Devices
FDA has approved a Vascular Dynamics IDE application to start a pivotal CALM 2 (Controlling and Lowering Blood Pressure with MobiusHD) trial of its Mobius system for treating resistant hypertension. The trial will evaluate patients from multiple U.S. sites whose hypertension remains uncontrolled despite three or more antihypertensive pharmacologic
Devices
FDA has cleared a BioStable Science & Engineering 510(k) for the HAART 200 Aortic Annuloplasty Device, an annuloplasty device designed specifically for bicuspid aortic valve repair. The device is designed to facilitate valve repair in patients with aortic valve insufficiency. It is intended to reduce annular diameter based upon
Devices
Medtronic says it will conduct a randomized clinical to evaluate one-month dual antiplatelet therapy (DAPT) — the combination of aspirin and an anti-clotting medication — in patients implanted with the Resolute Onyx Drug-Eluting Stent (DES) during percutaneous coronary intervention. The study is intended to help provide DAPT guidelines for
Devices
FDA has cleared a Renovis Surgical Technologies 510(k) to market posterior lumbar Tesera porous titanium interbody fusion systems. The device line features implants for direct posterior or transforaminal approaches in both straight and curved options, according to the company. Multiple heights, widths and lengths are available to better fit
Devices
CDRH has released frequently asked questions (FAQs) about the new medical device pre-certification pilot program. The document covers 13 questions about eligibility for the program and how it will operate.
Devices
FDA has issued a safety alert update based on receiving five reports of unanticipated deaths since 2016 in patients with liquid-filled intragastric balloon systems used to treat obesity. “Four reports involve the Orbera Intragastric Balloon System, manufactured by Apollo Endo Surgery, and one report involves the ReShape Integrated Dual
Devices
CDRH has released materials from its 8/1 webinar on the digital health precertification pilot program. There is an audio file of the presentation, a transcript of the presentation, and the slides used during the program. The software precertification pilot program is described as a voluntary pilot program that will
Devices
FDA has released a final guidance, Qualification of Medical Device Development Tools, formalizing the medical device development tools (MDDT) program that started with a 2013 pilot. CDRH says it believes the policy will facilitate the development and timely evaluation of medical devices by providing a more efficient and predictable means
Devices
FDA has cleared a Stimwave 510(k) for the StimQ Peripheral Nerve Stimulator (PNS) System, a wireless, micro-technology neuromodulation device for treating chronic peripheral nerve pain. The clearance enables the pain sufferer to have frequent and necessary MRI scans of any part of their body without removing the implant,
Devices
Siemens says it is preparing updates for four medical molecular imaging products that run on Windows 7 as a result of identifying vulnerabilities in the products. A TechXplore online post says the Department of Homeland Security reported that the company had identified the vulnerabilities. The department said the vulnerabilities could
Devices
FDA has cleared a Mauna Kea Technologies 510(k) for its CelioFlex UHD Confocal Miniprobes for use with the company’s Cellvizio laser endomicroscopy platform in robotic-assisted surgery procedures. The Miniprobes are intended to provide visualization of body cavities, organs, and canals during endoscopic and laparoscopic surgical procedures. The
Devices
FDA has cleared a GE Healthcare 510(k) for the Signa Premier, a new wide bore 3.0T magnetic resonance imaging system. The device is the result of a four-year collaboration with the National Football League and research institutions around the world working to design new imaging tools, particularly
Devices
FDA has cleared a Standard Bariatrics 510(k) for the Standard Clamp, a disposable laparoscopic surgical clamp that is intended to assist surgeons performing laparoscopic sleeve gastrectomy, said to be the most common and effective weight loss surgery. The company says that more than 60% of patients seeking a surgical
Devices
CDRH and the Radiological Society of North America 3D Printing Special Interest Group will hold a joint meeting 8/13 on the clinical use of 3D printed patient-specific anatomic models. The meeting is intended to focus on clinically used models to identify current best practices, levels of benefit vs.
Devices
FDA has approved a Medtronic PMA for its new Avalus pericardial aortic surgical valve for treating aortic valve disease. The device “leverages proven surgical bioprosthetic valve concepts with added features designed to enhance clinical performance, helping to address the contemporary needs of cardiac surgeons, as well as patients who are
Devices
FDA has announced an ambitious series of actions as part of its Digital Health Innovation Action Plan to be completed between now and the first quarter of 2018. Attorney Suzan Onel (Kleinfeld, Kaplan and Becker) writes in an analysis that the agency says it is “redesigning” and “reimagining” its approach
Devices
FDA has cleared a Xavant Technology 510(k) for the Stimpod NMS460, a hybrid-pulsed radio frequency waveform neuromodulation device for relieving and managing chronic intractable pain, as well as an adjunctive treatment in managing post-surgical pain, post-traumatic acute pain problems, and an adjunct for pain control due
Devices
Sen. Richard Blumenthal (D-CT) has introduced a bill (S 1656) to amend the federal Food, Drug, and Cosmetic Act to provide cybersecurity protections for medical devices. The measure would create a cyber “report card” for medical devices and require manufacturers to obtain consent from healthcare providers before remotely accessing
FDA Policy/General
[Analysis by Jim Dickinson] “It seems every two or three years we have another controversy in women’s health,” a 7/30 Washington Post Magazine article quotes Northwestern University health policy researcher Steven Xu as saying, about the ongoing controversy over Bayer’s permanent contraceptive device Essure. Xu co-authored
Devices
FDA has cleared an Immunalysis 510(k) for the Sefria Fentanyl Urine Enzyme Immunoassay for the qualitative detection of fentanyl in urine. The device is the first analyte utilizing Immunalysis’ proprietary Sefria technology. Previously, fentanyl immunoassay tests were only available for forensic testing, according to the company. With the clearance,
Devices
FDA has approved a Bracco Diagnostics PMA for Aribar Nectar (barium sulfate) oral suspension for use in modified barium swallow (MBS) examinations to evaluate the oral and pharyngeal function and morphology in adult and pediatric patients with known or suspected swallowing disorders. The product is designed to provide “adequate visibility
Devices
FDA has approved a Quantel Medical PMA for the Easyret fully integrated 577nm yellow photocoagulator, indicated for use to treat certain forms of macular edema and peripheral retinal pathologies. The device is based on Quantel’s proprietary ELBA fiber laser technology, which “delivers pure 577nm yellow wavelength in a uniform