Devices
FDA has issued an immediately effective guidance, Enforcement Policy for Certain Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions, saying the agency will not object to certain limited modifications within the scope of the guidance being implemented with a retrospective update in the next periodic report.
Devices
A 3/23-3/29 FDA inspection at WAVi Co. in Denver, CO, found that the firm manufactures and distributes the “WAVi Desktop,” intended to collect, analyze, and clinically interpret data to aid in the assessment or diagnosis of patients with a variety of potential neurological conditions. A 10/20
Devices
Pharmaceutical Research and Manufacturers of America and the Biotechnology Innovation Association say they appreciate FDA’s timely publication of its information technology (IT) strategy and its efforts to meet its commitments under the most recent PDUFA and BsUFA agreements, as well as requirements under the FDA Omnibus Reform Act of
Devices
Responding to an Office of the National Cyber Director request for information on opportunities for and obstacles to harmonization of cybersecurity regulations, AdvaMed points out that FDA “is the primary authority in regulating medical devices, including establishing that they are cyber secure. FDA administers comprehensive regulations and implementing guidance that
Devices
Asensus Surgical has recalled (Class 1) its Senhance Surgical System due to the potential for the devices to malfunction. The company has identified a malfunction that has occurred and may recur involving “uncontrolled arm motion of the Laparoscope Instrument Actuator (LIA) where the LIA rotated continuously in one direction after
Devices
The Advanced Medical Technology Association (AdvaMed) is urging FDA to proceed with stakeholder recommendations to develop a “central item bank or horizontal PRO [patient-reported outcomes]” tool for all vision disease states in clinical trials. AdvaMed’s comments were submitted to the docket of a 9/29 FDA virtual public
Devices
FDA has approved Impulse Dynamics’ Optimizer Smart Mini system for whole-body MRI-conditional use. Impulse Dynamics says the device is used to deliver the company’s proprietary cardiac contractility modulation (CCM) therapy. The approval expands the product labeling to allow for full-body magnetic resonance diagnostic imaging with 1.
Devices
Cardinal Health has recalled (Class 1) certain lots of its Monoject luer-lock tip syringes (1, 6, 12, 20, 35 and 60 mL) after the company documented recognition and compatibility issues with certain syringe infusion pumps. As a result, Cardinal Health recommends that the affected devices not be used with
Devices
FDA has granted Paige a breakthrough device designation for its Paige Lymph Node, an artificial intelligence (AI) application used to detect breast cancer metastases in lymph node tissue. The company says the device is the first AI application of its kind to receive a breakthrough designation from the agency. “Pathologic
Devices
Olympus has recalled (Class 1) its high-flow insufflation units (model UHI-4) that are used in laparoscopic surgeries after receiving reports about patients suffering arrhythmias, described as short cardiac arrests, during surgical procedures where the devices were used. “These events may have been due to an over-insufflation of
Devices
Researchers from several academic medical centers say FDA should consider making some changes to its Breakthrough Devices Program (BDP) to prevent it from triggering Centers for Medicare and Medicaid Services (CMS) supplemental payments for many costly, new devices. Writing in a JAMA Cardiology Special Communication, the researchers say (article purchase
Devices
Qiagen and Myriad Genetics say they have a master collaboration agreement to develop cancer companion diagnostic tests. A Myriad statement says the partnership aims to deliver innovative services and products to pharmaceutical companies, enabling the development and commercialization of proprietary cancer tests for the U.S. clinical market, and providing
Devices
Sens. Charles Grassley (R-IA) and Elizabeth Warren (D-MA) have written to FDA commissioner Robert Califf urging that the device identifier (DI) portion of a medical device’s unique device identifier be included on Medicare claim forms. “Given the decades-long effort to include DI information on Medicare claims
Devices
FDA has approved Medinol’s EluNIR-PERL drug-eluting stent for treating coronary artery disease. The next-generation stent features four radiopaque markers, two at each end of the stent, and a hybrid polymer-metal radiopaque catheter tip, according to the company, which provides “outstanding visualization” during PCI procedures and
Devices
FDA has cleared a Denti.AI 510(k) for its Denti.AI Detect, which the company describes as a “state-of-the-art imaging solution” engineered to aid dental professionals in identifying prevalent dental diseases such as caries, periapical lesions, and bone loss from dental x-rays. The clearance was
Drugs
Attorney Dara Katcher Levy (Hyman, Phelps & McNamara) says an FDA 10/23 draft guidance on communications from firms to healthcare providers about scientific information on unapproved uses of approved/cleared medical products represents a shift in the agency’s approach. Writing in her firm’s online FDA Law Blog,
Devices
ResMed Ltd. has recalled (Class 1) its Astral 100 and Astral 150 ventilators due to what FDA calls a “device design” issue. If an affected ventilator is running on its internal battery, which is not intended to serve as a primary power source, the device’s low/critically low battery
Devices
FDA, Health Canada, and the UK’s Medicines and Healthcare Products Regulatory Agency have published five guiding principles for predetermined change control plans (PCCPs) for machine learning-enabled medical devices (MLMDs). An FDA post says the principles “draw upon the overarching good machine learning practice guiding principles the three agencies
Devices
FDA has approved a Medtronic PMA for the Aurora EV-ICD MRI SureScan (Extravascular Implantable Cardioverter-Defibrillator) and Epsila EV MRI SureScan defibrillation lead for treating fast heart rhythms that can lead to sudden cardiac arrest. “The Aurora EV-ICD system is the first-of-its-kind to provide the
Devices
Fresenius Medical Care is recalling (Class 1) some of its 2008 series hemodialysis machines because patients may be exposed to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) that leach from some peroxide-cured silicone tubing used in the machines. “Data provided by the manufacturer indicates that the amount of
Drugs
FDA has approved a new indication for Servier Pharmaceuticals’ Tibsovo (ivosidenib) to treat adults with relapsed or refractory (R/R) myelodysplastic syndromes (MDS) with an isocitrate dehydrogenase-1 (IDH-1) mutation as detected by an FDA-approved test. An agency statement says this is the first targeted therapy approved for
Devices
FDA has reposted a Medtronic notice warning healthcare professionals about stolen defective McGrath MAC video laryngoscopes that have been offered for sale illegally by unauthorized third parties through various social media platforms. The affected products “did not pass Medtronic’s rigorous quality tests” and were designated for destruction, the notice