Advanced NanoTherapies announced today that it received FDA breakthrough device designation for its SirPlux Duo drug-coated balloon (DCB). Los Gatos, California-based Advanced NanoTherapies received the breakthrough nod for the use of the DCB in treating coronary artery disease in vessels less than 3.0mm. The regulatory win comes weeks after two previous breakthrough designations. SirPlux Duo […]
FDA
Recall of Baxter Clearlink due to risk of leaks is Class I
The FDA announced today that the recall of the Clearlink basic solution set with Duovent from Baxter (NYSE:BAX) is Class I, the most serious kind. Clearkink with Duovent is part of a system for administering drugs and solutions to patients. The majority of the sets are used for the delivery of hazardous drugs (chemotherapy). Increased customer reports […]
Edwards wins FDA approval for Pascal Precision transcatheter valve repair system
Edwards Lifesciences (NYSE:EW) announced today that the FDA approved its Pascal Precision system for patients with degenerative mitral regurgitation (DMR). The implant and transcatheter delivery system represent Edwards’ bid to compete with Abbott and its MitraClip in the DMR treatment space. Irvine, California-based Edwards Lifesciences designed its Pascal Precision system for precision transcatheter edge-to-edge repair […]
Conformis wins FDA clearance for Actera hip system
Conformis (Nasdaq:CFMS) announced yesterday that it received FDA 510(k) clearance for its Actera hip system. Billerica, Massachusetts–based Conformis announced the regulatory win after the market closed on Tuesday, Sept. 13. This afternoon (Wednesday, Sept. 14), shares of CFMS are up 8.5% at 29¢ apiece. The company designed Actera with a tri-taper femoral stem, adding to […]
Philip Morris hires two former FDA officials as it pushes ‘smoke-free’ development
Cigarette maker Philip Morris (NYSE:PM) announced today that it appointed two former FDA officials to leadership positions. Dr. Badrul Chowdhury is the company’s new chief life sciences officer for smoke-free products. Dr. Matthew Holman joins as VP of U.S. scientific engagement and regulatory strategy. Both appointments fall in line with the company’s efforts to push […]
Edwards launches Sapien 3 Ultra Resilia heart valve following FDA approval
Edwards Lifesciences (NYSE:EW) announced today that it launched its next-gen Sapien 3 Ultra Resilia transcatheter heart valve. Irvine, California-based Edwards launched the valve following a recent FDA approval. It incorporates the company’s Resilia tissue technology in the transcatheter aortic valve repair (TAVR) device. Resilia, a bovine pericardial tissue treated with anti-calcification technology, serves as the […]
FDA warns of clip lock issue on some Abbott MitraClip heart valves
The FDA alerted healthcare providers about potential malfunctions with the Abbott (NYSE:ABT) MitraClip clip delivery systems. On Sept. 8, Abbott issued an urgent medical device correction. It informed providers of an increased rate of reports of clip lock malfunctions. Users observed malfunctions both before and after clip deployment. The FDA notice said the events appear […]
Attune Medical wins FDA IDE nod to evaluate ensoETM in radiofrequency ablation procedures
Attune Medical announced today that the FDA granted investigational device exemption (IDE) to study the company’s ensoETM. Chicago-based Attune designed ensoETM to reduce esophageal thermal injury during cardiac radiofrequency (RF) ablation procedures. The IMPACT II study is underway in Europe and already enrolled nearly 20 patients. Attune said in a news release that the single-use […]
FDA clears next-generation RhinAer stylus from Aerin Medical
Aerin Medical announced today that it received FDA 510(k) clearance and launched its next-generation RhinAer stylus. Sunnyvale, California-based Aerin designed the system as a non-invasive, temperature-controlled radiofrequency technology. It treats the causes of rhinorrhea (runny nose), post-nasal drip and congestion associated with chronic rhinitis in a single session. The new RhinAer provides physicians with improved […]
FDA clears Medtronic RespArray patient monitor for procedural sedation and medical-surgical units
Medtronic (NYSE:MDT) announced today that it received FDA 510(k) clearance for its RespArray patient monitor. Fridley, Minnesota-based Medtronic designed RespArray for procedural sedation and medical-surgical units. It features Nellcor pulse oximetry and Microstream capnography. RespArray also offers electrocardiogram (ECG), non-invasive blood pressure (NiBP) and temperature monitoring. Algorithms help to detect respiratory compromise early and reduce […]
FDA approves expanded label for Boston Scientific Watchman FLX
Boston Scientific (NYSE:BSX) announced today that the FDA approved expanded labeling for its Watchman FLX LAAC device for stroke prevention. The approval includes labeling with a 45-day dual anti-platelet therapy (DAPT) option for the left atrial appendage closure device (LAAC). DAPT represents an alternative to 45-day oral anticoagulation (OAC) plus aspirin for post-procedural treatment of […]