Devices
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) says doctors should not use paclitaxel drug-coated balloons or drug-eluting stents in routine treatment of patients with intermittent claudication until further notice, as the potential mortality risk outweighs the benefits. An agency medical device alert says use of the
Devices
FDA has approved a DT MedTech PMA for the Hintermann Series H3 Total Ankle Replacement System. The three-piece, mobile-bearing implant is indicated for use as a non-cemented implant to replace a painful arthritic ankle joint due to primary osteoarthritis, post-traumatic osteoarthritis or arthritis secondary to inflammatory
Devices
The National Evaluation System for health Technology Coordinating Center (NESTcc) says it is opening 12 new test cases to leverage real-world evidence and address key priorities for medical device stakeholders. A NESTcc statement says the test cases are intended to accelerate the organization’s progress and provide proof of
Devices
ECA Academy says a recent FDA Warning Letter “gives very nice insights into the state of the art regarding cleaning validation from the point of view of FDA.” The Warning Letter was issued 4/23 to Laboratoires Clarins, Pontoise, France. The ECA analysis says the agency criticized that the company
Devices
Hamilton Medical is updating all Hamilton-G5 Ventilators that contain software versions 2.60 or older to prevent the user message “panel connection lost” and the device entering an ambient state. “The user error message is due to a blocked or terminated communication between the ventilation unit processor and the
Devices
FDA has approved a Zavation 510(k) to market the Ti3Z Interbody System, a lumbar intervertebral body fusion device. The device is indicated for spinal fusion procedures and used with autogenous bone graft in skeletally mature patients. The implants are intended for use at either one level or two contiguous
Devices
FDA has cleared a ReWalk Robotics 510(k) for the ReStore soft exo-suit system for use in treating stroke survivors with mobility challenges. The device comprises a soft, garment-like design which connects to a lightweight waist pack and mechanical cables that help lift a patient’s affected leg
Drugs
A presentation by staff from FDA and Harvard Medical School on “Medical Product Safety: Ten Years of the U.S. Sentinel System” gives the history and operations of the Sentinel System. FDA uses Sentinel to: (1) evaluate safety signals identified during the premarket review of new drug applications; (2) evaluate
Devices
FDA has cleared a Misonix 510(k) for Nexus, an ultrasonic surgical platform. The company says its next-generation integrated device combines all the features of Misonix’s existing features, including BoneScalpel, SonicOne and Sonastar, into an integrated platform that will also serve to power future options. Nexus is driven
Devices
FDA has approved a TransMedics Group PMA for expanded clinical indications of the Organ Care System Lung to be used for the preservation and ex-vivo assessment of both standard criteria donor lungs as well as the larger pool of donor lungs initially deemed unacceptable for procurement and transplantation based
Devices
FDA has approved a Stryker PMA for the Neuroform Atlas Stent System, an aneurysm adjunctive stent for treating wide-neck, intracranial aneurysms in conjunction with embolic detachable coils. The device was previously approved under a humanitarian device exemption restricting use to specific hospitals with institutional review board approval. Approval was
Devices
FDA has cleared a Medivis 510(k) for its SurgicalAR, an augmented reality technology platform for surgical applications and its clinical use in the operating room. The company says the device “integrates the latest advancements in augmented reality, artificial intelligence, and computer vision to advance surgical visualization, thereby decreasing surgical
Devices
FDA has granted Resolution Bioscience a Breakthrough Device Designation for the Resolution HRD liquid biopsy assay, a qualitative in vitro diagnostic to detect sequence variations in key genes related to homologous recombination deficiency for single nucleotide variants, indels, and copy number variants. The company says it plans to seek device
Devices
Terumo Medical has recalled its Solopath Balloon Expandable TransFemoral System and Re-Collapsible Balloon Access System due to the potential for the tip to dislodge from the outer rim of the sheath resulting in a loss of the smooth transition from the surface of the tip to the outer surface
Drugs
A recent updated Justice Department guidance intended to help department prosecutors evaluate corporate compliance programs in the context of investigations of business entities confirms that three fundamental issues are relevant to any such evaluation. Attorneys Gregory Brower and Stanley Garnett (Brownstein Hyatt Farber Schreck) write in a Washington Legal Foundation
Devices
FDA has cleared a Medtronic 510(k) for the SelectSite C304-HIS deflectable catheter system for use in procedures involving His-bundle pacing. The device features a deflectable, out-of-plane curve to reach the bundle of His and is designed to “enable enhanced range maneuverability, fixation and implant success
Devices
Integra LifeSciences has recalled its LimiTorr and MoniTorr Drainage Systems due to complaints on “piece breaking off at connection point,” “broken manifold-stopcock,” “stopcock problem,” “connection where the external transducer is attached to the transducer holder bracket broke off,” and “transducer attachment on the LimiTorr/MoniTorr has cracked and was
Devices
Edwards Lifesciences has recalled its EV1000A, EV1000NI, EV1000CS EV100 Clinical Platforms due to the potential for fluids to leak into the AC power outlet. The devices are used to monitor patients’ blood pressure and pulse during and after surgery. “Use of these products can result in electrical short circuit, which
Devices
FDA has cleared a CD Diagnostics de novo marketing request for the Synovasure Lateral Flow Test Kit to serve as an aid for detecting periprosthetic joint infection (infection around a joint replacement) in the synovial (lubricant) fluid of patients being evaluated for revision surgery, which is surgery performed to replace
Devices
FDA has approved a Novocure humanitarian use device for NovoTTF-100L System in combination with pemetrexed plus platinum-based chemotherapy for the first-line treatment of unresectable, locally advanced or metastatic, malignant pleural mesothelioma (MPM). NovoTTF-100L is an antimitotic cancer treatment that delivers “tumor treating fields” to the tumor
Devices
FDA says it has cleared a modified Erbe USA Erbeflo port connector to help reduce risk of endoscope cross-contamination. An agency notice says the design of the modified Erbeflo 24-hour use port connector added a backflow prevention feature as recommended in FDA guidance for reducing the risk of
Devices
FDA has issued a safety alert on a Class 1 recall of Beckman Coulter’s DxH 800, DxH 600 and DxH 900 hematology analyzers, which perform blood tests to diagnose diseases and conditions such as anemia, infections, blood clotting problems, blood cancers and immune system disorders. The agency says the