Devices
FDA has cleared an Alphatec Holdings 510(k) for the SafeOp neuromonitoring system for use in real-time intraoperative nerve location and health assessments during spinal surgery. The company describes the device’s next-generation technology advances as two intraoperative neurophysiological monitoring modalities: somatosensory evoked potential (SSEP), and electromyography (EMG)
Devices
FDA has cleared a Spirosure 510(k) for its Fenom Pro Asthma Monitor for use by allergists, immunologists and pulmonologists to help patients manage asthma by measuring the fraction of exhaled nitric oxide (FeNO) in their patients’ breath. FeNO is an established biomarker for airway inflammation in human exhaled breath,
Devices
FDA has released a draft guidance entitled “Implanted Brain-Computer Interface (BCI) 1 Devices for Patients with Paralysis or Amputation – Non-clinical Testing and Clinical Considerations.” The document provides non-clinical testing and clinical study design recommendations associated with implanted BCI devices. The scope of this document is limited to
Devices
ICU Medical has begun a Class 1 recall of one lot of ChemoLock Vial Spikes, 20mm due to the potential for plastic particles to break off the protective cap. “In uncommon circumstances a plastic particle could enter the drug delivery system and be infused into a patient's intravenous
Devices
FDA has approved a Biotronik PMA for its Orsiro drug-eluting stent (DES) system. The company says the device is the first DES to outperform the clinical standard, Abbott’s Xience. Orsiro is indicated for use in percutaneous coronary intervention procedures. The cobalt chromium metal stent elutes sirolimus via BIOlute,
Devices
A 3/19-4/13/18 FFDA inspection at American Preclinical Services, Minneapolis, MN, found violations of Good Laboratory Practice regulations in the company’s participation in several nonclinical laboratory studies. A 2/12 Warning Letter corrects a Warning Letter issued 10/4/18. Inspection observations listed on an FDA-
Devices
FDA has cleared an Intuitive Surgical 510(k) for the Ion endoluminal system to enable minimally invasive biopsies in the peripheral lung. The device uses an ultra-thin articulating robotic catheter that can move 180 degrees in all directions. “The outer diameter of the catheter is 3.5 mm, which
Devices
FDA has cleared an Axilum Robotics 510(k) for the TMS-Cobot TS MV, indicated for the spatial positioning and orientation of the MagVenture Transcranial Magnetic Stimulation (TMS) Therapy system treatment coil. The device is based on the company’s new platform that uses a proprietary optical tracking system, which
Devices
FDA has issued a guidance, Acceptance and Filing Review for Premarket Approval Applications (PMAs), to help describe the broad preclinical and clinical issues that need to be addressed in a PMA and the key decisions to be made during the filing process. The document says that focusing the agency’s
Devices
FDA has issued a guidance, Refuse to Accept Policy for 510(k)s, to explain the procedures and criteria FDA intends to use in assessing whether a 510(k) submission meets a minimum threshold of acceptability and should be accepted for substantive review. “Focusing FDA’s review resources on complete
Devices
FDA is reminding stakeholders that 2/21 is the effective date for compliance with the final rule on Human Subject Protection; Acceptance of Data from Clinical Investigations for Medical Devices. The agency says the change will require that data submitted from clinical investigations outside the U.S. to support an
Devices
FDA has cleared an Agfa 510(k) for the DR 800 multipurpose imaging system with tomosynthesis. The device is intended to be one solution for radiography, fluoroscopy, multi-slice and advanced clinical applications. “With the DR 800, Agfa moves from 2D single plane imaging to multi-slice image reconstruction. Tomosynthesis
Drugs
An FDA final guidance on coordinated development of antimicrobial drugs and antimicrobial susceptibility test (AST) devices intends to describe the interactions that are needed to achieve coordinated development of applications submitted to CDER and CDRH, according to CDRH Division of Microbiology Devices branch chief Ribbi Shawar. Speaking at a CDRH
Devices
CDRH associate director for digital health Bakul Patel says the 1/7 release of version 1.0 of the Center’s pre-certification working model also included release of a test plan and regulatory framework. In a 2/7 Webinar on the releases, Patel said that in version 1.0
Devices
FDA has cleared a Royal Philips 510(k) for the DigitalDiagnost C90, its newest digital radiography system. The device is designed to increase patient throughput and decrease the time to diagnosis, the company says. DigitalDiagnost is described by Royal Philips as the industry’s first radiography unit with a live
Devices
Pharmaceutical Research and Manufacturers of America has given FDA four points to consider when revising its draft guidance on developing and labeling in vitro companion diagnostic devices for a specific group or class of oncology therapeutic products. The association says that: * any final guidance should clarify that class labeling is
Devices
The federal government has intervened in a False Claims Act case alleging that Alere’s Arriva Medical unit submitted or caused false claims to be submitted to the Medicare program for medically unnecessary glucometers and paid kickbacks to Medicare beneficiaries in the form of free glucometers and copayment waivers. The
Devices
FDA has granted Medtronic a breakthrough device designation for its investigational Personalized Closed Loop (PCL) insulin pump system. The company says the PCL technology is designed to automate insulin delivery in real-time, personalized and by adapting to the user. The system is also being designed to provide insights and
Devices
FDA has issued a draft guidance on Nonbinding Feedback After Certain FDA Inspections of Device Establishments, which proposes a process where device companies can request nonbinding agency feedback on certain kinds of documented inspectional observations that are issued on a Form 483. The document outlines a standardized method for communicating
Devices
FDA has finalized two guidance documents on regenerative medicine therapies that were issued as drafts 11/2017 as part of the agency’s comprehensive regenerative medicine policy framework. The first guidance, Evaluation of Devices Used with Regenerative Medicine Advanced Therapies, is intended to clarify how the agency will evaluate devices
Devices
FDA has classified as Class 1 a Medtronic recall of its Dual Chamber Implantable Pulse Generators due to the possibility of a software error that can result in a lack of pacing. The implanted cardiac pacemakers are used to provide stimulation to increase heart rate in patients with a slow
Devices
An 8/22-9/26/18 FDA inspection at Circulatory Technology, Oyster Bay, NY, found Quality System Regulation violations in the firm’s work as a specification developer of the Better Bladder and Bigger Better Bladder medical devices. A just-released 1/28 Warning Letter says the violations were: * failing