Devices
FDA has cleared Gelesis’ Plenity (Gelesis100) as an aid in weight management in adults with a body mass index of 25 to 40 kg/m when used in conjunction with diet and exercise. The prescription device is administered in the form of capsules taken with water before lunch and dinner.
Devices
As a follow-up to a 12/2018 safety communication on preliminary findings from studies on marketed duodenoscopes, a new update says the findings now show that up to 5.4% of all properly collected samples tested positive for “high concern” organisms, which is significantly higher than the earlier 3%
Devices
FDA says it is helping to mitigate a temporary shortage of pediatric breathing tubes due to the recent closure of Sterigenics’s Willowbrook, IL sterilization facility. Last month, the agency was notified by health care providers, patients, and Smiths Medical that the facility’s closure caused a potential device shortage
Devices
The Protect Medical Innovation Act of 2019 (H.R. 2207), which is sponsored by both Democrats and Republicans, would permanently repeal the medical device excise tax. AdvaMed CEO Scott Whitaker praised the legislation, saying the medical technology industry “is facing a $20 billion tax increase at year-end, when the
Devices
FDA has cleared an Elucent Medical 510(k) for the EnVisio Surgical Navigation System. “Placed at the time of the breast biopsy, Elucent Medical’s permanently implantable wireless SmartClip Soft Tissue Marker provides an alternative to painful and costly localization procedures, in which the standard approach is to place a
Devices
FDA has cleared an Ortho Clinical Diagnostics 510(k) for the Vitros XT MicroSlides, featuring new multi-test technology that allows labs to run two tests simultaneously on one slide. The product pairs tests that physicians typically order together, including triglycerides and cholesterol, urea and creatinine, and glucose and calcium.
Devices
FDA is extending the comment period by 30 days for its Modernizing the Food and Drug Administration's 510(k) Program: Request for Comments regarding FDA’s proposal to consider making public on its Web site cleared devices that demonstrated substantial equivalence to older predicate devices. Late last year,
Devices
FDA has issued its finalized list of medical device accessories suitable for Class 1. A Federal Register notice says the agency has determined that general controls alone are sufficient to provide reasonable assurance of safety and effectiveness for the accessories. It says the determination was made based on the risks
Devices
FDA has cleared a CivCo Radiotherapy 510(k) for its GrayDuck Stents, which are intended to provide custom oral positioning with repeatable tongue deviation during radiotherapy. The device is designed to improve patient treatment and outcomes by sparing the tongue, taste buds and salivary glands from unnecessary doses, the company
Devices
FDA has cleared an Elucent Medical 510(k) for the EnVisio Surgical Navigation System. “Placed at the time of the breast biopsy, Elucent Medical’s permanently implantable wireless SmartClip Soft Tissue Marker provides an alternative to painful and costly localization procedures, in which the standard approach is to place a
Devices
FDA has cleared a Getinge 510(k) for a new software version for the Servo-u and Servo-n mechanical ventilator platform. The software release includes the addition of Servo Compass and High Flow therapy as well as additional advancements for ventilation therapy support, according to the company. The software
Devices
FDA has cleared an Avinger 510(k) for its Pantheris SV (Small Vessel) image-guided atherectomy system. The device, which is designed with a lower profile and longer length than its original Pantheris, is indicated for diagnosing and treating peripheral artery disease in small vessels (2 to 4 millimeters in
Devices
FDA has denied a Helius Medical Technologies de novo marketing request for its Portable Neuromodulation Stimulator (PoNS) device for treating patients with chronic balance deficit due to traumatic brain injury. In its rejection letter, the agency said there was not sufficient information to discern the relative independent contributions of the
Devices
FDA says it is concerned that products that have not been cleared or approved by the agency are being marketed to individuals, including parents and caregivers, athletic coaches, and healthcare providers, for the assessment, diagnosis, or management of a head injury, including concussion. The agency issued a safety communication “to
Devices
FDA has cleared an Innoblative Designs 510(k) for Sira RFA Electrosurgical Device, a novel radiofrequency ablation applicator that supplies energy for use in electrosurgery, specifically for intraoperative coagulation and ablation of soft tissue. The device was designed to ablate large surface areas, the company says, adding that the “large
Devices
Myriad Genetics has submitted the first module of a planned PMA for the myChoice HRD CDx test, a companion diagnostic for identifying patients with ovarian, fallopian or primary peritoneal cancer who have received three or more lines of therapy and whose tumors harbor a BRCA mutation or are BRCA wild
Devices
FDA has cleared an Aggredyne 510(k) for the AggreGuide A 100 ADP Assay testing cartridge, an in vitro diagnostic device used to measure the effect of various antiplatelet medications that target the platelet P2Y12 receptor. Clearance is based on clinical data using FDA-approved combinations of dual anti-platelet
Devices
FDA has issued a safety alert about online marketers selling pre-owned test strips or test strips not authorized for sale in the U.S. to consumers. The agency says the test strips may not be safe to use because they might not have been stored properly or their expiration
Devices
FDA has cleared a Spry Health 510(k) to market the Loop System, a clinical-grade wearable that measures pulse oximetry, respiration rate and heart rate. The device is intended to allow clinicians to remotely monitor their patients with chronic diseases, such as chronic obstructive pulmonary disease, according to the
Devices
FDA has cleared an Avanos Medical 510(k) for its improved On-Q with Bolus pump for reducing postoperative opioid use to achieve pain management. The device is intended to provide “customized control for patients recovering from post-surgical pain by delivering continuous, non-opioid medication to the surgical site
Devices
FDA has approved a TherOx PMA for its SuperSaturated Oxygen (SSO2) Therapy that is intended to provide interventional cardiologists with a treatment beyond percutaneous coronary intervention (PCI) to significantly reduce muscle damage in heart attack patients. The therapy delivers hyperbaric levels of oxygen directly to ischemic heart muscle immediately after
Devices
FDA has issued a Warning Letter to Inova Genomics Laboratory for illegally marketing certain genetic tests that have not been reviewed by FDA for safety and effectiveness. An agency media statement says the tests claim to predict patients’ responses to specific medications based on genetic variants. “Selecting or changing drug