Devices
FDA has approved Abbott’s HeartMate 3 Left Ventricular Assist Device (LVAD) as a destination therapy for people living with advanced heart failure. The device uses the company’s Full MagLev (fully magnetically-levitated) Flow, which reduces trauma to the blood passing through the pump while improving flow, the company
Devices
FDA has issued Ocular Therapeutix a 10/17 Warning Letter over the company’s compliance with data collection and information reporting obligations in a post-approval device exposure registry study required as a condition for PMA approval for ReSure Sealant. The company says it is required to provide periodic reports
Devices
A 10/10 CDRH Webinar explained the Quality in 510(k) (Quik) Review Program that provides an alternate method to submit a 510(k) to FDA using the eSubmitter software to format the submission. CDRH biomedical engineer Angela DeMarco said the purpose of the Quik pilot program is to simplify
Devices
Three medical device stakeholder groups have asked FDA to consider additional medical device accessories for reclassification into Class 1. AdvaMed said in a comment letter that it agrees with the down-classification of the devices and associated product codes listed in an FDA notice requesting comment, and believes there are
FDA Policy/General
Current CDRH surveillance and enforcement concerns involving promotional or adverting efforts include unapproved devices (no approval, clearance, or exemption), modified devices (formerly legally marketed but with no approval or clearance for modification), and unapproved/uncleared indications or intended uses. Speaking at a Food and Drug Law Institute conference 10/17
Devices
FDA has cleared an MC3 510(k) for the Crescent Jugular Dual Lumen Catheter for use in extracorporeal membrane oxygenation (EMCO). The device is placed through the jugular vein and is connected to an ECMO system, which removes carbon dioxide and reinfuses oxygenated blood, according to the company. The dual
Devices
FDA has cleared a CoreLink Surgical 510(k) for the M3 Stand-Alone Anterior Lumbar (ALIF) System. The M3 system is a sterile packed, three-screw, integrated fixation device for ALIF procedures, featuring a universal bi-directional design with a simple and intuitive locking mechanism, the company says. The 3D-
Devices
FDA says it has signed a Memorandum of Understanding with the Department of Homeland Security (DHS) to implement a new framework for greater coordination and cooperation between the two agencies to address medical device cybersecurity. FDA commissioner Scott Gottlieb says the strengthened partnership with DHS “will help our two agencies
Devices
The Kidney Health Initiative, a public-private partnership between the American Society of Nephrology, FDA’s CDRH, academia, industry, and patient groups, intends to advance scientific understanding of kidney health and foster development of therapies for kidney diseases. The group’s Regulatory Considerations Affecting Device Approval project was designed to:
Drugs
FDA has outlined a three-factor approach it uses to evaluate whether a drug- or device-related product communication is consistent with the product’s agency-required labeling. The factors come on the heels of a related guidance entitled Medical Product Communications That Are Consistent With the FDA-Required Labeling
Devices
TearLab Corp. says FDA has rejected a 510(k) for its TearLab Discovery MMP-9 test for dry eye disease, and found that the device did not meet the criteria for substantial equivalence based upon data and information submitted by the firm. The agency provided guidance to the company and
Devices
FDA has classified as a Class 1 recall an Endologix safety notice to healthcare professionals about its AFX Endovascular AAA [abdominal aortic aneurysm] System and the risks associated with Type III endoleaks. The device is indicated for treating abdominal aortic aneurysms. When a Type III endoleak occurs, blood continues to
Devices
FDA has cleared a Civco Radiotherapy 510(k) for its Solstice SRS Immobilization System. The device offers “corrective pitch capability and positioning flexibility,” according to the company. It features customizable components to immobilize the patient’s head and neck during radiotherapy. The system comprises a carbon fiber head support, customizable
Devices
FDA has approved Grifols’ ID Core XT molecular diagnostic test for blood group genotyping. “Molecular red blood cell typing provides significant advantages to patient and in donor management,” the company says, adding that individuals requiring frequent transfusions are at a higher risk of receiving incompatible blood, which can result in
Devices
FDA has cleared a FibriCheck 510(k) for its smartphone application that monitors heart rhythm disorders by using an optical signal originating from a smartphone. The app uses a smartphone camera or the optical sensors of a smartwatch to detect heartbeats and derive a heart rhythm, according to the company.
Devices
FDA should require high-quality evidence that meaningful clinical benefits exceed risks for medical devices. That’s the conclusion of a Health Affairs blog post by University of California San Francisco cardiologist Rita Redberg that explores lessons learned from the 2017 ORBITA study that found that coronary stenting did not
Devices
FDA has issued a safety alert following a Medtronic software update to address a risk caused by cybersecurity vulnerabilities associated with an Internet connection between its Carelink 2090 and Carelink Encore 29901 Programmers that are used to download software for the company’s cardiac implantable electrophysiology devices. FDA says the
Devices
Cardiac surgeon and anti-power morcellator activist Hooman Noorchashm is petitioning FDA to ban the use of “uncontained” laparoscopic power morecellator devices in gynecological operations involving resection of the uterus and its associated tumors. The 10/9 petition says recent epidemiological data from Yale University demonstrated that 2%-10% of
Devices
FDA has awarded $5 million to the National Capital Consortium for Pediatric Device Innovation (NCC-PDI), led by Children's National Health System and University of Maryland, College Park. The grant is intended to foster development, production and marketing of the next generation of medical devices designed to meet
Devices
FDA has cleared a Transseptal Solutions 510(k) for the TSP Crosser Transseptal Access System, a transseptal puncture system with a built-in steering mechanism, indicated for use in procedures where access to the left atrium via transseptal technique is desired (e.g., mitral valve repair or replacement, paravalvular leak
Devices
Hogan Lovells attorneys say that a 9/28 FDA draft guidance, The Special 510(k) Program, “introduces a different, more expansive standard for assessing which devices are eligible for review under the program.” In an online post, the attorneys say the modified standard may enable medical device manufacturers to obtain
Devices
Sens. Elizabeth Warren (D-MA), Patty Murray (D-WA), and Tina Smith (D-MI) have raised concerns about CDRH’s regulation of digital health devices and the Center’s “Pre-Certification for Software Pilot Program,” which is part its broader effort to modernize the regulatory approach to digital health devices.