Devices
FDA has cleared a 4WEB Medical 510(k) for its Lateral Spine Truss System, a 3D-printed lateral interbody fusion device. “4WEB’s proprietary truss implant technology leverages fundamental engineering principles in structural mechanics to address important clinical issues such as implant subsidence after lateral access surgery,” a news release
Devices
FDA has issued a guidance, Adaptive Designs for Medical Device Clinical Studies, to give sponsors suggestions on how to plan and implement adaptive designs for clinical studies when used in medical device development programs. The document defines an adaptive design for a medical device clinical study as a clinical study
Devices
FDA has issued a draft guidance, Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices, to clarify how the agency uses real-world data to determine whether it may be sufficiently relevant and reliable to generate the types of real-world evidence that can be used
Devices
CDRH says early feasibility studies conducted in the U.S. can give medical device developers important FDA feedback early in the development process, which may improve the development strategy and reduce the chances that unnecessary testing is completed. Speaking on a device clinical trial webinar (view recording/view transcript) earlier
Drugs
The stakes are increasing for drug, biologic and medical device companies exposed to False Claims Act (FCA) lawsuits that are often brought by whistleblowers. Effective 8/1, the Department of Justice (DoJ) will nearly double the per-claim penalties it imposes under the FCA. According to a recent interim final
Devices
Attorney Gail Javitt (DLA Piper) says that a recent FDA draft guidance on agency oversight of certain applications of next generation sequencing (NGS)-based technology leaves several threshold questions unanswered. Writing in an online post, Javitt says that the standards proposed in the guidance address areas including test design considerations,
Devices
Democratic leaders on the House Energy and Commerce Committee are asking FDA and the Centers for Medicare and Medicaid Services (CMS) for information on how regulators are working with Theranos to ensure that the company complies with federal regulatory standards and addresses concerns about its flawed blood test results. Letters
Devices
FDA has cleared a BioTelemetry 510(k) for its next generation Mobile Cardiac Outpatient Telemetry device, the MCOT Patch. The Patch is a four-lead, two-channel system that, through the use of a proprietary algorithm, provides remote arrhythmia detection. The device incorporates proprietary “patch technology” that the company recently
Drugs
Continued government losses in lower courts involving First Amendment-related off-label drug marketing cases raise the specter that FDA’s entire pre-market approval regime could be in jeopardy, according to University of Arizona law professor Christopher Robertson. Writing in an Arizona Legal Studies discussion paper, Robertson notes how
Devices
FDA has posted a draft guidance on “Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI)” that defines the expected content and forms to assist both labelers and FDA-accredited issuing agencies. The document is intended to ensure the UDI issuers are in compliance with the
Devices
Carefusion has recalled certain lots of its Diamond-Flex Circular Retractor, Angled, 40mm and 5mm devices. A recall notice says the firm identified a potential risk associated with a weld failure which could result in the wire protruding through the tip of the instrument when articulated. If this failure were
Devices
Johnson & Johnson subsidiary Acclarent has agreed to pay $18 million to settle a federal whistleblower false claims lawsuit alleging that the company marketed a sinus device for a drug delivery use not approved by FDA, and causing healthcare providers to submit false claims to Medicare and other healthcare programs.
Devices
FDA has classified as Class 1 a Stryker Sustainability Solutions (formerly Ascent Healthcare Solutions) recall involving its Flush Angiographic Catheter due to tip separation. The device is used to inject contrast dye into blood vessels in preparation for a cardiac angiogram. The recall was ordered due to reports about the
Devices
FDA’s Clinical Chemistry and Clinical Toxicology Devices Panel voted 8 to 2 to support approval for Dexcom’s G5 Mobile continuous glucose monitoring system and its use as a replacement for fingerstick glucose monitoring in patients with diabetes. Currently, the device is indicated for adjunctive use along with self-
Devices
FDA has approved an Asuragen de novo submission to allow marketing of the QuantideX qPCR BCR-ABL IS Kit, the first nucleic acid-based quantitation test for use during treatment of chronic myeloid leukemia (CML) patients. The device uses blood specimens from patients with CML to measure the amount of
Devices
FDA has approved a Vasorum Ltd. PMA for the Celt ACD vascular closure device, indicated for arterial puncture closure in both diagnostic and anticoagulated percutaneous interventional cardiology and radiology patients. The device comes in three sizes for safe and effective closure of 5F, 6F and 7F punctures. It was “designed
Devices
FDA has cleared a Relievant Medsystems 510(k) for the Intracept Intraosseous Nerve Ablation System for relieving chronic low back pain that has not responded to at least six months of conservative care and was caused by changes associated with degeneration of spinal vertebral bodies and the nearby intervertebral discs.
Drugs
EG Lifesciences says that companies should have a site inspection readiness team on hand and ready to take action whenever FDA inspectors arrive for an announced or unannounced visit. Once inspectors arrive, a recent online post says, companies should use the following checklist for key logistical considerations: * be sure that
Devices
FDA has cleared a Medtronic 510(k) for the CD Horizon Fenestrated Screw Set, a cement-augmented pedicle screw which can be used for patients diagnosed with advanced stage tumors involving the thoracic and lumbar spine. The device is intended for use at spinal levels where structural integrity is not
Devices
Despite objections from congressional Republicans, FDA is moving ahead with plans to finalize guidelines for regulation of laboratory-developed tests by the end of this year, according to the online political Web site The Hill. The report says that Republicans on the House Energy and Commerce and Appropriations committees warned
Devices
The former chief executive officer and vice president of sales at medical device company Acclarent have been acquitted by a Boston jury involving felony charges that the two illegally marketed a medical device for off-label uses. While cleared of the felony charges, the jury did find the two guilty
Drugs
A Health Affairs blog post urges FDA to publish guidance on off-label promotion in the wake of recent First Amendment court cases that have questioned the agency’s authority to regulate off-label information. “Given the competing interests of patient health, access to information, drug safety, and the financial