Sequent Medical said today it won clearance from the FDA to add its smaller .021″ Web aneurysm embolization system to its investigational device exemption trial. The smaller .021″ version is the latest generation Web device from the Aliso Viejo, Calif.-based company, delivered through a smaller version of its VIA microcatheter. The Web implant is made of a […]
Food & Drug Administration (FDA)
Osprey rises on FDA 510(k) for DyeVert
Osprey Medical (ASX:OSP) said it received FDA 510(k) clearance for its DyeVert contrast modulation system, sending shares of the company to a nearly 2-month high. The DyeVert system automates contrast modulation during manual dye injections, self adjusting for catheter and contrast types without requiring user adjustments, Osprey said. “With FDA Clearance of our DyeVert System, […]
FDA clears Endologix’ AFX2 bifurcated stent graft
Endologix (NSDQ:ELGX) said it won FDA premarket approval for its AFX2 bifurcated endograft system for treating abdominal aortic aneurysms. The system is the newest-generation of AFX endovascular AAA product from the Irvine, Calif.-based company. The new version of the device reduces delivery and deployment procedure steps and can facilitate percutaneous endovascular aneurysm repair through a low-profile […]
NuVasive wins FDA nod for X-Core cervical corpectomy cage
NuVasive Inc. (NSDQ:NUVA) said today that it won 510(k) clearance from the FDA for its X-Core mini cervical corpectomy cage, claiming it as the 1st such device cleared for the U.S. market. The X-Core device is designed to replace vertebrae in the cervical spine (C3 to C7), San Diego-based NuVasive said. It must be used with […]
Sientra halts U.S. sales
Breast implant maker Sientra (NSDQ:SIEN) last week put a temporary hold on U.S. sales of implants made by Brazilian contract manufacturer Silimed, sending its shares down 11% in after-hours trading. Brazilian regulator Anvisa and the U.K.’s Medicines & Healthcare Products Regulatory Agency had already suspended sales of implants made by Silimed, which is Sientra’s sole supplier, after contamination was detected during an audit of […]
Cook expands Class I Beacon Tip recall
Cook Medical said today it expanded its recall of its Beacon Tip angiographic catheters to include all lots of select sizes of the catheters. The recall is based on 42 medical device reports of the tips splitting or separating, which leads to loss of device function and can require medical intervention or face the potential of […]
FDA clears CareStream’s Vue Motion on desktop, tablets
CareStream Health said yesterday it won FDA 510(k) clearance for its Vue Motion universal viewer system designed for the diagnostic viewing of electrocardiogram waveforms. The system is designed for clinicians, physicians and cardiologists to view ECG exams for patients with ST segment elevation myocardial infarction and other heart conditions and illnesses, the Rochester, N.Y.-based company […]
Watchdog OSC backs FDA over whistleblower
The U.S. Office of Special Counsel last month backed up the FDA’s review of disputed device approvals brought about by an anonymous whistleblower. The whistleblower alleged that FDA employees handling review and approval of medical devices “violated agency regulations” and created “substantial and specific danger to public health and safety” by approving colonography devices for general […]
Sanders to oppose Califf as FDA chief
(Reuters) — Sen. Bernie Sanders (I-Vt.), who is seeking the Democratic presidential nomination, said today he will vote against Dr. Robert Califf as the next FDA commissioner, citing the nominee’s close ties to the pharmaceutical industry. “Instead of listening to the demands of the pharmaceutical industry and their 1,400 lobbyists, it is about time that the FDA and […]
StimGuard wins another IDE nod for bladder treatment trial
StimGuard said it won another FDA Investigational Device Exemption to run a clinical trial of its percutaneously implantable device to treat urgency urinary incontinence as a result of refractory overactive bladder syndrome. The StimGuard device utilizes a 1.3mm microchip neurostimulator designed to be implanted non-surgically with a needle. The stimulator communicates with a small external […]
FDA clears Medtronic’s Tyrx envelope for DBS devices
Medtronic (NYSE:MDT) said today that it’s launching its Tyrx surgical envelope in the U.S. for use with deep-brain stimulation devices, after it won 510(k) clearance from the FDA for use of the infection-fighting envelope with implantable neurostimulators. Fridley, Minn.-based Medtronic said it’s planning to make the Tyrx device, acquired for $160 million in January 2014, available for […]