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
Devices
FDA has cleared an Entellus Medical 510(k) for the XprESS ENT Dilation System and its use in patients with persistent Eustachian tube dysfunction. The clearance is based on data from a trial in 60 patients who were randomized to either Eustachian tube dilation using XprESS or a control using
Devices
Attorney Kate Stewart (Mintz Levin) says the FBI recently issued guidance specifically applicable to medical and dental facilities about the cybersecurity risk of File Transfer Protocol (FTP) servers operating in “anonymous” mode. Writing in an online blog post, Stewart says FTPs are routinely used to transfer information between network hosts.
Devices
A 2/7-17 FDA inspection at Abbott’s St. Jude Medical manufacturing facility in Sylmar, CA, found Quality System Regulation violations in the firm’s manufacturing of the Fortify, Unity, and Assura (including Quadra) implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators and the Merlin@home monitor, according to
Devices
The Campaign for Mercury Free Dentistry is asking FDA to stop amalgam use in children under age 15, pregnant women, and breastfeeding mothers. The petition says that the European Union recently took that action effective 7/1/18. But “the U.S. government has done nothing to protect these vulnerable
Devices
FDA has cleared a Ventec Life Systems 510(k) for VOCSN, a portable life support device that combines five respiratory therapies — ventilation, oxygen, cough, suction, and nebulization. Ventec says the device is designed to work across the continuum of care, from the hospital to home, for pediatric patients weighing more
Devices
FDA has cleared a United Orthopedic 510(k) for its E-XPE polyethylene knee insert that is designed to provide patients with knee replacements with reduced risk of oxidation. The device is made of “highly cross-linked polyethylene blended with 0.1 percent (w/w) vitamin E to enhance wear
Devices
FDA says it is permitting marketing of the Philips IntelliSite Pathology Solution (PIPS), the first whole slide imaging system that allows for review and interpretation of digital surgical pathology slides prepared from biopsied tissue. An agency news release says it reviewed the data for the PIPS through the de novo
Devices
FDA has cleared an Alere 510(k) for the Alere Reader, a diagnostic analyzer that can be used in both point-of-care and laboratory settings. The company says the device will initially be available for use with the BinaxNOW Influenza A & B Card 2, a rapid antigen influenza
Devices
FDA has cleared a Becton Dickinson 510(k) for a flow cytometer system with a leucocount reagent assay used in residual white blood cell enumeration. The device provides blood banks and clinical laboratories with an “easy-to-use cell analysis solution to help determine and quantify the presence of residual
Devices
FDA has issued Nanobiosym Diagnostics an emergency use authorization for the Gene-RADAR Zika Virus Test. The device is authorized for the qualitative detection of RNA from Zika virus in human serum from individuals meeting Centers for Disease Control and Prevention Zika virus clinical or epidemiological criteria. “Currently, Zika virus
Devices
FDA and other regulatory bodies participating under the International Medical Device Regulators Forum (IMDRF) have released a final guidance document on “IMDRF Terminologies for Categorized Adverse Event Reporting (AER): Terms, Terminology Structure and Codes.” Widespread use of a single adverse event terminology and coding system could improve signal detection by
Devices
FDA has cleared a Verax 510(k) to expand the indications for the Verax Platelet PGD Test to include single units of leukoreduced or non-leukoreduced whole blood derived (WBD) platelets in plasma. The test previously was cleared for testing post storage pools of up to six leukoreduced or non-
Devices
Medtronic has recalled 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 NSC products, according to a recall notice. The
Devices
CDRH officials have provided their viewpoint on differing clinical trial considerations in producing data to justify marketing approval or clearance. Writing in a 6/6 New England Journal of Medicine review article, CDRH director Jeff Shuren and Office of Device Evaluation clinical trials director Owen Faris acknowledge the shift to
Devices
FDA has cleared a Qiagen 510(k) for the ipsogen JAK2 RGQ PCR Kit for detecting mutations affecting the Janus Tyrosine Kinase 2 (JAK2) gene. This is the first FDA-authorized test intended to help physicians in evaluating patients for suspected Polycythemia Vera (PV), according to the agency. Diagnoses of
Devices
The latest annual Emergo study of 510(k) submissions to FDA looked at some 15,000 applications cleared by the agency between 2012 and 2016 and determined that U.S. manufacturers are submitting applications less frequently than in previous years, while submissions from foreign countries have increased. The firm’s
Devices
FDA says that 23andMe can market its Personal Genome Service Genetic Health Risk tests for 10 diseases or conditions. An agency statement says they are the first direct-to-consumer tests authorized by FDA that provide information on an individual’s genetic predisposition to certain medical diseases or conditions, which
Devices
New York attorney general Eric Schneiderman is using state trade laws to extract concessions and monetary penalties from mHealth app developers, according to attorneys Kristi Kung and Sean Cuddihy (Sheppard Mullin). Writing in an online blog post, Kung and Cuddihy say Schneiderman has taken action against Israel-based Matis for
Drugs
A Foley online white paper, “Guidebook: Cybersecurity in the Pharma, Biotech, and Medical Device Industries,” is intended to help industry members focus on cybersecurity and intellectual property asset issues in an accessible and practical way. The guidebook says that for life science and medical device companies it is “mission critical
Devices
Following reports of a new outbreak of antibiotic-resistant infections associated with duodenoscopes, Sen. Patty Murray (D-WA) is asking Olympus Corp. officials to confirm that its “repaired” closed-channel duodenoscopes are safe for use. Murray says the scopes in question were reportedly rebuilt under an agreement between Olympus and