemic stroke in patients who are ineligible for
Devices
Federal Register notice: FDA has published a final order to exempt certain surgical apparel from premarket notification requirements, subject to conditions and limitations. FDA is limiting the exemption to single-use, disposable respiratory protective devices used in a healthcare setting and worn by healthcare personnel during procedures to protect both
Devices
FDA has cleared an Additive Orthopedics 510(k) for its Patient Specific 3D Printed Bone Segments for internal bone fixation in the ankle and foot. “Our lattice structures are proving to be the next generation design as opposed to the older, more open, types of structures that rely on biologics
Devices
FDA has cleared a MC10 510(k) for its BioStamp nPoint system, a wireless, biometric data collection platform intended for use by healthcare professionals and researchers for continuous collection of physiological data in the home or traditional healthcare settings. The device is designed for use in clinical trials and research
Devices
FDA has cleared a Ventripoint Diagnostics 510(k) for its VMS+ machine with a four-chamber heart analysis system, intended for use in the analysis of ejection fraction (function) and volumes in any chamber of the heart. “The VMS+ is the first simple echocardiography system to be approved by the
Devices
FDA has cleared a BacterioScan 510(k) for its 216Dx Urinary Tract Infection detection system. The rapid automated diagnostic system uses an advanced laser sensor to detect infections, reducing lab turnaround time to about three hours, an improvement of up to 90% compared with traditional testing approaches, according to the
Devices
FDA has cleared a Caliber Imaging & Diagnostics 510(k) for modifications to its Vivascope System, a reflectance confocal microscopy (RCM) device that allows dermatologists to visualize cellular structures within the skin. The device provides high-resolution RCM images of the epidermis down to the supporting stroma in thin, optical
Devices
FDA says currently available objective evidence is not sufficient to conclude whether there is a widespread public health concern related to servicing of medical devices that would justify imposing additional or different burdensome regulatory requirements at this time. That position is stated in a 5/2018 agency report on the