Devices
In a 4/29 Washington Legal Foundations Legal Backgrounder, attorneys from King & Spalding examine the recent U.S. v Vascular Solutions acquittal and analyze the government’s shift in strategy as the courts come to terms on the importance of First Amendment protections with regar its regulatory and enforcement
Devices
FDA has granted Quest Diagnostics an Emergency Use Authorization for the Zika Virus RNA Qualitative Real-Time RT-PCR test. The proprietary molecular test is intended for the qualitative detection of RNA from the Zika virus in human serum specimens from certain individuals, according to the company. The authorization allows
Devices
Patient group Essure Problems and Ennis & Ennis Law have written Congressman Jason Chaffetz (R-UT) urging a congressional investigation and hearing request over FDA’s approval of Bayer’s Essure contraceptive and alleged injuries caused by the device. Chaffetz is chairman of the House Committee on Oversight and Government
Devices
FDA has cleared an AtriCure 510(k) for its AtriClip PRO2 Left Atrial Appendage (LAA) Exclusion System that is designed for “increased functionality” than its previous model when occluding the LAA during surgical procedures. The device features an “ambidextrous locking and trigger-style clip closing mechanism, handle-based active articulation
Drugs
Attorney Jeffrey Shapiro (Hyman, Phelps & McNamara) says that the current legal/enforcement situation regarding off-label promotion of drugs and medical devices has little to commend it. Writing in an online Update, Shapiro says that the status quo “does not respect the First Amendment rights of device and drug
Devices
The Infectious Disease Society of America, the American Society for Microbiology, and the Pan American Society for Clinical Virology say they are concerned that infectious diseases laboratory developed tests (LDTs), which they say have little evidence of providing unreliable results that lead to harmful patient care decisions, are not being
Devices
At the 3/4 MDUFA 4 reauthorization meeting, industry representatives expressed concern that there was a large gap between an FDA proposal made at the meeting and the proposal that industry presented at an earlier meeting. Minutes from the 3/4 session indicate that the agency’s updated proposal package
Devices
A 10/5-10/8/15 FDA inspection at DMP Ltd., Markopoulo, Greece, which manufactures dental impression materials and composite resins, found multiple Quality System Regulation violations, according to a just-released 3/4 Warning Letter. Specific violations listed on an FDA-483 included: * failing to establish and maintain procedures
Devices
FDA has cleared a Royal Philips 510(k) to market its computed tomography (CT) devices as a lung cancer screening center. The low-dose lung cancer screening indication pertains to the company’s 27 CT and PET/CT models, as well as integrated software and services, it says. To address
Devices
AdvaMed says that FDA should better align its draft guidance on postmarket management of cybersecurity in medical devices with its premarket cybersecurity guidance. A 4/21 comment letter says that the trade group recognizes that combining the guidances “presents some administrative challenges [but] we believe the agency should combine both
Devices
FDA has cleared a Potrero Medical 510(k) for the Accuryn Monitoring System, a diagnostic urinary catheter for patients requiring tight fluid management, including patients at risk of sepsis and acute kidney injury. The device is designed to provide accurate, real-time urine output, intra-abdominal pressure, and temperature measurement,
Devices
FDA has cleared an Exactech 510(k) to market its Vantage Total Ankle to treat patients who suffer from arthritis in the ankle. The device is designed with a curved surface talar component that is engineered to fit the anatomy of the diseased talus and restore the joint line. It
Devices
Rep. Jim Langevin (D-RI), who co-chairs the Congressional Cybersecurity Caucus, is supporting FDA’s draft guidance on “Postmarket Management of Cybersecurity in Medical Devices.” In a 4/21 letter to the agency, Langevin said the guidance, when finalized, should help improve medical device cybersecurity. “The risk-based nature
Devices
In a rare move, FDA has proposed a ban on electrical stimulation devices (ESDs) used for self-injurious or aggressive behavior because they present an unreasonable and substantial risk to public health that can’t be addressed in product labeling. ESDs send electrical shocks through electrodes attached to the skin
Devices
FDA has cleared a Fiagon 510(k) for its brain navigation software, BiopsyPointer FlexPointer 1.5 and the ShuntPointer. The device uses an electromagnetic tracking system to locate surgical instruments during a surgery in relation to a patient’s CT scan. It relies on instruments that have a proprietary “chip
Devices
A Texas federal court jury has ruled that Abbott did not “cause” providers to submit false Medicare payment claims for off-label use of biliary stents as a whistleblower had alleged. Attorney James Holloway (Ober Kaler) writes in an online blog post that it is important for providers to recognize
Devices
FDA’s Orthopedic and Rehabilitation Devices Panel has voted 10 to 2 to recommend approval for a Cartiva PMA for its synthetic cartilage implant for treating degenerative and post-traumatic arthritis in the first metatarsophalangeal joint. The panel based its decision on data from the company’s MOTION study, which
Devices
FDA has cleared a Hologic 510(k) for the Affirm prone biopsy system that offers both 2D and 3D imaging-guided breast biopsies. The device provides a larger field of view than current systems, which allows radiologists to better target lesions found during 3D mammography exams, as well as other
Devices
Nephros, Inc. has submitted a special 510(k) application to FDA for its Endopur ultrafilter designed to provide hemodialysis quality water. The company says the cartridge, offered in 10", 20", 30" and 40" sizes, is intended to be used as an endotoxin filter in a dialysis
Drugs
FDA Office of International Programs China Office director Leigh Verbois says that China Office staff members spent five days touring the Yangtze River Delta region to meet with counterparts and share information. Writing in an FDA Voice blog post, Verbois says that the region is home to a significant number
Devices
FDA has cleared an Oculus Innovative Sciences 510(k) for the Microcyn-based Lasercyn Gel, intended for use for managing post-non-ablative laser therapy procedures, post-microdermabrasion therapy and following superficial chemical peels. Lasercyn may also be used to relieve itch and pain from minor skin irritations, lacerations, abrasions
Devices
FDA says its adverse event data through 12/31/15 show 294 reports of pregnancy loss in patients reporting use of Bayer’s Essure sterilization device. The FDA statement is included in the agency’s response to Rep. Michael Fitzpatrick (R-PA), who has called for the device to be