Devices
FDA will publish in the 1/17 Federal Register a notice proposing to implement regulations on internal agency supervisory review of certain decisions related to medical devices regulated by CDRH to conform to applicable provisions of the FDA Safety and Innovation Act and the 21st Century Cures Act. The notice
Devices
FDA has released a guidance on “Unique Device Identification (UDI): Policy Regarding Compliance Dates for Class I and Unclassified Devices.” The agency’s UDI system is designed to identify devices though distribution and use. System requirements are being phased in over seven years according to established compliance dates based primarily
Drugs
FDA is delaying the effective date of portions of a final rule that would have revised the agency’s existing regulations describing the types of evidence that may be considered in determining a medical product’s intended use. Comments to FDA from stakeholders complained that the proposed changes were not
Devices
FDA is giving healthcare providers information about reports of pneumothorax events associated with feeding tube placement procedures using enteral access systems. A MedWatch notice says most reports indicate the pulmonary events required urgent intervention, including needle decompression or chest tube placement. Several of the events were associated with cardiopulmonary arrest
Devices
FDA has issued Becton Dickinson a Warning Letter as part of its investigation of Vacutainer blood collection tubes used in Magellan Diagnostics LeadCare and LeadCare II blood lead testing systems, citing concerns that they may underestimate blood lead levels and give inaccurate results when processing venous blood samples (see earlier
Devices
Edwards LifeSciences has recalled its Certitude Delivery System due to a molding overflow defect in the button valve within the loader. “The overflow material could detach during placement of the delivery system and potentially embolize into the patient,” a recall notice says. The device is used for delivery of the
Devices
David M. Link, the founding director of FDA’s Bureau of Medical Devices (1974-80), precursor organization of CDRH, died 12/23/17 in Massachusetts General Hospital at the age of 87. A Massachusetts Institute of Technology physics graduate, Link’s career at FDA preceded formation of the Bureau, coming
Devices
FDA has approved Medtronic’s new clinician programmer for use with the SynchroMed II Intrathecal Drug Delivery system, an implantable pump that provides targeted drug delivery for chronic pain and severe spasticity. The pump delivers medication directly to the fluid around the spinal cord, which provides relief at lower doses
Devices
FDA has cleared a Masimo 510(k) for home use of the Rad-97 Pulse CO-Oximeter . The device provides continuous monitoring through its Measure-through Motion and Low Perfusion SET pulse oximetry and upgradeable rainbow technologies. It also offers advanced connectivity and communication capabilities for telehealth applications, the company
Devices
FDA has cleared an Attune Medical 510(k) for its EnsoETM, a device capable of administering tube feeds or medication while simultaneously cooling or warming patients using the esophageal space. “The newly-cleared model of EnsoETM, which manages patient temperature through the esophagus, allows for enteral fluid administration with the
Devices
Medical devices using the humanitarian device exemption (HDE) approval pathway are exempt from the typical requirement to demonstrate a reasonable assurance that the device is safe and effective. CDRH staff said in a 12/18/17 Webinar on the HDE pathway that sponsors using this pathway need to demonstrate that
Devices
FDA has provided de novo clearance for IlluminOss Medical’s IlluminOss Bone Stabilization System for treating impending and actual pathological fractures of the humerus, radius and ulna caused by metastatic bone disease. The device uses a thin-walled polyester polyethylene terephthalate balloon that is infused with a liquid monomer and
Devices
Pulmonx Corp. has filed a PMA for the Zephyr Endobronchial Valve (EBV), a removable device designed to treat severe emphysema. The company says Zephyr is the only device designed for emphysema that has a clinically-validated diagnostic tool – the Chartis System – which can identify likely responders in order to optimize
Drugs
FDA commissioner Scott Gottlieb says 2017 was “an inspiring year of advances in both medicine and public health for FDA, from groundbreaking medical products brought to market this year to a record number of generic drug approvals that will promote competition, and to the agency’s ongoing efforts to advance
Devices
FDA has cleared an STS Medical 510(k) for its composite sinus stent. The device is intended to reduce recurrent surgeries after functional endoscopic sinus surgery, which is often performed to increase airflow within the nose and sinuses, improve drainage, and remove diseased tissue. The company says that up to
Devices
BioCardia has filed an IDE for the CardiAMP Chronic Myocardial Ischemia (CMI) Trial to treat patients with refractory angina. The device uses a patient’s own cells for treating CMI. “This therapeutic approach of focused implantation of the right combination of bone marrow-derived cells delivered intramyocardially for the treatment
Devices
FDA has approved Roche’s cobas Plasma Separation Card, a sample collection device for HIV plasma viral load testing. Previously, plasma viral load results required blood samples to be cooled during transport to the lab. The new device allows quantitative testing of patients with HIV living in remote areas affected
Devices
FDA has cleared a Mevion Medical Systems 510(k) clearance for the Mevion S250i Proton Therapy System that uses its Hyperscan pencil beam scanning (PBS) technology. The technology uses energy layer switching and automated collimation systems to deliver faster, sharper, and more robust PBS proton radiation treatments, the company says.
Drugs
The Justice Department says it obtained more than $3.7 billion in settlements and judgments from civil cases involving fraud and false claims against the government in FY 2017, with $2.4 billion of the total involving the health care industry. A department news statement says that the health sector
Devices
FDA has cleared a Cerebrotech Medical Systems 510(k) for the Cerebrotech Visor, previously known as the CMS-5000 Intracranial Fluids Monitor. The clearance includes a broad indication for use as an aid in assessing fluid volume differences between the cerebral hemispheres in patients undergoing neurologic assessment. The company says
Devices
FDA has cleared a Zimmer Biomet Holdings 510(k) for the Sidus Stem-Free Shoulder system as a total shoulder arthroplasty solution for patients with good bone stock who have either osteoarthritis, post-traumatic arthrosis, focal avascular necrosis of the humeral head or who had previous surgeries of the shoulder
Drugs
FDA says it is seeking nominations to join the agency’s Patient Engagement Collaborative (PEC). An FDA Voice blog post says the PEC is looking for: * patients who have personal disease experience; * caregivers who support patients, such as a parent, child, partner, other family member, or friend, and who have