Medtronic (NYSE:MDT) said today it won expanded FDA approval for its Pipeline Flex embolization device. The device is now indicated for patients with small or medium, wide-necked brain aneurysms in the territory from the petrous to the terminus of the internal carotid artery, the Fridley, Minn.-based company said. The Pipeline Flex was previously cleared for the […]
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
FDA publishes finalized guidance for buprenorphine depots
The FDA this week published a finalized guidance document for companies developing new buprenorphine depot products for the treatment of opioid use disorder. The agency is hoping to boost the development of modified-release buprenorphine products, like drug-eluting implants. In the document, the FDA detailed the studies needed to support approval for these products through the 505(b)(2) pathway. Get […]
Safety board OKs continuation of CytoSorbents endocarditis trial
CytoSorbents (OTC:CTSO) said this week it the Data Safety Monitoring Board of its REMOVE trial gave the company the green light to continue the study after analyzing data from the first 50 patients. The German gov’t-funded randomized, controlled, multi-center 250-patient REMOVE trial, which was launched in late 2017, looked to explore the safety and efficacy of […]
FDA clears Current Health’s patient monitoring system
Wearable medical device developer Current Health said today it won FDA clearance for its its wireless wearable patient monitor. The Edinburgh, Scotland-based company’s wearable monitor tracks vital signs and is intended to provide extra information to clinicians to allow for earlier interventions. Current touted the device as “the most accurate, all-in-one wireless wearable currently approved […]
Flowonix wins FDA nod for infusion pump software
Flowonix Medical said yesterday that it won FDA approval to market the updated software used to program the company’s Prometra infusion system. The clinician programmer software, which Flowonix plans to launch in February, includes automatic calculations and increased dosing flexibility during bridge bolusing, according to the company. Get the full story at our sister site, Drug […]
FDA doubles down on warfarin test strip recall
The FDA this week alerted patients and doctors about test strips used to monitor levels of the blood thinner warfarin, expanding and reiterating its warning that the products shouldn’t be used to adjust a person’s drug dosage. The agency’s latest notice is related to the Class I recall of Roche‘s CoaguChek meters and test strips, which […]
J&J’s Biosense Webster launches IDE-cleared Qdot Micro RF ablation trial
Johnson & Johnson‘s (NYSE:JNJ) Biosense Webster said yesterday it launched a new FDA investigational device exemption study of its Qdot Micro radiofrequency ablation catheter exploring its use in treating symptomatic drug-refractory paroxysmal atrial fibrillation. The first patient in the trial has already been treated, with the procedure taking place at NYU Langone Health’s Heart Rhythm Center, the […]
Teleflex wins FDA PMA for Manta large bore vascular closure device
Teleflex (NYSE:TFX) said today that it won FDA premarket approval for its Manta vascular closure device, touting it as the first such device specifically designed for large bore femoral access site closures. The newly cleared Manta device won indications for closing femoral arterial access sites while reducing time to hemostasis following the use of 10-20F devices […]
FDA: Interim data from post-market Abiomed Impella RP study shows 17% survival rate
The FDA yesterday said that interim data from a post-approval study of Abiomed‘s (NSDQ:ABMD) Impella RP heart pump system showed only a 17.4% survival rate, approximately 55% lower than the rate noted in the premarket study of the device. The federal watchdog said that it is currently evaluating data from the study and that it will […]
Oxipit wins CE Mark for AI-powered chest imaging suite
Medical imaging tech dev Oxipit said today that it won CE Mark approval in the European Union for its ChestEye radiology imaging suite. The ChestEye system is designed to provide analysis and preliminary reports for 75 of the most common radiological findings, Oxipit said. The system localizes its findings on a radiograph as a heatmap […]
Cook Medical wins FDA nod for Zenith aortic dissection repair stent
Cook Medical said today that it won FDA approval for its Zenith Dissection endovascular system intended to treat Type B aortic dissections. The Bloomington, Ind.-based company’s newly cleared system consists of a proximal stent-graft component and bare stent distal component and is intended to prove a less invasive alternative to open surgery for repairing Type B […]