LivaNova (NSDQ:LIVN) said today that its vagus nerve stimulation therapy for treatment-resistant depression has won the CE Mark in Europe. Two patients in the United Kingdom were implanted with the company’s Symmetry system at the Musgrove Park Hospital in Taunton, England, making them the first patients to receive Symmetry devices outside the United States. The ability […]
J&J’s Ethicon wins lawsuit over hernia mesh
A New Jersey appeals court has thrown out a lawsuit against Johnson & Johnson (NYSE:JNJ) and its Ethicon unit because the woman who had mesh implanted to correct a hernia could not identify its manufacturer. Plaintiffs Deborah Kline and her husband, Jeffrey Derstine, sued the companies in 2014, alleging that the polypropylene mesh implanted in Kline’s […]
Pavmed to resubmit carpal tunnel device 510(k) application
Pavmed (NSDQ:PAVM) said today that it has reapplied for FDA 510(k) clearance for its CarpX device designed to treat carpal tunnel syndrome. In August 2018, the FDA group reviewing the application for CarpX requested that the company resubmit the application because the group hadn’t reached a consensus within the designated review period. The resubmission incorporates data […]
Feds implicate spinal device company in $8m kickback scheme
The U.S. Attorney’s Office is suing a Massachusetts spinal device company and an associated consulting firm alleging they paid $8 million in kickbacks to induce surgeons to use the device company’s products. The lawsuit names SpineFrontier (Malden, Mass.) and consulting firm Impartial Medical Experts (IME) as well as executives of both companies in the alleged […]
FDA seeks comment on next round of user fees
The FDA has scheduled a public meeting for April 7 to discuss the the medical device user fee program that will be in place from 2022 to 2026. The current Medical Device User Fee Amendment (MDUFA IV) expires Sept. 30, 2022. Before Congress can reauthorize the amendment, the FDA must consult with the regulated industry […]
V-Wave lands CE Mark for heart-failure device
V-Wave announced today that its Ventura interatrial shunt system has received the CE Mark. The Caesarea, Israel-based company’s minimally invasive, implanted interatrial shunt is being evaluated in a global, randomized, controlled, double-blinded, 500-patient pivotal IDE trial called RELIEVE-HF. The study is enrolling advanced heart failure patients with preserved or reduced left ventricular ejection fraction who […]
Align Technology to acquire software maker Exocad
Align Technology (NSDQ:ALGN) announced it has agreed to acquire dental software company Exocad (Darmstadt, Germany) for approximately $420 million in cash. The move will add Exocad’s experience in restorative dentistry, implantology, guided surgery and design to Align’s technology portfolio, which includes Invisalign clear-aligner orthodontic and iTero digital solutions. Exocad will also bring nearly 200 digital dentistry […]
NeuroMetrix settles $4m false advertising case with FTC
Pain-treating TENS device company NeuroMetrix (NSDQ:NURO) has agreed to pay at least $4 million to settle a false advertising case brought by the Federal Trade Commission FTC. The commission said today that the Woburn, Mass.-based company also agreed to stop making deceptive claims that its Quell device treats pain throughout the body when placed below the […]
Boston Scientific settles Canadian pelvic mesh case for $21.5m
Boston Scientific (NYSE:BSX) has agreed to settle a transvaginal mesh class action lawsuit brought by women in Canada for $21.5 million, according to a report by the Canadian Press. The proposed settlement involves about 325 women whose share of the money would depend on the severity of their medical issues, the news service reported. Final approval […]
FDA bans electroshock behavior-control devices
The FDA has banned electrical stimulation devices sometimes used to treat self-harm and aggression in people with intellectual or developmental disabilities. The agency, which rarely bans medical devices, proposed the ban on the devices in 2016 because they present “an unreasonable and substantial risk of illness or injury to the public.” Some people’s intellectual or developmental […]
Report: FDA promise of 1 million coronavirus tests this week unattainable
The FDA grossly overestimated the number of coronavirus diagnostic tests that would be available this week as well as U.S. laboratories’ capacity to process them, according to a report in the New York Times. FDA commissioner Stephen Hahn told reporters on Monday that the agency’s decision allowing private labs to make their own tests would […]