Devices
FDA has cleared a Roche 510(k) for the cobas TV/MG test for use on the cobas 6800/8800 Systems for detecting Trichomonas vaginalis (TV) and Mycoplasma genitalium (MG) DNA in both symptomatic and asymptomatic patients. The expanded clearance now permits laboratories to simultaneously process from a single patient
Drugs
The Office of Management and Budget Spring 2019 Rule List includes 80 proposed and final stage rules from FDA. The HHS listing includes 61 regulations in the proposed rule stage for FDA-regulated products, and 19 at the final rule stage.
Devices
Johnson & Johnson says that an FDA proposal to post a list of devices relying on predicates older than a specified number of years is “built on a lack of evidence that age of predicate is a substantial indicator of medical device innovation.” Commenting on agency proposals to modernize the
Devices
FDA says it is looking for test cases from software organizations planning to submit a de novo request or 510(k) submission for software as a medical device to meet the goals of the software precertification program. An agency notice says volunteers are sought representing a broad spectrum of software
Devices
Four Democratic representatives have introduced the Medical Device Guardians Act to put into law an existing mandate of the American Medical Association’s Code of Medical Ethics recognizing that doctors are in the best position to identify and report unsafe medical devices. The bill also would add doctors’ reports to
Devices
Exeed, a medical device consulting firm, says FDA is changing the way it interacts with violative medical device firms to evaluate and help them develop an appropriate plan of corrective action. In a blog post, Exeed says that the agency’s subtle change in its use of Warning Letters is
Devices
An 11/6-11/9/18 FDA inspection at Zeller Power Products’ medical device operations in Las Vegas, NV, found Quality System Regulation and other violations in the firm’s manufacturing of Class 3 automated external defibrillator batteries intended to replace the original equipment manufacturer battery used in Cardiac Science
Devices
A 2/4-2/15 FDA inspection at Orchid Orthopedic Solutions, Farmington Hills, MI, found Quality System Regulation violations in the firm’s work as a medical device manufacturer specializing in applying coatings to orthopedic implants that promote bone ingrowth. A 5/13 Warning Letter says the specific violations were:
Devices
FDA has cleared a Body Vision Medical 510(k) for the LungVision 2.0 System. The new device features “real-time tool-in-lesion confirmation combined with seamless integration of LungVision Tool, a disposable lung navigation catheter,” according to the company. The LungVision Tool, which is guided by the LungVision
Devices
A revised safety update on Abiomed's Impella RP System emphasizes proper patient selection after interim post-approval study (PAS) results indicated a lower survival rate for the subgroup of PAS patients who would not have qualified for inclusion in clinical studies performed before the device was approved. The
Devices
For a decade, Medtronic was allowed by FDA to report thousands of adverse events associated with the company’s Sprint Fidelis defibrillator under a publicly-shielded “alternative summary reporting” program, according to a Kaiser Health News (KHN) report posted on CNN.com. Faced with criticism, FDA has ceased the alternative
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 Qiagen 510(k) for the multiplex QIAstat-Dx Respiratory Panel for simultaneous qualitative detection and identification of multiple respiratory viral and bacterial pathogens. The next-generation multiplex molecular diagnostic system, which is based on the company’s proprietary DiagCore technology, can detect more than 20 pathogens.
Devices
FDA has issued a safety alert warning patients and health care professionals about risks associated with using unapproved or unauthorized devices for diabetes management, including continuous glucose monitoring systems, insulin pumps and automated insulin dosing systems. The alert notes that the use of unapproved or unauthorized devices could result in
Devices
FDA has cleared a Flat Medical 510(k) for its EpiFaith syringe to deliver safe epidural locating solution. Compared with traditional practice that relies on a manual sense, EpiFaith provides an “intuitive signal” that alerts anesthesiologists when it has arrived in the epidural space, according to the company. The device
Devices
The Justice Department and CDRH director Jeffrey Shuren say Carefusion Corp., San Diego, CA, will pay $3.3 million to the federal government to resolve charges that it bought and sold medical devices that were not cleared or approved by FDA. A Justice Department statement says the unapproved devices were
Drugs
Three researchers say effort needs to be increased to incorporate patient-reported outcomes (PROs) as a data source for real-world evidence. Writing online in the journal Nature Reviews Drug Discovery, the researchers say that as pressures from legislation, international regulatory authorities, and patient groups promote more patient-centric drug
Devices
Ethicon has recalled its Endo-Surgery Curved Intraluminal Stapler with Adjustable Height Staples and Endo-Surgery Endoscopic Curved Intraluminal Stapler with Adjustable Height Staples due to insufficient firing, which can compromise staple line integrity. According to a recall notice, surgeons use the devices in the “gastrointestinal tract for creating connections
Devices
FDA has cleared a Masimo 510(k) for the Radius PPG, a tetherless sensor associated with the Masimo SET patient monitor. The sensor eliminates the need for a cabled connection to a pulse oximetry monitor, allowing patients to move freely while still being continuously monitored. Through a wireless connection, measurements
Devices
FDA has cleared a GenePOC 510(k) for the Carba assay and its use with the Revogene device to detect carbapenem-producing organisms (CPO). CPOs are known to be resistant to commonly used antibiotics and occasionally completely resistant to all available antibiotics, the compamy says. The qualitative, in vitro diagnostic
Devices
Commenting on an FDA request for comments on modernizing the 510(k) program, AdvaMed says it supports the current program, which includes the ability to use older legally marketed devices as predicates, to the extent substantial equivalence can be demonstrated. “The 510(k) program has demonstrated its effectiveness and durability
Devices
FDA has approved a W. L. Gore PMA for the Gore Tag Conformable Thoracic Stent Graft with Active Control System, an endovascular aortic repair device. The device and delivery system is designed to provide new precision and predictable patient outcomes in the endovascular repair of aneurysms, transections, and Type B