Medtech developer Concept Medical said today it won FDA breakthrough device designation for below-the-knee (BTK) use of its MagicTouch sirolimus drug-coated balloon catheter designed for the treatment of peripheral artery disease. The Tampa, Fla.-based company won the same designation for MagicTouch for the treatment of coronary in-stent restenosis in April. The XTOSI clinical study at Sengkang […]
FDA wants more study of paclitaxel-eluting devices’ long-term safety
The FDA said yesterday that it wants more long-term safety and effectiveness studies done on paclitaxel-eluting stents and balloons, and urged physicians to carefully consider when to use them. In a letter to healthcare providers, the agency recommended discussing the risks and benefits of the devices with patients and continue “diligent monitoring” of patients who […]
B. Braun wins breakthrough nod for drug-coated balloon catheter
The FDA has granted B. Braun Interventional Systems breakthrough device designation for the company’s SeQuent Please ReX drug-coated percutaneous transluminal coronary angioplasty (PTCA) balloon catheter for the treatment of coronary in-stent restenosis (ISR). The designation follows 10 years of clinical studies on the SeQuent Please drug-coated PTCA catheters, with data reported in peer-reviewed articles, according to the […]
FDA issues new postmarket guidance for drug-device products
The FDA has released final postmarket guidance for manufacturers of drug-device combination products. The guidance outlines how the agency expects manufacturers of combination products and those that make constituent parts of drug-device combinations to report adverse events and product malfunctions. Combination-product manufacturers will have five working days to report adverse events that require remedial action […]
BD updates infusion pump recalls
Becton Dickinson (NYSE:BDX) said today it has updated two voluntary recalls of certain Alaris infusion pump modules and infusion sets used with those modules. The FDA has designated both recalls as Class I, as the agency has received reports of several serious injuries associated with the recalled devices. The Alaris model 8100 modules were manufactured […]
Ocular Therapeutix gains second indication for drug-delivery eye insert
Ocular Therapeutix (NSDQ:OCUL) said today that the FDA has approved a supplemental NDA for its dexamethasone ocular insert, Dextenza. The Bedford, Mass.-based company requested in January that the U.S. regulatory agency expand the current indication for Dextenza to include the treatment of ocular inflammation following eye surgery. Dextenza is designed to deliver drugs for up […]
Abbott touts real-world CGM data at diabetes conference
Abbott (NYSE:ABT) said today that new data show its FreeStyle Libre continuous glucose monitoring (CGM) system significantly reduces hemoglobin A1c (HbA1c) levels in certain adults with type 2 diabetes. Presented as a late-breaker at American Diabetes Association (ADA) annual conference in San Francisco, the data represent what Abbott termed the first evaluation of real-world evidence from […]
U.K. says doctors should limit use of paclitaxel devices
U.K. medtech regulators have recommended a ban on routine use of paclitaxel drug-coated balloons (DCBs) and drug-eluting stents in patients with intermittent leg cramps, but held back on recommending the same for patients with critical limb ischemia. U.S., U.K. and French regulators began raising concerns about the risk of increased long-term mortality in people with […]
Phillips-Medisize Arkansas plant expands medtech capacity
Phillips-Medisize said today that it now has FDA-compliant manufacturing space in the Little Rock, Ark. plant of its parent company, Molex. The 380,000-square-foot facility is now fully compliant with the Current Good Manufacturing Practice (CGMP) regulations (21 CFR part 820) enforced by the FDA. The plant can now be used for Phillips-Medisize’s medical manufacturing services, including […]
FDA nixes Evoke Pharma’s gastro nasal spray
The FDA has rejected Evoke Pharma’s (NSDQ:EVOK) application for a metoclopramide nasal spray for diabetic women with gastroparesis. The Solana Beach, Calif. company’s stock price tumbled 40% on the news yesterday that the agency had found dosing inconsistencies in the pivotal pharmacokinetic study for the spray, Gimoti. In an earlier multi-disciplinary letter to the company, […]
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