Devices
FDA has cleared a Centric Medical 510(k) for the Metatarsal Hemi Implant System, intended for treating patients with degenerative and post-traumatic arthritis in the metatarsal joint where there is good bone stock along with the following clinical conditions: hallux valgus or hallux rigidus, and an unstable or painful
Devices
Aeterna Zentaris says it is planning to seek FDA approval for Macrilen (macimorelin) for evaluating growth hormone deficiency in adults. A recent Phase 3 confirmatory study entitled Confirmatory validation of oral macimorelin as a growth hormone stimulation test for the diagnosis of adult growth hormone deficiency in comparison with the
Devices
Zimmer Biomet has begun a Class 1 recall of its Comprehensive Reverse Shoulder System Humeral Tray due to a higher than anticipated rate of fracturing that is design related. Such fracturing increases the risk of revision surgery, an FDA notice says. The company is asking that hospitals Immediately return all
Devices
FDA deputy director for personalized medicine Elizabeth Mansfield is leaving the agency next week to join cancer screening start-up Grail Inc. as its head of regulatory strategy. Mansfield had been at FDA for 10 years. Grail is a spin-off from Illumina, which makes most of the DNA sequencing
Devices
FDA says it has received multiple reports of two different types of adverse events associated with fluid-filled intragastric balloons used to treat obesity. An alert to healthcare providers says the first type of adverse event involves the balloon over-inflating with air or with more fluid in patients’ stomachs,
Devices
The Federal Trade Commission (FTC) has approved a final order settling charges that Valeant Pharmaceuticals International, the parent company of Bausch & Lomb, illegally acquired Paragon Holdings, a producer of polymer discs used in making rigid gas permeable contact lenses. The commission alleged that Valeant’s 2015 acquisition of Paragon
Drugs
The Medical Information Working Group, Pharmaceutical Research and Manufacturers of America, and Biotechnology Information Organization have petitioned FDA to indefinitely stay the agency’s 1/9 final rule relating to intended uses of drug, medical devices, and combination products and to reconsider the final rule. The petition says that agency
Devices
The Government Accountability Office (GAO) has completed a long-awaited report that confirms serious gaps in FDA’s medical device reporting process that failed to identify adverse events associated with power morcellators used in removing uterine fibroids. Power morcellators had been on the market for more than two decades before
Drugs
FDA has issued a guidance, Dear Healthcare Provider Letters: Improving Communication of Important Safety Information, to give industry recommendations on the content and format of Dear Healthcare Provider letters. Such letters, the document says, are intended to alert doctors and other healthcare providers about important new or updated information regarding
Devices
FDA has classified as Class 1 a CareFusion recall of its Alaris Syringe Pump due to an alarm error which may cause therapy interruption. The infusion pump is intended to deliver fluids, such as nutrients, blood and medications, into a patient’s body in controlled amounts. A recall notice says
Devices
A 6/27-6/30/16 FDA inspection at Implant Dental Technology, Guangdong, China, found Quality System Regulation violations in the firm’s manufacturing of porcelain-fused-to-metal restorations, porcelain restorations, partial dentures, and full dentures. A just-released 10/25/16 Warning Letter says that violations included: * failing
Devices
Rep. Ted Lieu (D-CA) has introduced H.R. 872, the Disclosure; and Encouragement of Verification, Innovation, Cleaning, and Efficiency Act of 2017 (DEVICE Act of 2017), “to enhance medical device communications and enhance device cleanliness.” The bill (text not yet available) would require medical device manufacturers to give advance
Devices
FDA has cleared a Bioness 510(k) for the L300 Go System, intended to provide ankle dorsiflexion in adult and pediatric individuals with foot drop and assist knee flexion or extension in those with muscle weakness related to upper motor neuron disease/injury (e.g., stroke, damage to pathways to
Drugs
Three Arent Fox attorneys say that a Trump administration executive order requiring agencies to identify two existing regulations to be repealed for every new regulation they propose could cause delays in FDA efforts to implement provisions of the 21st Century Cures Act. Writing in an online blog post, the attorneys
Drugs
FDA has delayed the effective date of a final rule that clarifies for drug and device manufacturers the agency’s interpretation and application of its existing definitions of “intended use.” The delay, according to an FDA notice, allows the Trump Administration to review and decide whether the rule should stay
Devices
A 5/9-5/12/16 FDA inspection at Neo Vision, Wonju-Si, Gangwon-Do, Korea, found violations of Quality System Regulations in the firm’s manufacturing of daily wear soft contact lenses. A just-released 9/14/16 Warning Letter says that violations shown on an FDA-483 included:
Devices
FDA has cleared an Elekta 510(k) for its Venezia applicator for gynecological brachytherapy in treating advanced-stage cervical cancer. Venezia received CE Mark approval in November 2016. “There is overwhelming clinical evidence that modern image-guided brachytherapy is an effective treatment modality for cervical cancer,” the company says. “Advanced
Devices
Medical device lobbying group AdvaMed continues to oppose adding unique device identifier (UDI) information to insurance claims forms. The opposition follows a recommendation by an advisory committee for Accredited Standards Committee X12 that a UDI device identifier should be a required field on a claims form when a “high-risk
Devices
FDA has permitted the marketing under the de novo process of Baebies Inc.’s Seeker System for screening four rare Lysosomal Storage Disorders (LSDs) in newborns. The device is designed to detect Mucopolysaccharidosis Type I (MPS I), Pompe, Gaucher and Fabry. It is the first newborn screening test permitted to
Devices
FDA has granted Abbott an emergency use authorization for its Abbott RealTime ZIKA test, a molecular test for detecting Zika virus in whole blood (when collected alongside a patient-matched serum or plasma sample). “This is the first molecular test made by a commercial manufacturer authorized to detect Zika in
Devices
The Justice Department says that three individuals have been arrested and charged in connection with a scheme to market the “QLaser” as a treatment for over 200 diseases and disorders, and for violating an earlier court order that was issued after the scheme was first uncovered. A department statement says
Drugs
A WilmerHale review of the False Claims Act (FCA) in 2016 predicts that FCA enforcement is likely to remain vigorous, particularly in cases involving contractors. The review notes that at his confirmation hearing, attorney general-designate Jeff Sessions said that “this government must improve its ability to protect the United