Haemonetics (NYSE:HAE) announced that it acquired next-generation whole blood coagulation testing system developer Enicor GmbH for an undisclosed amount. Munich, Germany-based Enicor develops the ClotPro system designed for viscoelastic diagnostics touted to offer more assays than any other hemostasis analyzer on the market. Haemonetics said in a news release that ClotPro is set to be coupled […]
Medtronic’s Pipeline Flex recall is Class I
The FDA has labeled a recall for the Medtronic (NYSE:MDT) Pipeline Flex embolization device and Pipeline Flex embolization device with Shield technology as Class I. Medtronic wrote to customers risk of device fracture in February and later issued an urgent field safety notice to warn on specific production lots. The affected Pipeline Flex devices are available […]
CMS recommends postponing most elective procedures
The Centers for Medicare and Medicaid Services (CMS) released guidance late yesterday asking healthcare providers to postpone adult elective surgeries and procedures, including dental procedures, until further notice. The move is an attempt to preserve the supply of ventilators and personal protective equipment such as masks and gowns while protecting patients and staff from exposure […]
Abbott wins CE Mark for FlexNav delivery system
Abbott (NYSE:ABT) announced today that it won CE Mark approval in Europe for the FlexNav delivery system for its Portico transcatheter aortic valve implantation (TAVI) system. The Abbott Park, Ill.-based company’s FlexNav delivery system is designed to offer another tool for doctors to treat patients requiring a transcatheter aortic valve implant by incorporating stability, predictability and […]
NYSE accepts Ra Medical’s compliance plan
Ra Medical Systems (NYSE:RMED) announced today that the New York Stock Exchange (NYSE) accepted its business plan to regain compliance with the NYSE continued listing standards. In December 2019, Carlsbad, Calif.-based Ra Medical Systems received a letter from the NYSE to notify the company of its non-compliance with the NYSE continued listing standards, as Ra Medical’s […]
Neovasc to seek CE Mark for Tiara transapical mitral valve repair device
Neovasc (NSDQ:NVCN) announced that it plans to win CE Mark approval for its TA Tiara under the new European Medical Device Regulation (EU MDR) by 2021 or earlier. The company said it has treated 82 patients to date with the transapical (TA) Tiara mitral valve repair device. After reviewing the clinical data from its Tiara I […]
Medtronic issues urgent field safety notice for some Pipeline Flex embolization devices
Medtronic (NYSE:MDT) issued an urgent field safety notice to warn on specific production lots of its Pipeline Flex embolization devices due to the potential for device fracture. The medtech giant initiated verbal communication about the issue last month after identifying the potential for device fracture at the distal section during use, due to a weakened bond […]
Aria completes $31m Series B for its pulmonary hypertension treatment device
Pulmonary arterial hypertension (PAH) treatment developer Aria CV announced today that it completed a $31 million Series B financing round. The proceeds from the round, led by private equity and venture investor Xeraya Capital, are earmarked for funding St. Paul, Minn.–based Aria CV’s first U.S. clinical study. Aria CV’s early feasibility investigational study is set […]
Fist Assist announces CE Mark and European launch
Fist Assist Devices recently announced that it received CE Mark approval for its Fist Assist device for vein enhancement and enlargement. Los Altos Hills, Calif.-based Fist Assist Devices said it has begun commercialization and marketing of the device in the European Union. The Fist Assist device is a non-invasive external platform designed to utilize a […]
Ablative Solutions touts study of its infusion catheter for renal denervation
Ablative Solutions announced today that it received positive results at six months from its post-market study for the Peregrine System infusion catheter, which accomplishes renal denervation by delivering microdoses of dehydrated alcohol. The results from the study of the safety and efficacy of the CE-Marked Peregrine System have been published in the Journal of the […]
Bluegrass Vascular Technologies wins de novo nod for ‘inside-out’ vascular access catheter
Bluegrass Vascular Technologies announced that it won FDA de novo clearance for its Surfacer inside-out access catheter system. The Surfacer is designed to obtain central venous access through its inside-out approach, facilitating catheter insertion to the central venous system in people with upper body venous occlusions or other conditions that limit central venous access through […]
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