Devices
The Campaign for Mercury Free Dentistry has petitioned FDA to amend its mercury amalgam rule to require patient labeling for dental amalgam. The petition urges the agency to require manufacturers to distribute patient labeling containing information on (1) amalgam’s mercury content; (2) amalgam’s risks to children and fetuses;
Devices
Alcon has recalled its LenSx Laser System, indicated for use in patients undergoing cataract surgery and refractive surgery, after receiving reports concerning incomplete corneal flap creation. An FDA recall notice says the device errors are related to a “software design (manufacturing process).” The company has sent users a recall notification
Devices
Roche has filed a 510 (k) for a fully automated assay for detecting antibodies to Treponema pallidium for use on all Roche immunoassay systems for low-, mid- and high-volume testing systems, including the cobas e 411, cobas e 601, cobas e 602 and Modular Analytics E170 analyzers. The assay
Drugs
Deputy attorney general Sally Yates, who drafted the Individual Accountability Policy that has become known as the “Yates Memo,” says that implementation of the policy has already had the desired effect of changing corporate behavior. Speaking to the 5/10 New York City Bar Association White Collar Crime conference, Yates
Devices
Zimmer Biomet, Stryker, and Johnson & Johnson all say they agree with comments submitted by AdvaMed on an FDA draft guidance on characterization of ultrahigh molecular weight polyethylene (UHMWPE) used in orthopedic devices. Stryker says that as in the AdvaMed comments, it also recommends that the agency finalize the guidance
Devices
FDA has cleared a Millennium Dental Technologies 510(k) for periodontal regeneration (new cementum, new periodontal ligament, and new alveolar bone) on a previously diseased root surface using the company’s LANAP protocol. Using a PerioLase MVP-7 laser, doctors can “stimulate and activate oral stem cells, in particular fibroblasts,
Devices
Opposition to FDA’s medical device unique device identifier (UDI) program appears to be waning at the Center for Medicare and Medicaid Services, according to recent remarks made by CMS acting administrator Andy Slavitt. CMS had opposed adding the UDI to claims forms due to technological challenges associated with the
Devices
FDA has cleared a Bone Index 510(k) for the Bindex point-of-care instrument, which is intended to help in osteoporosis diagnosis. The device measures the cortical bone thickness of the tibia and its algorithm calculates a density index, a parameter which estimates bone mineral density at the hip
Devices
FDA has cleared a First Ray 510(k) for its CortiClamp System for small bone fixation. The device uses a second screw head that is attached to the distal end of the screw, providing screw heads on both ends of the screw shaft that create a bi-cortical clamping force,
Devices
Medtronic has recalled its battery pack used with the Capnostream 20 and Capnostream 20p Patient Monitors due to the potential for thermal runaway that presents a fire risk to the monitor. The battery pack powers the monitor when AC power is not available or when monitoring is required during intra-
Devices
FDA has finalized a guidance on “Postmarket Surveillance Under Section 522 of the Federal Food, Drug and Cosmetic Act” that provides recommendations on the format, content, and review of postmarket surveillance plan submissions. Section 522 gives FDA the authority to order postmarket surveillance for any Class 2 or 3 device
Devices
FDA has approved a NeoChord, Inc. IDE to begin a clinical study of its artificial chordae delivery system, DS1000, a trans-apical beating heart procedure for replacing ruptured or elongated chordae in patients with degenerative mitral valve regurgitation. The company says it is the first U.S. study of its
Devices
Reason TV, an online content provider using YouTube, has created a 10-minute documentary film “celebrating the courage” of Vascular Solutions and its CEO Howard Root in mounting a successful $25 million defense against government criminal charges of illegal off-label promotion of the company’s Vari-Lase Short Kit.
Devices
AdvaMed senior executive vice president for technology and regulatory affairs Janet Trunzo says the Advancing Breakthrough Devices for Patients Act of 2016 “does nothing to lessen FDA’s current rigorous approval standards for breakthrough medical devices and diagnostics, but instead will improve access to potentially life-saving and life-enhancing
Devices
AdvaMed says that given the many substantive requirements in a new FDA draft guidance on characterization of ultrahigh molecular weight polyethylene used in orthopedic devices, as well as in the existing draft guidance that the new one replaces, it will be important for the agency to finalize the latest draft
Devices
FDA has issued a draft guidance on “Infectious Disease Next Generation Sequencing Based Diagnostic Devices:Microbial Identification and Detection of Antimicrobial Resistance and Virulence Markers,” which provides recommendations for studies to establish the analytical and clinical performance characteristics of such devices. “Each unique specimen type may require a different nucleic
Devices
FDA has cleared an EndoGastric Solutions 510(k) for the EsophyX Z device for treating gastroesophageal reflux disease using transoral incisionless fundoplication. “Designed for compatibility with the company’s existing 7.5 mm SerosaFuse Implantable Fastener cartridges, the device allows physicians to reconstruct the gastroesophageal valve and then secure tissue
Drugs
A Harvard School of Public Health poll finds that a majority of Americans don’t favor some key provisions of the 21st Century Cures Act and its companion Senate legislation. The poll also found that few people think FDA does a good job of regulating prescription drugs and medical devices.
Devices
NDA Partners has formally added medical device expert consulting to its service offerings for product development and regulation. The device team offers a “wide range of services to assist in all phases of the regulatory processes involved with medical devices and diagnostics, including medical equipment, implants, in vitro and imaging
Devices
FDA has granted Lungpacer Medical an Expedited Access Pathway (EAP) designation for the Lungpacer Diaphragm Pacing System for treating patients who have been unable to wean from mechanical ventilation. Traditional mechanical ventilation can be harmful to a patient because it interrupts the normal activation of the diaphragm muscle, which then
Devices
FDA has approved an Integra LifeSciences PMA for its Omnigraft Dermal Regeneration Matrix, indicated for use in treating partial and full-thickness neuropathic diabetic foot ulcers that are greater than six weeks in duration, with no capsule, tendon or bone exposed, when used in conjunction with standard diabetic ulcer care.
Devices
The Association of Clinical Research Organizations (ACRO) says that a survey indicates a coming rapid increase in use of wearable technology and an upsurge in social media for patient recruitment. “ACRO members are at the forefront of developing and implementing new clinical trial technologies to enhance efficiency and improve the