By Scott Wooldridge Last night’s DeviceTalks: Minnesota event in Minneapolis highlighted the risks and rewards of medical device entrepreneurship, contrasting the arcs of Kips Bay Medical (OTC:KIPS) and Aum Cardiovascular. Kips Bay founder & CEO Manny Villafaña, the medtech legend who started Guidant and St. Jude Medical (NYSE:STJ), told MassDevice.com publisher Brian Johnson that the company’s wind-down was precipitated by a […]
Food & Drug Administration (FDA)
FDA warns Pearson on ADHD device claims
The FDA published a warning letter it sent to NSC Pearson over issues with the company’s Quotient ADHD being marketed as a consumer device to treat ADHD without the proper clearance. Pearson’s system, originally named the OPTAx system, was cleared with indications for use “as a device that provides clinicians with objective measurements of hyperactivity, […]
Advanced Cath. pulls down 2nd 510(k) for Occlusion Perfusion catheter
Advanced Catheter Therapies said today it won a 2nd FDA 510(k) for its Occlusion Perfusion catheter, covering a new range of sizes for the device. The OPC is a multi-lumen balloon catheter designed to occlude vessels for the local delivery of therapeutic agents, the Chattanooga, Tenn.-based company said. “ACT is very excited about this second […]
FDA slams Sironis for running unapproved trial
The FDA slammed Sironis for running an unapproved clinical trial of its LIR closed-loop fluid administration system, saying the Newport Beach, Calif.-based company never sought the proper approvals from the federal safety bureau. In a warning letter dated March 15 and released by the FDA this week, the agency flagged Sironis for serious violations of […]
FDA forms Patient Engagement Committee on medical devices
By Stewart Eisenhart, Emergo Group The U.S. Food and Drug Administration has begun forming a new Patient Engagement Advisory Committee (PEAC) to improve communications with patients and users on various clinical and regulatory issues involving medical devices. According to the FDA’s announcement and accompanyingblog post, the formation of the new committee reflects a trend toward […]
B. Braun wins FDA nod for Infusomat pump
B. Braun Medical said today that it won 510(k) clearance from the FDA for its 2nd-generation, large-volume Infusomat pump for delivery of parenteral fluids, medications, blood and blood products. “Clinicians, including nurses and anesthesiologists, participated in extensive software navigation testing,” marketing, automation & infusion systems vice president Mike Golebiowski said in prepared remarks. “Based on their feedback, we optimized […]
SynCardia updates on artificial heart recall
SynCardia Systems said today that the Class I recall of the driver for some of its total artificial heart devices was due to a single incident in which a patient briefly lost consciousness but suffered no permanent injury. All affected devices were taken off the market 8 days after SynCardia’s initial warning August 6, the Tucson-based company […]
Ceterix Orthopaedics wins FDA 510(k) for NovoStitch Plus
Ceterix Orthopaedics said today it won FDA 510(k) clearance for its NovoStitch Plus meniscal repair system designed for patients with meniscal tearing. The device is a next-generation version of the company’s NovoStitch, designed to treat a variety of different meniscal tears, the Menlo Park, Calif.-based company said. “The main difference is the NovoStitch Plus has […]
Essure complaints spike nearly 1,400% in 3 years
The FDA logged a nearly 1,400% spike in complaints filed over the Essure permanent female sterilization treatment made by Bayer (ETR:BAYN), according to a review released yesterday ahead of an FDA advisory panel meeting this week. Essure, the only approved permanent birth control device in the U.S., is a small metal coil that is placed in the […]
CeloNova wins FDA nod for U.S. stent trial
Interventional cardiology and radiology company CeloNova BioSciences said today it won FDA approval to launch an investigational device exemption trial of its Cobra PzF coronary stent system for treating patients with a high risk of bleeding. The prospective, randomized Cobra-Reduce trial is being led by Dr. Adnan Kastrati and examine the use of the stent during percutaneous […]
AAA IDE study expands, hopes to add Aortica software
Aortica said today that a physician-sponsored investigational device exemption study of abdominal aortic aneurysm-treating endografts gained FDA approval to introduce a new software-planning tool and expand the number of endografts in the study. The trial is designed to assess new technology that could reduce the need for invasive surgeries in patients with aneurysms that are “too […]