Devices
FDA has released a suite of guidances “to continue to encourage innovative approaches to the development of digital health tools, and to ensure the agency’s approach to overseeing these technologies advances along with it.” Principal deputy commissioner Amy Abernathy said in a statement that FDA believes that an appropriate
Devices
FDA has cleared a Siemens Healthineers 510(k) for three modules of its AI-Rad Companion Chest CT, a software assistant that brings artificial intelligence to computed tomography (CT). The device helps radiologists interpret images of the thorax (chest) quickly with desired accuracy and precision, and automatically documents these findings
Devices
CDRH director Jeffrey Shuren has told The MedTech Conference in Boston that FDA may be willing to make public which devices are awarded breakthrough designation. He also said he predicts that the number of breakthrough devices getting final marketing approval will spike in about a year. MedTechDive reports online that
Drugs
A systematic review and meta-analysis conducted by researchers from several locations around the world found that the magnitude of treatment effects was some 2.5-fold higher among treatments that were approved based on non-randomized clinical trials (RCTs) than among treatments that required further testing in RCTs. Writing
Devices
FDA has published a draft guidance, Providing Regulatory Submissions for Medical Devices in Electronic Format—Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act, to meet an FDA Reauthorization Act requirement that it issue by 10/1 a draft guidance providing for further standards for the
Devices
FDA has approved Abiomed’s newest heart pump, the Impella 5.5 with SmartAssist, indicated for temporary ventricular support (14 days) and for treating ongoing cardiogenic shock that occurs immediately (less than 48 hours) following acute myocardial infarction or open heart surgery or in the setting of cardiomyopathy. The company
Devices
FDA has granted Aurora Concussion Therapy Systems a breakthrough device designation for its Aurora Light Therapy System for treating concussions. The device applies a near-infrared light to energize the brain’s metabolic cascade process and accelerate the healing process for concussions and other mild brain trauma. The company says
Devices
FDA has approved a Cardiovascular Systems PMA for its ViperWire Advance Coronary Guide Wire with Flex Tip. The device is a combination of a flexible nitinol core with a shapeable floppy tip to help physicians navigate in complex anatomy, the company says. In addition, it says, the flexible nitinol body
Devices
FDA has released a draft guidance entitled “Patient Engagement in the Design and Conduct of Medical Device Clinical Investigations.” The document is intended to help sponsors with how they can use patient engagement to understand experiences, perspectives, and other relevant information from patient advisors. It is also intended to improve
Devices
CDRH is seeking comments on its just-released “Health of Women Program Strategic Plan” that aims to “explore the unique issues related to the performance of medical devices in women, not only in the reproductive health space, but across a woman’s lifetime.” The plan focuses on three priority areas:
Devices
FDA has approved Medtronic’s Evolut Pro+ Transcatheter Aortic Valve Replacement (TAVR) System. The device includes four valve sizes with an external pericardial tissue wrap that provides what the company describes as “advanced sealing for the largest indicated patient treatment range and the lowest delivery profile currently on the market.
Devices
FDA has released a draft guidance entitled Pilot Accreditation Scheme for Conformity Assessment Program that outlines goals, scope, procedures, and a suitable framework for the voluntary pilot, which was mandated by the FDA Reauthorization Act of 2017. The program is intended to support the agency’s continued efforts to use
Devices
Former CDRH director John C. Villforth died 9/14 at the age of 88. Vilforth retired in 1990 after serving 29 years at the agency. He then served as Food and Drug Law Institute president from 1990-2001. Vilforth also helped lead the creation of the Food and Drug Administration
Devices
FDA says it has issued four draft guidances and updated a final guidance relating to the Safety and Performance Based Pathway as part of its commitment to strengthening and modernizing the 510(k) program. The updated Safety and Performance Based Pathway guidance gives the agency’s current thinking on the
Devices
FDA has granted Active Implants a breakthrough device designation for the NUsurface Meniscus Implant. The device is made from medical grade polymer and because of its composite structure and design, it does not require fixation to bone or soft tissues, the company says. It mimics the function of the natural
Devices
FDA has cleared a Viseon 510(k) for its Voyant System to integrate minimally invasive surgical access with real-time high definition imaging. The device is intended to assist a physician’s intraoperative visualization, providing a precise and unimpeded view of the operative field, the company says. It offers a
Devices
FDA has issued a draft guidance, Safer Technologies Program for Medical Devices, introducing a new, voluntary program for certain medical devices and device-led combination products that are reasonably expected to significantly improve the safety of currently available treatments or diagnostics that target an underlying disease or condition associated with
Devices
Attorney Vernessa Pollard (McDermott Will & Emery) says that companies that secure digital health software precertification from FDA “may have increased post-market surveillance and data collection obligations, with a particular emphasis on real-world data.” Writing in an Of Digital Interest online blog post, she says that increased post-
Devices
FDA has cleared a Sofwave Medical 510(k) for its Sofwave system, indicated for use as an esthetic (XXX SPELLING XXX)treatment to improve facial lines and wrinkles. The company says the clearance was supported by a blinded study in 59 subjects. According to the investigators’ evaluation, 86% of the
Devices
FDA has granted Orchestra BioMed a breakthrough device designation for its Virtue Sirolimus-Eluting Balloon for treating below-the-knee peripheral artery disease. The device is designed to deliver sustained-release sirolimus during angioplasty without the need for coating or a permanent implant. “Angioplasty with plain balloons, which has been
Devices
FDA has cleared a Canon 510(k) for its Xephilio OCT-A1 Optical Coherence Tomography device for in-vivo imaging and measurement of the retina, retinal nerve fiber layer, and optic disc. In addition, it is intended to aid in the diagnosis and management of retinal diseases by a clinician.
Devices
An FDA advisory committee has recommended that FDA should develop standards for device companies to use when communicating any cybersecurity concern to patients. The agency’s Patient Engagement Advisory Committee met 9/10 to discuss communicating to patients about cybersecurity risks. “Preserving the benefit of these devices requires continuous vigilance