Devices
FDA has cleared an Anika Therapeutics 510(k) for the Integrity Implant System, intended for use in augmenting an injured tendon to promote healing in rotator cuff repair procedures. “Clearance of the hyaluronic acid (HA) based patch component joins the prior 510(k)s received for the associated fixation devices
Devices
FDA has updated its list of ultraviolet (UV) wand products that may present a potential risk of injury. Last year, the agency issued a safety warning about the use of certain brands of UV wands because the devices may expose users and any nearby people to unsafe levels of ultraviolet-
Devices
FDA has cleared a GE HealthCare 510(k) for its Portrait Mobile wireless and wearable monitoring device, which GE says allows real-time continuous monitoring with a personalized view of the patient’s vitals while keeping patients mobile during critical recovery periods. “Continuously monitoring patients and having a real time
Drugs
Medical device recall events fell 4.4% in the second quarter of 2023 from 252 in the first quarter to 241, according to the latest Sedgwick Recall Index. Meanwhile, the index says, drug recall events fell 6.3% from 144 in the first quarter to 135 in the second quarter.
Devices
FDA has cleared a Pentax Medical 510(k) for its Inspira 4K video processor and the i20c video endoscope. The company says the video processor is controlled using a “customizable, state-of-the-art touch panel, equipped with innovative image enhancement functionalities and 4K image processing.” The device also features
Devices
FDA says the Datascope/Maquet/Getinge 6/5 recall of Cardiosave Hybrid and Rescue intra-aortic balloon pumps for printed circuit board assembly failures is Class 1. An agency notice says the company recalled 4,586 devices distributed in the U.S. between 5/6/2012 and 5/19/2023.
Devices
FDA has granted BlueWind Medical a de novo marketing authorization request for the Revi System, a tibial neuromodulation therapy for treating the symptoms of urgency incontinence alone or in combination with urinary urgency. The authorization was based on results from the OASIS pivotal trial, in which the device demonstrated a
Devices
CDRH says it prefers public comments on its guidance documents that are submitted in a “table format” because it facilitates the Center’s analysis and compilation of comments received. This preference is suggested in a new CDRH Web page on “Tips for Submitting Comments on CDRH Guidance Documents.” The table
Devices
FDA has cleared a CathVision 510(k) for the PVI Analyzer and Signal Complexity algorithms as part of the Cardialytics suite of artificial intelligence (AI)-powered analytics integrated into the ECGenius System, an electrophysiology (EP) recording system. The AI algorithms are intended to assist in electrogram interpretation to help physicians
Devices
A 3/1-5/17 FDA inspection at TEI Biosciences in Boston, MA, an Integra LifeSciences company, found Quality System (QS) regulation violations in the firm’s manufacturing of collagen-based medical devices, such as Durepair, used for wound care, soft tissue repair, and reconstruction surgery. A just-released 7/
Devices
FDA has granted AngioDynamics a breakthrough device designation for its AngioVac System and its proposed indication for use to include the non-surgical removal of vegetation (lesions) from the right side of the heart. The AngioVac System is described as an on-circuit aspiration system that uses a venous drainage
Devices
Philips Respironics is recalling (Class 1) its Trilogy Evo, Evo O2, EV300, and Evo Universal ventilators after detecting dust and dirt in the air path of some devices. “Extended exposure to environmental contaminants such as dust and dirt can lead to buildup that may block air vents and cause the
Devices
FDA has released a final guidance entitled “Off-The-Shelf Software Use in Medical Devices” that recommends documentation sponsors should include in premarket submissions. The document describes information that would be typically generated and documented during software development, verification, and validation. Off-the-shelf (OTS) software is commonly used in
Devices
FDA has cleared a Ceribell 510(k) for its new software ClarityPro for diagnosing electrographic status epilepticus (ESE) in adults. “The ability to diagnose ESE is essential to treating prolonged seizures, which may affect one-third of neurological critical care patients during their hospital stay,” the company says. “These seizures
Devices
FDA has issued a warning to not use 15 tests manufactured by Reno, CA-based Universal Meditech after the company notified the agency that it has stopped all operations and is no longer providing support for its tests. An FDA notice says it is not able to confirm the performance
Devices
FDA has updated the Catalog of Regulatory Science Tools to Help Assess New Medical Devices by adding four new tools and updating nine tools. The catalog provides a peer-reviewed resource for medical device companies to use where standards and qualified medical device development tools (MDDTs) do not yet exist,
Devices
Datascope/Maquet/Getinge is recalling the Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps because they may shutdown without warning due to electrical failures in the power management board or solenoid board. Using an affected device may cause serious adverse health events, including unstable blood pressure, injury, and death, according
Devices
FDA has cleared an Accuray 510(k) for its VitalHold breast cancer package and its use on the company’s Radixact radiation therapy system. VitalHold allows “deep inspiration breath hold (DIBH) treatments” using Radixact’s fixed beam angle delivery mode (TomoDirect) and a fully integrated and automated surface-guided radiation
Devices
FDA has approved a ZimVie PMA supplement for a smaller height of its Mobi-C Cervical Disc in seven sizes to address the anatomical needs of diverse patients. “The 4.5mm height implants are an important addition to the Mobi-C lineup,” a company release says. “Surgeons will be able
Devices
FDA has cleared a Curiteva 510(k) for the Navigation Instrument System for use with its Prodigy Pedicle Screw System and SI-Lution Sacroiliac Joint Fusion System. The company says it designed the instruments to integrate seamlessly with its navigation system that assists surgeons in locating anatomical structures during surgical
Devices
CBER says it is now beginning a phased implementation of in-person industry meetings with device manufacturers. “At this time, CBER will limit in-person meetings to Submission Issue Requests,” according to an agency notice. Now that CBER staff have begun returning (post-pandemic) to work at its White Oak,
Devices
FDA has approved a Boston Scientific PMA for the POLARx Cryoablation System for treating patients with paroxysmal atrial fibrillation (AF). The device features the POLARx FIT Cryoablation Balloon Catheter, which allows two balloon sizes – 28mm and 31mm – in one catheter. “The system addresses known limitations by reimagining existing cryoablation offerings,