Devices
FDA has launched a new medical device Web page, “Use of Symbols in Labeling,” to assist the public in understanding the Use of Symbols in Labeling final rule that became effective 9/2016. The rule permits the use of symbols in device labeling without adjacent explanatory text (typically called “stand-
Devices
FDA has cleared a Faxitron 510(k) for the LOCalizer, a wireless radiofrequency identification (RFID) breast lesion localization system. The device uses a non-radioactive, proprietary tag as a marker to enable surgeons to remove the correct area of breast tissue during a procedure. The tag can be implanted up
Devices
The House Energy and Commerce Committee Subcommittee on Health will hold a 5/2 hearing on “Examining Improvements to the Regulation of Medical Technologies.” A subcommittee news release says that earlier this month bipartisan leaders of the full committee and the Senate HELP committee released a discussion draft of the
Devices
FDA has cleared a Bausch + Lomb 510(k) for Vitesse, a hypersonic device for vitreous removal. The device features a single-needle design and a continuously open-port system. It will exclusively operate on the company’s new Stellaris Elite Vision Enhancement System, the company’s next generation phacoemulsification cataract
Devices
FDA has cleared a Samsung 510(k) for the GC70 Digital Radiography (DR) system. The device “creates high-quality images with cutting-edge digital enhancements such as the S-Vue imaging engine, which provides high resolution images through adaptive filtering, the company says. It features S-Align to help provide
Devices
[Analysis by Jim Dickinson] “FDA is a slow-moving target that bleeds profusely when hit.” (Conventional wisdom from former FDA associate commissioner John Jennings, 1964-88.) FDA has never had a reputation for swift action. Even in the face of nine deaths and 714 sickenings, it took FDA a week
Devices
FDA has cleared a Diazyme Laboratories 510(k) for the Procalcitonin (PCT) assay. Procalcitonin, a propeptide synthesized in the C-cells of the thyroid, has been identified to be more clinically useful than currently used common clinical variables and laboratory tests in diagnosing sepsis, according to the company. “In healthy
Devices
Thermo Fisher Scientific and SpeeDx have signed an agreement to develop and submit for FDA clearance the ResistancePlus MG Test for detecting M. genitalium, a rapidly growing sexually transmitted infection that has developed significant resistance to first-line antibiotic treatments. Under the terms of the agreement, SpeeDx will submit the
Devices
FDA has classified as Class 1 a recent Medtronic recall of all unused units of the StrataMR adjustable valves and shunts due to an increase in product complaints, a rate estimated at 2.75% percent of total units distributed. The recall does not apply to the Strata II or Strata
Devices
FDA has posted a transcript of a 3/17 Ophthalmic Medical Devices Panel meeting that discussed and made recommendations regarding the potential risks of misuse of peroxide-based contact lens products. Most panelists agreed with redesigning the case and bottle to be functionally dependent. Another suggestion was creating a bigger
Devices
Attorneys Cameron Abbott and Giles Whittaker (K&L Gates) say FDA is threatening legal action against Abbott if the company doesn’t address safety and security issues in implanted cardiac devices sold by its recently acquired St. Jude Medical unit. Writing in an online blog post, the two say
Devices
FDA has cleared a Cardiac Insight 510(k) for its wearable electrocardiogram sensor, Cardea Solo. The device offers physicians immediate access to real-time reporting and analysis of heartbeat-to-heartbeat data. It is intended to be used to assist with diagnosing a variety of arrhythmias, including the most common,
Devices
FDA has cleared a Life Spine 510(k) for the Plateau-C Ti Cervical Spacer System. The device offers the company’s proprietary titanium surface technology, Osseo-Loc, which is a surface technology that helps create an environment for potential bone growth. It also offers “additional graft windows for increased
Devices
FDA has cleared an Edwards Lifesciences 510(k) for its HemoSphere advanced monitoring platform that is intended to provide clinicians with information on a patient’s hemodynamics. The device allows clinicians to “choose the clinical support screens that best suit their needs and monitor the pressures and blood flow of
Devices
FDA has cleared an electroCore 510(k) for the gammaCore vagus nerve stimulator for treating acute pain associated with episodic cluster headache in adult patients. The device transmits a mild electrical stimulation to the vagus nerve through the skin, resulting in reduced pain. The clearance is based on subgroup analyses
Drugs
The Coalition for Clinical Trial Awareness (CCTA) says Congress should include in the PDUFA reauthorization process “an effort to address a pressing public health challenge: lack of public awareness of the benefits of clinical trials leading to under-enrollment.” The request is in a 4/11 letter to leadership of
Drugs
The Biotechnology Innovation Organization (BIO) says that FDA’s Combination Product Policy Council should develop recommendations for implementation of provisions introduced in the 21st Century Cures Act, particularly recommendations to account for prior findings of safety and effectiveness or substantial equivalence for an approved constituent part. The organization also asks
Devices
FDA has classified as a Class 1 recall a Medtronic voluntary field action related to its HVAD System Controllers (serial numbers lower than CON300000) and DC Adapters (all serial numbers for product code 1435). FDA approved an updated controller on 4/7 and Medtronic began notifying U.S. clinicians about
Devices
[Analysis by Jim Dickinson] Picture this: Your company is in a bitter fight with another company to control a specialized market that each of you think isn’t big enough for both of you. What would it be worth to have FDA take your side in a marketplace brawl about
Devices
FDA has cleared an EnsoData 510(k) for EnsoSleep, a software-only medical device used under the supervision of clinicians to analyze physiological signals and automatically score sleep study results. EnsoSleep is intended for use for the diagnostic evaluation by physicians to assess sleep quality and as an aid in
Devices
FDA has cleared an Advanced Cooling Therapy 510(k) for use of its Esophageal Cooling Device (ECD) with the Altrix Precision Temperature Management System by Stryker. The ECD is designed to modulate and control patient temperature when clinically indicated through a single use, fully-enclosed triple lumen system that is
Devices
FDA has cleared an Additive Orthopedics 510(k) for its 3D printed Locking Lattice Plating System and its use to address stabilization and fusion of fractures, osteotomies, and arthrodesis of small bones. “These plates can be implanted either alone with locking or non-locking screws, or in conjunction with our