Devices
FDA has updated its Essure Web page with information on medical device reports about Essure received in 2018. The agency says it continues to post the latest information about Bayer’s postmarket surveillance study on the 522 study Web page. The company withdrew Essure from the market at the end
Devices
Senate HELP Committee ranking member Sen. Patty Murray (D-WA) says data recently released by FDA shows “alarmingly high rates of contamination in certain duodenoscopes, even after the device is cleaned.” In a 5/9 letter to OIympus, she says the data “raise serious questions about your company’s ability
Devices
FDA has cleared an eMurmur 510(k) for the eMurmur ID Solution for detecting heart murmurs. The company says the mobile and cloud device operates in conjunction with a third-party electronic stethoscope. The device is a mobile and cloud solution that analyzes heart sounds to identify innocent and pathological
Devices
Akin Gump attorneys say several recent FDA actions indicate a change in the agency’s enforcement discretion policy for laboratory-developed tests (LDTs). Writing in an online post, the attorneys say the agency recently issued a Warning Letter to a laboratory advising it to seek marketing authorization for its genetic
Devices
FDA has cleared a Haemonetics 510(k) to expand the medical indication of its TEG 6s Hemostasis Analyzer System for use in adult trauma settings. This clearance builds on the current indication for the TEG 6s system in cardiovascular surgery and cardiology procedures. Clearance was based on clinical data from
Drugs
In a unanimous decision, the Supreme Court has said that whistleblowers will have up to four years of additional time to file False Claims Act (FCA) suits against healthcare and other firms. The justices said that FCA claimants can sue up to three years after the responsible federal official knew
Devices
FDA has approved Abiomed’s expanded use of its Impella 5.0 and Impella LD heart pumps for treating cardiogenic shock. The expansion extends the duration of support for each pump from six days to 14 days. The forward flow heart pumps are intended for stabilizing a patient’s hemodynamics,
Devices
FDA has cleared a Zebra Medical Vision 510(k) for the HealthPNX, an artificial intelligence (AI) alert for pneumothorax, based on chest x-rays. Pneumothorax is a condition in which there is an accumulation of gas within the pleural space between the lung and the chest wall. Without prompt attention,
Devices
Reps Rosa DeLauro (D-CT), Jan Schakowsky (D-IL), and Brian Fitzpatrick (R-PA) have reintroduced the Medical Device Safety Act, a bill to increase access to legal recourse for victims of unsafe devices. The bill comes on the heels of a New York Times editorial on changes FDA should
Devices
FDA has granted de novo marketing clearance to KCI for Prevena Incision Management System, a negative pressure medical device indicated to aid in reducing superficial surgical site infections in patients at a high risk for post-operative infections in Class 1 and 2 wounds. The device is also intended to
Devices
FDA has granted Farapulse a breakthrough device designation for its Farapulse Pulsed Field Ablation System and its use in treating drug-refractory, recurrent, symptomatic paroxysmal atrial fibrillation. The device uses non-thermal energy to create durable lesions to improve the safety profile of cardiac ablation. It is intended to offer
Drugs
A Supreme Court decision expected in June could lead to an increase in False Claims Act cases according to some attorneys contacted by Bloomberg Law. The report says that defense attorneys “resoundingly believe [the ruling] will give whistleblowers more time to act on behalf of the government and sue companies
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) is asking FDA to clarify a draft guidance on principles of premarket pathways for combination products. The association says that while it appreciates the agency’s efforts to clarify the premarket pathways for combination products and implement provisions of the 21st Century Cures
Devices
Johnson & Johnson’s DePuy unit has agreed to pay about $1 billion total to resolve most of the lawsuits claiming the company sold defective metal-on-metal hip implants that ultimately had to be removed. Bloomberg Technology reported the agreement would resolve more than 95% of the 6,000
Devices
FDA has cleared two CryoConcepts 510(k)s for cryosurgical devices for physicians. The CryoTouch is a portable device that delivers cryogen to lesion sites and can use either applicators or cones based on a physician’s preference. The CryoLab is a benchtop unit that delivers cryogen for medical practices
Devices
FDA has cleared a BioCardia 510(k) for the Avance steerable introducer, which is designed for introducing various cardiovascular catheters into the heart, including via the left side of the heart through the interatrial septum. The company says the device is “virtually whipless around curves due to their helically arranged
Devices
FDA has already approved so-called “locked” medical devices that rely on artificial intelligence, and now is trying to determine how to certify devices that learn and evolve. Roll Call reports the agency is weighing how to assess and certify devices powered by artificial intelligence that continuously adapt to new
Drugs
Pharmaceutical recalls decreased 7.8% to 94 in the first quarter of 2019, higher than 19 of the last 21 quarters, according to the Stericycle 2019 Q1 index. The report says that recalled units decreased 75.3% to just under 13 million, lower than six of the last nine quarters.
Devices
FDA has issued a final guidance, Utilizing Animal Studies to Evaluate Organ Preservation Devices, to provide recommendations on best practices for using animal studies to evaluate organ preservation devices. The document says the agency recommends balancing the ethical principles of replacement, reduction, and refinement as well as regulatory least burdensome
Devices
FDA has issued a safety alert on certain Medtronic implantable pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) about issues that may cause their batteries in to drain more quickly than expected without warning patients or health care providers. The agency says it has received three medical device reports in
Devices
Recros Medica has filed a de novo regulatory submission for the Nuvellus Focal Contouring System. The device uses the company’s “Rotational Fractional Resection” technology to provide medical aesthetic physicians a single treatment option to improve submental (neck and jowl) contouring. “Nuvellus is a novel alternative to current skin contouring
Devices
FDA has cleared a Rapid Medical 510(k) for its Comaneci Temporary Coil Embolization Assist Device. The company describes it as the first adjustable, fully-visible aneurysm remodeling device. It is intended to act as a temporary bridge used to aid in the coiling processes while minimizing the risk of