Devices
FDA has published a guidance, Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation, to help facilitate the systematic collection of how patients feel, function, and survive as valid scientific evidence to support the regulatory and healthcare decision-making process. The document
Devices
FDA has announced a 4/5-6 virtual public workshop entitled “Study Design Considerations for Transbronchoscopic Thermal Ablation (TTA) Devices for the Treatment of Oligometastases to the Lung (OML).” The workshop is intended to provide a forum for stakeholders to share information so FDA can develop appropriate regulatory review approaches
Devices
FDA has approved a Medtronic PMA for its Intellis rechargeable neurostimulator and Vanta recharge-free neurostimulator for treating chronic pain associated with diabetic peripheral neuropathy (DPN). DPN occurs when high blood sugar damages nerves in the body, most often in the legs and feet, leading to numbness and burning or
Devices
FDA has cleared a Biotricity 510(k) for its Biotres Cardiac Monitoring Device, a three-lead holter device for electrocardiogram and arrhythmia monitoring that is intended for lower risk patients. The device, which the company says is designed to address current limitations of existing holter monitors technologies, features three-channel
Devices
FDA has granted Cook Medical a breakthrough device designation for its new drug-eluting stent for below the knee (BTK) use. The new stent is designed to treat patients suffering from chronic limb-threatening ischemia. “This new product leverages our deep understanding of stent design and drug elution for lower
Devices
Medtronic has recalled its HawkOne Directional Atherectomy System due to the risk of the guidewire within the catheter moving downward or prolapsing when force is applied during use. The device comprises a catheter and a cutter driver, and is used during procedures intended to remove blockage from peripheral arteries and
Devices
The FDA proposed rule on establishing over-the-counter (OTC) hearing aids to implement provisions of the FDA Reauthorization Act of 2017 has drawn praise and recommendations for change from several stakeholders. The Federal Trade Commission commented that it supports the proposed rule “given the benefits to competition and healthcare
Devices
FDA has granted Sensydia a breakthrough device designation for its Cardiac Performance System (CPS) that measures critical cardiac function. The cardiac monitoring device is designed to report critical heart performance measurements to physicians for comprehensive evaluation of patients with advanced and persistent heart failure, without requiring an in-hospital catheterization
Devices
FDA will provide an overview of its draft guidance, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations, in a free 90-minute 2/10 Webinar. Topics to be covered in the Webinar include an overview of digital health technologies (DHT); regulatory considerations for DHTs for remote data acquisition
Devices
Getinge has recalled its Vaporizer Sevoflurane Maquet filling due to the potential chemical breakdown of Sevoflurane, a general surgical anesthetic. A recall notice says that if the chemical breakdown occurs, it could result in inhalation of, or skin exposure to, harmful chemicals that may cause serious patient harms, including irritation
Devices
CDRH has released its Health of Women Program Strategic Plan that intends to boost related regulatory science, and identify and address current and emerging issues in medical device research and regulation. The plan identifies three strategic priorities to guide the Center’s “understanding of how medical devices work for women
Devices
Medtronic says three-month results from a clinical trial showed meaningful pain relief using DTM SCS endurance therapy, a modified lower-energy version of its Differential Target Multiplexed (DTM) Spinal Cord Stimulation (SCS) therapy for chronic overall back or leg pain. The company says DTM SCS endurance therapy enables long-
Drugs
A 1/12-2/18/21 FDA inspection at Sunstar Americas’ drug and medical device manufacturing facility in Schaumburg, IL, found significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals and Quality System regulations for medical devices. A just-released 12/21/21 Warning Letter says specific
Devices
FDA and the medical device industry have reportedly come to a standstill in their negotiations on the next five-year iteration of the medical device user fee agreement. A 1/15 deadline to submit their negotiated final commitment letter to Congress has come and gone without the two parties budging
Devices
FDA has cleared a Nextremity Solutions 510(k) for its InCore Subtalar System, indicated for reduction and internal fixation of arthrodeses, osteotomies, and nonunions of the bones and joints of the foot. The device provides surgeons with a three-part intraosseous fixation option for subtalar joint arthrodesis, according to the
Devices
FDA has released the first nine safety summaries developed by the agency and ECRI from a comprehensive literature search and systematic review to identify the current state of knowledge about medical device material performance after implantation. The summaries are for materials that are commonly used in implantable medical devices and
Devices
FDA has updated its 12/2020 safety communication on Endologix’s AFX endovascular graft systems used in treating abdominal aortic aneurysms (AAA) and the risks associated with Type III endoleaks with the devices. The update includes an information summary from the agnecy’s 11/2021 advisory committee meeting and new
Devices
FDA has approved Mentor’s MemoryGel Boost Breast Implant for breast augmentation in women at least 22 years old, and for women of all ages undergoing breast reconstruction. The company says the device features its “proprietary highly cohesive gel, an innovative implant shell design and precision fill ratio, the combination
Devices
FDA has approved a request from the Florida state government to extend the expiration date on hundreds of thousands of expired Covid test kits by three months into March. Florida News reports the state’s Division of Emergency Management has between 800,000 and one million test kits that had
Devices
FDA has cleared an Abbott 510(k) for the EnSite EP System with EnSite Omnipolar Technology (OT), a new cardiac mapping platform designed to help physicians better treat cardiac arrhythmias. The device creates “highly detailed” three-dimensional maps of the heart to help physicians identify and then treat areas of
Devices
FDA has approved a Cochlear Limited PMA for its Cochlear Nucleus Implants for treating unilateral hearing loss and single-sided deafness. According to the company, unilateral hearing loss is classified as hearing loss in one ear and near to near-normal hearing in the opposite ear, and single-sided deafness
Devices
FDA says consumers should stop using the LuSys Laboratories Covid-19 antigen test (nasal/saliva) and Covid-19 IgG/IgM antibody test because their performance has not been adequately established and there is a high risk of false results from the tests. An agency safety communication says neither test has