Devices
FDA has approved a Qiagen PMA supplement for QuantiFeron-TB Gold Plus, a fourth-generation blood test for detecting latent tuberculosis (TB) infection. The device adds the company’s proprietary CD8+ technology to “offer the ability to capture a much broader picture of an individual’s immune response to TB
Devices
FDA has cleared a W. L. Gore 510(k) for its Gore Synecor Preperitoneal Biomaterial hernia repair device, which offers treatment options for the full range of hernia cases, with configurations for both intraperitoneal and preperitoneal placement. The company says the device’s placement between tissue layers “makes tissue ingrowth
Devices
FDA has cleared an AngioDynamics 510(k) for the Solero Microwave Tissue Ablation (MTA) System, indicated for ablating soft tissue during open procedures. The device features the Solero Microwave (MW) Generator and applicators. The generator, with a 2.45 GHz operating frequency, can power up to 140 watts for “optimized
Devices
FDA has approved an Ethicon PMA for its Surgicel Powder Absorbable Hemostat, which it describes as an “adjunctive hemostatic solution to control continuous oozing on broad or raw surfaces so they can focus on more important issues during surgery.” The device is made of oxidized regenerated cellulose — the same base
Devices
FDA says it is amending regulations to reflect changes enacted into law by the 21st Century Cures Act. A Federal Register notice says that certain requirements related to humanitarian device exemptions (HDE) and institutional review boards (IRB) for devices have changed. The changes are: * allowing for HDE approval for devices
Devices
FDA says the Magellan Diagnostics recall of all lots of its LeadCare and LeadCare II blood lead testing systems manufactured between 9/2013 and the present and distributed between 1/1/14 and 5/22/17 is a Class 1 recall. The company expanded its LeadCare Plus and Ultra Testing
Devices
FDA has cleared a Clarify Medical 510(k) for the Clarify Medical Phototherapy System, a light therapy device for treating diseases such as psoriasis, vitiligo, and eczema. The company says its proprietary technology is designed to allow patients with chronic skin diseases to receive ultraviolet B phototherapy in their homes,
Devices
Bristol-Myers Squibb and Qiagen have entered into an agreement to explore using next-generation sequencing (NGS) technology to develop gene expression profiles (GEPs) as predictive or prognostic tools for use with BMS’ novel immuno-oncology (I-O) therapies in cancer treatment. The companies also plan to enter into a
Devices
FDA has approved a Roche PMA supplement for the cobas CMV (cytomegalovirus) test for use on its automated cobas 6800 and cobas 8800 Systems. The test provides healthcare providers with information to assess how transplant patients on therapy are responding to treatment. “The test is standardized to the 1st WHO
Devices
FDA has allowed the de novo marketing clearance of Claret Medical’s Sentinel Cerebral Protection System to protect against the risk of stroke by capturing and removing debris dislodged during transcatheter aortic valve replacement (TAVR) before it reaches the brain. The clearance was based on data from the pivotal SENTINEL
Devices
FDA has approved an expanded indication for Edwards Lifesciences’ Sapien 3 Transcatheter Heart Valve for patients with symptomatic heart disease due to failure of a previously placed bioprosthetic aortic or mitral valve whose risk of death or severe complications from repeat surgery is high. “For the first time, a regulatory
Devices
FDA has approved Inspire Medical Systems’ next generation Inspire 3028 implantable pulse generator for treating obstructive sleep apnea (OSA). The implantable device’s approval also covers magnetic resonance imaging conditional labeling to allow patients to undergo such testing. The Inspire 3028 is 40% smaller and 18% thinner than the current
Drugs
Public Citizen and 12 other patient advocacy groups are urging House Energy and Commerce Committee members to reject two bills that would “undermine regulatory standards for ensuring that drugs and medical devices are safe and effective for each marketed use.” In a 6/5 letter, the groups argue that HR
Devices
CDRH says it intends to extend the compliance dates for the unique device identification (UDI) system requirements for low-risk medical devices (certain Class I and unclassified devices), such as manual surgical instruments and mechanical wheelchairs. The Center and industry have already implemented requirements for higher-risk medical devices (Class
Devices
Abbott has begun a Class 1 recall of its Absorb Bioresorbable Vascular Scaffold system, a temporary scaffold indicated for improving coronary luminal diameter. The company says it is recalling the device after studies showed elevated rates of major adverse events, specifically, myocardial infraction and scaffold thrombosis when compared to patients
Drugs
The HHS Office of Inspector General (OIG) says settlements were reached with a drug company and a durable medical equipment company during the six months ending 3/31. In a semi-annual report to Congress covering the period 10/1/16 to 3/31, the OIG says Shire entered into
Devices
On board for less than a year, CDRH Office of Device Evaluation director John Sheets has left the agency to “pursue other opportunities,” an FDA spokeswoman tells FDA Webview. Center chief scientist Willaim Maisel has assumed acting ODE director duties until a replacement is found. Sheets replaced former director Christy
Devices
FDA has approved a Roche PMA for its Ventana ALK (D5F3) CDx Assay as a companion diagnostic to identify anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) patients eligible for treatment with Novartis’ Zykadia (ceritinib). The agency 5/30 approved the expanded use of Novartis’ Zykadia (ceritinib)
Devices
FDA has cleared an OrthoAccel Technologies 510(k) for its AcceleDent Optima, an orthodontic device that directly connects patients and practices with usage monitoring, direct messaging and virtual rewards via the AcceleDent App, which can be downloaded from iTunes and Google Play. The third generation vibratory accelerated orthodontic device is
Drugs
FDA has denied a Mallinckrodt petition relating to the company’s Inomax without commenting on whether it will do any or all of the actions the company requested. The response lists the company’s petition requests as: * require that all future inhaled nitric oxide drug products and delivery systems be
Devices
FDA says that a 4/17 Zimmer Biomet recall of 33 implantable spinal fusion stimulators is Class 1. The devices were recalled due to the potential of harmful chemicals that may be toxic to tissues and organs, according to an agency recall notice. The stimulator is used during spinal fusion
Devices
Pioneer anti-power morcellator activist Amy Reed, 44, died 5/24 from complications stemming from disseminated uterine cancer, reported the Cancer Letter 5/25. Reed was the wife of cardio thoracic surgeon Hooman Noorchasm, who took up her cause in a virulent multimedia campaign widely reported by the Wall Street