Devices
FDA says it continues to evaluate information from several sources, including endovascular graft system manufacturers, about the risks associated with Type III endoleaks with various aortic endovascular graft systems indicated for treating abdominal aortic aneurysms and aorto-iliac aneurysms. In 9/2017, an FDA letter to health care providers alerted
Devices
FDA says it is seeking public input and comment on an updated version of its software precertification program working model. An update notice (contains links to the updated working model, the comment docket, and other resources) says the new version outlines these pre-certification program key components: Excellence Appraisal and
Devices
FDA has cleared a B. Braun Medical 510(k) for its wireless second generation software for its Perfusor Space Syringe Pump. This is the first syringe pump with air and road transport in its cleared indications for use, according to the company. It is also integrated with DoseTrac, DoseGuard, and
Devices
FDA has cleared an Arcuro Medical 510(k) for its SuperBall meniscus repair system. The all-suture device is intended to preserve knee functionality and features “no knot in the joint space,” according to the company. Arcuro says it expects to convert a significant portion of the meniscus removal procedures
Devices
FDA has approved Medtronic’s 200mm and 250mm lengths of its In.Pact Admiral Drug-Coated Balloon to treat long superficial femoral artery lesions in patients with peripheral artery disease. Approval was based on clinical data from the complex lesion imaging cohorts of the company’s In.PACT Global Study,
Devices
FDA has posted a guidance on “Logical Observation Identifiers Names and Codes for In Vitro Diagnostic (IVD) Tests.” FDA notes that with the use of electronic health records (EHR), there has been a greater demand to standardize the way that IVDs are coded. The document discusses how laboratories commonly associate
Devices
Members of the FDA Circulatory System Devices Advisory Committee voted 11-4 on 6/12 to recommend that the agency give premarket approval to Cordis’ Incraft stent-graft device for abdominal aortic aneurysms. FierceBiotech reports that the device is deployed through the artery and opened to seal and relieve pressure
Devices
FDA has issued a draft guidance, Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings—Labeling Considerations, with recommendations for information to be included in the device labeling submitted in PMAs or 510(k)s for Class 3 and 2 devices containing lubricious coatings used in the vasculature to enhance
Devices
FDA has issued a draft guidance, Coronary, Peripheral, and Neurovascular Guidewires—Performance Testing and Recommended Labeling, to assist industry in designing and executing appropriate performance testing to support a premarket notification. It also provides recommendations for content and labeling to include in 510(k) submissions. When final, the document will
Devices
FDA has cleared a LivaNova 510(k) for its MEMO 4D semi-rigid mitral annuloplasty ring. The next-generation addition to the MEMO line offers a broader range of ring sizes from 24 to 42mm allowing an additional patient population with mitral regurgitation (MR) to be treated, according to the
Devices
FDA has cleared an Optovue 510(k) for its Avanti Widefield Optical Coherence Tomography system for non-contact, quantitative measurements of the epithelial and stromal layers of the cornea (epithelial thickness mapping or ETM). The expanded clearance adds a nine-millimeter ETM scan to the previously available six-millimeter map,
Devices
FDA has approved a Wright Medical Group PMA for Augment Bone Graft for use in hindfoot and ankle fusion. The injectable product combines recombinant human platelet-derived growth factor and a blend of Type 1 collagen and beta tri-calcium phosphate, which is designed as an alternative to autograft. The
Devices
FDA has cleared a Gold Standard Diagnostics 510(k) for its Borrelia burgdorferi IgG/IgM ELISA assay. The test is intended as an initial screening assay in the CDC-recommended two-step testing for evidence of antibodies against the Lyme disease bacteria. Both steps can be performed using the same
Devices
FDA has told Congress that, as mandated by the 21st Century Cures Act, it has implemented mandatory training on the least burdensome requirements for medical device review staff and supervisors, conducted an audit of such training, and sought input from the medical device industry on companies’ experience with respect to
Devices
FDA has issued a draft guidance on its “Humanitarian Device Exemption (HDE) Program” that clarifies the current review practices for the regulatory pathway. The document addresses commonly asked questions about HDEs, including FDA actions on HDE applications, post-approval requirements, and special considerations for devices marketed under the program. Additionally,
Devices
FDA has issued a safety update on LivaNova’s Stӧckert 3T Heater-Cooler System (3T) to help prevent the spread of infection related to the use of the devices. This update amplifies livanova’s 4/20 medical device correction announcing the availability of “deep cleaning” services of certain 3Ts in
Drugs
As part of its response to efforts to rein in prescription drug costs, FDA has issued two updated final guidances to provide greater clarity about its thinking and recommendations for certain medical product communications. The first guidance, Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities—Questions
Devices
FDA has cleared an Optovue 510(k) for its AngioAnalytics, an optical coherence tomography angiography (OCTA) blood vessel measurement technology to help clinicians manage diseases that cause progressive blindness. The company also received 510(k) clearance for its three-dimensional projection artifact removal (3D PAR) software, which is designed to
Devices
FDA has cleared a Centinel Spine 510(k) to market its FLX Platform of integrated interbody and non-integrated interbody fusion devices. The 3D-printed, all-titanium devices feature a combination of solid and porous radiolucent sections designed to reduce mechanical stiffness and improve visibility, compared to solid titanium implants,
Devices
FDA has cleared an Edap TMS 510(k) for its Focal One device for ablating prostate tissue. The high-intensity focused ultrasound device is the “first medical apparatus designed specifically for focal treatment of the prostate,” the company says. “Focal One fuses MR and 3D biopsy data with real-time
Devices
TransEnterix has submitted a 510(k) for additional Senhance System instruments, including 3mm diameter instruments. TransEnterix says it is the first company to seek FDA clearance for robotically-driven 3 mm instruments for abdominal surgery in the U.S. Their clearance would allow the Senhance to be used for “scarless”
Devices
Draeger Medical Systems begun a Class 1 recall of its Draeger Jaundice Meter due to a device design flaw. Users have misinterpreted the display for out-of-range measurement indicated by a blinking “0” to mean a zero measurement, a recall notice says. The device is intended for use in