Medtech startup Affluent Medical (Paris, France) said a study of its endovascular aneurysm repair (EVAR) system device showed patients had fewer endoleaks and needed fewer secondary interventions, and that their aneurysms shrank in volume and diameter. The company’s Kardiozis endovascular prosthesis uses thrombogenic fibers to embolize an abdominal aortic aneurism sac during a conventional EVAR procedure […]
Becton Dickinson wins FDA 510(k) for Wavelinq 4F endoAVF system
Becton Dickinson (NYSE:BDX) said today that it won FDA 510(k) clearance for its WavelinQ 4 French endovascular arteriovenous fistula creation system. The Franklin Lakes, N.J.-based company said that the newly cleared WavelinQ 4F endoAVF system features improved technology that allows for the creation of an AVF in either the ulnar artery and ulnar vein or the radial […]
Shockwave Medical registers for $70m IPO
Shockwave Medical has registered for an upcoming initial public offering worth $70 million, according to recently posted SEC filings. The Santa Clara, Calif.-based vascular tech developer is looking to list its common stock on the Nasdaq Global Market under the symbol “SWAV,” according to the filing. Net proceeds from the offering are slated to support […]
HeartFlow publishes findings from consumer survey
HeartFlow this week published the findings of a 1,500-person consumer survey, reporting that just 29% of respondents knew that heart disease is the No. 1 cause of death among adults in the U.S. Half of the survey’s participants said that breast cancer is the leading cause of death among women, rather than heart disease. “We […]
FDA expands indications for Medtronic’s Pipeline Flex embolization device
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 […]
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 […]
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 […]
Reva Medical cuts 44% of workforce
Reva Medical (ASX:RVA) said this week that it plans to cut its workforce by 44%, leaving 22 employees at the San Deigo-based company. In a statement, Reva CEO Reggie Groves cited current market conditions as the primary reason for the staffing reduction. Get the full story at our sister site, Drug Delivery Business News.
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 […]
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 […]
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