The FDA recently labeled a select recall of West Pharmaceutical Services‘ (NYSE:WST) Vial2Bag fluid transfer systems over device functionality issues as Class I. Class I designations, the FDA’s most severe, are used when there is a reasonable probability that product use could cause serious adverse health consequences of death. The West Whiteland Township, Penn.-based company’s Vial2Bag […]
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
Ascyrus Medical wins CE Mark for aortic dissection stent
Ascyrus Medical said today that it won CE Mark approval in the European Union for its Ascyrus Medical Dissection Stent, or AMDS, intended for treating acute type A aortic dissections. The Boca Raton, Fla.-based company’s AMDS is an arch remodeling hybrid graft designed as an adjunct to surgical reconstruction, and is intended to reduce the […]
FDA labels Edwards Lifesciences’ recall of Swan Ganz thermodilution caths as Class I
The FDA has labeled a select recall of Edwards Lifesciences‘ (NYSE:EW) Swan-Ganz Thermodilution catheters over issues with the lumen assembly as Class I. Class I designations, the FDA’s most severe, are used when there is a reasonable probability that product use could cause serious adverse health consequences or death. The Irvine, Calif.-based company’s Swan-Ganz Thermodilution catheters function […]
Stryker recalls select Lifepak 15 defibs on lock-up issues
Stryker (NYSE:SYK) said last Friday that it is launching a select voluntary recall of Lifepak 15 monitor/defibrillators over issues in which the device locks up and may not deliver life-saving therapy, adding that it has received six reports of deaths related to the issue. The Kalamazoo, Mich.-based company said that an issue with the Lifepak 15 […]
FDA rejects Alkermes depression drug NDA
Alkermes (NSDQ:ALKS) said last Friday that the FDA rejected the company’s new drug application for its ALKS 5461 drug intended to treat patients with major depressive disorder. The Dublin, Ireland-based company’s ALKS 5461 once-daily oral medication is a fixed dose combination of buprenorphine and samidorphan, designed for patients with MDD for whom standard antidepressant therapies have […]
Sirakoss wins CE Mark for Osteo3 bone graft substitute
Sirakoss said yesterday that it won CE Mark clearance in the European Union for its Osteo3 novel nanosynthetic bone graft substitute. The Aberdeen, Scotland-based company said that its Osteo3 consists of an inorganic matrix intended to be completely reabsorbed into the bone. Sirakoss added that the newly cleared bone graft substitute features a unique surface […]
FDA warns on air embolism risk with infusion pumps, fluid warmers, rapid infusers
The FDA today released a medical device safety communication warning of air-in-line and air embolism risks, as well as the risks of false alarms for such events, associated with infusion pumps, fluid warmers and rapid infusers. The FDA reinforced the dangers of air-in-line issues, which can lead to potentially life-threatening air embolisms, but also warned […]
FDA green-lights Siemens Healthineers Magentom Lumina 3T MRI
Siemens Healthineers has received FDA clearance for its Magnetom Lumina 3 Tesla MRI scanner. The scanner features BioMatrix patient personalization that helps improve productivity and ensure consistent quality, according to the company. It has a wide, 70 cm bore and GO technologies that are powered by artificial intelligence to speed up MRI workflow. Magnetom Lumina […]
FDA sets March dates for microbiology, neurology device panel meetings
The FDA this week set two new March dates for public medical device advisory committee meetings, the first to discuss microbiology devices and the second to discuss a specific neurological device, according to official FDA releases. In the microbiology devices panel meeting, slated to be held March 8, a committee of microbiology device experts will […]
Mylan wins race for generic Advair approval
FDA has approved the first generic of GlaxoSmithKline‘s (NYSE:GSK) blockbuster Advair respiratory drug, this one by Mylan (NSDQ:MYL), six months after rejecting Mylan’s application. Canonsburg, PA-based Mylan’s shares jumped 7% to $30.82 at market close after yesterday’s late-afternoon announcement, and were trading at $30.96 mid-morning today. GSK’s stock dipped 2% to$38.70 on the news late yesterday, but had more than […]
Abiomed touts CE Mark for Impella Connect, posts Street-beating FY2019 Q3 earnings
Abiomed (NSDQ:ABMD) said today that it won CE Mark approval in the European Union for its Impella Connect cloud-based Impella heart pump console and released fiscal year 2019 third quarter earnings that topped expectations on Wall Street. The Danvers, Mass.-based company said its Impella Connect is a cloud-based platform that allows physicians and hospital staff to […]