Drugs
While FDA continues to sift through public comments it requested (see earlier story) about how to comply with a court decision and move certain contrast agents from being regulated as drugs to devices, a new “legal insight” post sees Congress eventually stepping in to clarify that all contrast agents remain
Devices
FDA has approved a CartiHeal PMA for its Agili-C implant, indicated for treating an International Cartilage Repair Society (ICRS) Grade III or above knee-joint surface lesion with a total treatable area of 1-7cm2 and without severe osteoarthritis. Approval was based on data from a two-year IDE
Devices
FDA has approved Edwards Lifesciences’ Mitris Resilia valve, a tissue valve replacement specifically designed for the heart’s mitral position. The company says the valve has a “saddle-shaped sewing cuff that mimics the asymmetric shape of the native mitral valve. It also features a low-profile frame that helps
Devices
FDA says Magellan Diagnostics has resumed distribution of its LeadCare II product that was previously unavailable. The LeadCare Plus and LeadCare Ultra products are currently unavailable, an agency update says. FDA announced on 5/28/21 a Class I Magellan recall of its LeadCare II, LeadCare Plus, and LeadCare Ultra
Devices
Medtronic has recalled a subset of IN.Pact Admiral and IN.Pact AV paclitaxel-coated percutaneous transluminal angioplasty balloon catheters due to the potential for pouch damage and a resulting loss of sterility. The company says that during a routine inspection, it detected damage to the sterile pouch that contains
Devices
FDA has cleared a Sky Medical Technology 510(k) for its new (W3) geko device for increasing microcirculatory blood flow in lower limb soft tissue of patients with venous insufficiency or ischemia. The (W3) device follows the company’s 2021 FDA-cleared (W2) geko device, which was also authorized for
Devices
The Department of Homeland Security Cybersecurity & Infrastructure Security Agency (CISA) has issued a 3/29 medical advisory on the Philips e-Alert MRI system monitoring platform version 2.7 and prior. The advisory says the e-Alert is missing authentication for a critical function and successful exploitation of this
Devices
AdvaMed says an FDA draft guidance on assessing the credibility of computational modeling and simulation in medical device submission “is an important step toward highlighting the importance of rules and physics-based modeling and simulation in the form of evidence in a regulatory submission.” The association’s comment letter says
Devices
FDA has cleared a Biobeat 510(k) for its wearable remote patient monitoring device to monitor respiratory rate and body temperature in addition to cuffless blood pressure, blood oxygen saturation and pulse rate. The medical grade wearable monitors use proprietary non-invasive reflective photoplethysmography monitoring technology to automatically and continuously
Drugs
Several drug and medical device industry stakeholders have submitted comments on an FDA draft guidance on digital health technologies for remote data acquisition in clinical investigations. Pharmaceutical Research and Manufacturers of America (PhRMA) says it supports the agency’s ongoing efforts to facilitate the use of digital health technologies in
Devices
AdvaMed says it commends FDA efforts to develop a proposed transition plan for medical devices that fall within enforcement policies issued during the Covid-19 public health emergency. In its comment letter, AdvaMed says the agency draft guidance “is a crucial step to help avoid disruption in device supply. At
Devices
FDA has approved a Staar Surgical PMA for the EVO/EVO+ Visian Implantable Collamer Lens (ICL) for correcting myopia and myopia with astigmatism. “The EVO lens is additive, provides excellent quality of vision day and night, does not cause dry eye syndrome and is removable by a doctor,” the company
Devices
FDA has cleared a Cutera 510(k) for AviClear, a laser treatment for mild, moderate, and severe acne. “In addition to reducing existing acne, clinical trials show that future breakout episodes are shorter, less intense, and more infrequent following the AviClear procedure,” according to the company. Further, it says acne
Devices
The House Oversight and Reform committee is seeking answers to what FDA regulatory enforcement actions have been sought against Medtronic’s troubled HeartWare Ventricular Assist Device (HVAD) System — a heart pump device associated with more than 20,000 patient injuries and 3,000 deaths before it was recalled 6/2021
Devices
CDRH director Jeffrey Shuren says he would like to see legislative changes that would give the Center greater regulatory flexibility in dealing with artificial intelligence/machine learning (AI/ML)-driven medical devices. Speaking to a 3/22 Duke Margolis Center for Health Policy Webinar on regulation, development, and real-world
Drugs
FDA approved 3/23 Novartis’ Pluvicto (lutetium Lu 177 vipivotide tetraxetan) to treat adults with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer who have been treated with androgen receptor pathway inhibition and taxane-based chemotherapy. An agency notice says concurrent approval was granted for the company’
Devices
FDA has cleared an Artio Medical 510(k) for its Solus Gold Embolization Device for peripheral vascular occlusion. The company says the Solus device offers advantages over current occlusion devices and their difficulties being positioned in challenging anatomies, which often require multiple implants. “The Solus Gold device aims to overcome
Devices
A 9/15-9/26/21 FDA inspection at Unimicro Medical Systems-Shenzhen Co., Shenzhen, China, found Quality System Regulation violations in the firm’s manufacturing of Veress pneumoperitoneum needles. A just-released 1/6 Warning Letter says specific violations were: * failing to adequately establish and maintain procedures to control
Devices
FDA and representatives of the medical device industry have reached an agreement on provisions to send to Congress to reauthorize MDUFA. An FDA announcement says that under the agreement, the agency would be authorized to collect at least $1.78 billion in user fees over five years, plus additional funding,
Devices
FDA has cleared a Quantum Surgical 510(K) for its Epione, described as a new category of interventional oncology robotics dedicated to liver cancer treatment. The robotic-assisted device is designed to plan, target, deliver and confirm tumor ablation. “Epione enables clinicians to perform safe and effective percutaneous tumor ablations,
Devices
FDA is offering “conservation strategies” for healthcare professionals using prefilled 0.9% sodium chloride (saline) intravenous (IV) lock/flush syringes due to potential supply shortages. The devices are in shortage “because of an increase in demand during the Covid-19 public health emergency, as well as recent vendor supply chain
Devices
FDA has classified as Class 1 a Philips Respironics recall of certain V60 and V60 Plus ventilators because some of the devices had parts that were put together using an expired adhesive. “If the adhesive fails, it could cause a capacitor support bracket to become loose and potentially damage the