Devices
FDA has given 510(k) clearance to Xcision Medical Systems’ GammaPod stereotactic radiotherapy system intended to treat cancer in breast tissue. An agency news release notes that some 60% of all cancer patients are treated with some form of radiation therapy. The GammaPod system is intended for use in the
Devices
FDA is permitting marketing of Sanuwave’s Dermapace System, described by the agency as the first shock wave device intended to treat diabetic foot ulcers. An agency news release says the system is intended to be used to treat chronic, full-thickness diabetic foot ulcers with wound areas measuring no
Devices
CDRH and CBER are proposing a Voluntary Malfunction Summary Reporting Program for manufacturer reporting of certain device malfunction medical device reports (MDRs) in summary form. A Federal Register notice says the proposed program reflects goals for streamlining malfunction reporting outlined in the MDUFA 4 commitment letter. The goals include permitting
Devices
Physio-Control has recalled its defibrillation electrodes due to incorrect placement instructions for infants that were depicted on artwork. The Class 1 recall affects defibrillation electrodes used on the Lifepak Express AED, Lifepak CR Plus AED, Lifepak 1000 defibrillator, or Lifepak 500 Biphasic AED with a pink connector. Defibrillation electrodes
Devices
Sterilmed has begun a Class 1 recall of its Reprocessed Agilis Steerable Introducer Sheath due to an improper seal of the sheath hub. “Improper seals can allow blood to leak through the hub, cause the cap to fall off during the procedure, or can create a difference in pressure that
Devices
Medtronic has reached a $12 million settlement with five states to resolve allegations that it unlawfully promoted to doctors its Infuse bone graft device used in spinal fusion procedures. Oregon attorney general Ellen Rosenblum announced the settlement and said her state would receive $2.4 million. The other states participating
Devices
FDA has published a draft guidance, The Least Burdensome Provision: Concept and Principles, to describe the guiding principles and recommended approach for FDA staff and industry to facilitate consistent application of least burdensome principles, as required by Congress in the FDA Modernization Act of 1997 for medical device premarket evaluation.
Devices
An updated FDA assessment of the use of laparoscopic power morcellators (LPMs) to treat uterine fibroids says the agency continues to caution against their use in the majority of women undergoing myomectomy or hysterectomy to treat fibroids. “While minimally invasive surgery conveys several advantages over open surgery for women with
Devices
FDA has cleared a Chemence Medical 510(k) to market and sell Exofin Fusion, a new skin closure system for medium to large wounds. The device combines a self-adhering flexible mesh strip, mesh anchors and a 2-octyl cyanoacrylate topical adhesive to close and seal large incisions while forming
Devices
FDA has cleared a Gel-e Inc. 510(k) for its adhesive bandage for prescription and over-the-counter use in managing moderately to heavily exuding chronic wounds and acute wounds. Under medical supervision, the bandage may be used for managing pressure sores, diabetic ulcers, leg ulcers, donor sites and
Devices
FDA has approved a Boston Scientific PMA for the Vercise Deep Brain Stimulation System and its use for treating symptoms of Parkinson’s disease. The device works by stimulating a targeted region of the brain through implanted leads that are powered by an implantable pulse generator. Approval was based on
Devices
Three CDRH staffers working in the Early Feasibility Studies (EFS) program that the number of investigational device exemptions (IDE) submitted for EFS has more than doubled from 26 submissions in the first year after the EFS guidance was finalized to 57 submitted in FY 2017. Writing in an FDA Voice
Devices
FDA has expanded the approved use of GlaxoSmithKline’s Nucala (mepolizumab) to treat adult patients with eosinophilic granulomatosis with polyangiitis (EGPA), a rare autoimmune disease that causes vasculitis. Formerly, EGPA was known as Churg-Strauss syndrome, a condition characterized by asthma, high levels of eosinophils (a type of white blood
Devices
CDRH says it is actively working to increase appropriate use and improve the impact of PROs (patient-reported outcomes) as evidence in regulatory decisions and beyond. The Center makes the commitment in a strategic priority document — Value and Use of Patient-Reported Outcomes (PROs) in Assessing Effects of Medical Devices.
Devices
AdvaMed says FDA’s voluntary medical device manufacturing and product quality program (appraisal program) reflects “the agency’s use of innovative strategies to collaborate with stakeholders to improve medical device design and manufacturing quality and, by extension, public health outcomes…. AdvaMed supports the appraisal program and hopes it will succeed
Devices
Early next year, FDA says it will publish a draft guidance outlining a voluntary, alternative pathway for demonstrating substantial equivalence to meet 510(k) criteria for certain devices. “This pathway will allow more flexibility to use more modern criteria as the reference standard, and permit comparisons to standards that more
Devices
FDA has approved an Intersect ENT PMA for the Sinuva (mometasone furoate) Sinus Implant, a new targeted approach to treating recurrent nasal polyp disease in patients who have had previous ethmoid sinus surgery. Inserted during a routine physician office visit, Sinuva expands into the sinus cavity and delivers an anti-
Devices
FDA has cleared a Genea Biomedx 510(k) for its benchtop incubator Geri. The continuous embryo monitoring benchtop incubator is designed to offer undisturbed incubation for embryos during in vitro fertilization treatment. Genea Biomedx says the device is used with the company’s Geri culture medium to provide a continuous
Devices
FDA commissioner Scott Gottlieb says the agency has issued two draft and one final guidance to “continue to expand our efforts to encourage innovation in the ever-changing field of digital health. Our aim is to provide more clarity on and innovative changes to our risk-based approach to digital
Devices
Bayer vice president Steven Immergut 12/7 disputed a complaint by Rep. Rosa DeLauro (D-CT) as reported by FDA Webview 12/4 that the company is under-performing on a commitment it made to FDA to study the post-marketing experience with its controversial permanent birth-control device, Essure.
Devices
FDA has cleared a Camber Spine 510(k) for the SPIRA-C Open Matrix Cervical Interbody device, an interbody fusion implant. The 3D-printed titanium implant is designed to enhance fusion, according to the company. It uses the company’s SPIRA Arch Technology that creates an environment for cell proliferation
Devices
A CDRH 11/30 Webinar reviewed key changes to the recently finalized guidance Unique Device Identification: Direct Marking of Devices. UDI (unique device identifier) program regulatory policy analyst Christina Savasaar said the agency received 17 comments on its draft guidance from external stakeholders and published the final guidance 11/17.