Acutus Medical (Nasdaq:AFIB) announced today that it launched an expanded suite of left-heart access products. Following expanded FDA clearance, Acutus launched the suite to now include the AcQCross Qx system for use with the TruSeal and FXD delivery system for the Boston Scientific Watchman left atrial appendage closure device. Carlsbad, California-based Acutus designed the AcQCross […]
Catheters
Endologix reports positive results from percutaneous bypass trial
Endologix announced today that 12-month results from a trial of its Detour system demonstrated a low rate of complications. Irvine, California-based Endologix’s Detour 2 FDA investigational device exemption (IDE) study was designed to evaluate the safety and effectiveness of the Detour system for percutaneous bypass in the treatment of long-segment femoropopliteal disease. Get the full story […]
Ablative Solutions raises $91.4M in Series D financing round
Ablative Solutions today announced it completed the fourth tranche of its Series D financing round and raised $91.4 million. Wakefield, Massachusetts-based Ablative Solutions earmarked the funds to complete the company’s ongoing Target BPI pivotal trial that is evaluating its alcohol-mediated renal denervation procedure. Get the full story on our sister site, Medical Tubing + Extrusion.
Retractable Technologies downsizes workforce
Retractable Technologies this week announced that it has reduced its workforce by 16% due to the completion of its facility expansion efforts — and the completion of U.S. government orders related to COVID-19 vaccines. The staff reduction will affect the Little Elm, Texas-based company’s production, operations and logistics departments. Retractable Technologies said in an SEC […]
What is pulsed-field ablation? Here’s what you need to know
Top experts at Boston Scientific, Medtronic and Acutus Medical shared insights about pulsed-field ablation’s potential at DeviceTalks Boston. Pulsed-field ablation is a non-thermal method for cardiac ablation that has the potential to positively disrupt the way atrial fibrillation is treated. PFA’s roots go back to the dc ablation tech of the 1980s. These days, PFA […]
Getinge’s Atrium Medical has a Class I recall over covered stents
The FDA today determined that Atrium Medical’s recall of some of its iCast covered stents is Class I, the most serious kind. Hudson, N.H.–based Atrium Medical — a subsidiary of Swedish medtech giant Getinge — is recalling certain iCast covered stent systems due to complaints of separation of the balloon or catheter hub from the […]
Cardio Flow’s FreedomFlow guidewire wins FDA clearance
Cardio Flow this week won FDA 510(k) clearance for its FreedomFlow peripheral guidewire and announced the first commercial case using the device in the U.S. St. Paul, Minnesota-based Cardio Flow designed FreedomFlow to provide support for diagnostic and therapeutic devices in treating plaque blockages in arteries above and below the knee. It has a stainless […]
FDA approves Medtronic’s In.Pact 018 drug-coated balloon catheter
Medtronic (NYSE:MDT) announced that it received FDA approval for its In.Pact 018 paclitaxel-coated balloon catheter. Fridley, Minnesota–based Medtronic’s In.Pact 018 paclitaxel-coated percutaneous transluminal angioplasty (PTA) balloon catheter, a drug-coated balloon product, received an indication for the interventional treatment of peripheral arterial disease (PAD) in the superficial femoral and popliteal arteries. According to a news release, […]
Abbott imaging catheter recall flagged as Class I by FDA
The FDA has identified the Abbott (NYSE:ABT) recall of its Dragonfly OpStar Imaging Catheter as a Class I recall. That’s the most serious level of a medical device recall, carrying the risk of serious injury or death. Five incidents, one injury and zero deaths were reported when Abbott initiated the recall on April 11. The […]
AccuPulse raises $10M Series A
AccuPulse Medical Technology announced that it recently raised more than $10 million in a Series A funding round. Shenzhen Qianhai Capital led the funding round, with Shanghai Biomedical Industry Equity Investment Fund and Yuanbio Ventures jointly investing. AccuPulse develops electrophysiology technology designed as a one-stop solution to treat cardiac arrhythmias, especially atrial fibrillation. Its product […]
Teleflex wins Health Canada nod for Manta vascular closure device
Teleflex (NYSE:TFX) today announced its Manta vascular closure device received Health Canada approval. Wayne, Pennsylvania-based Teleflex designed the Manta biomechanics vascular closure device for large bore femoral arterial access site closure. “Our team has been working diligently to obtain this approval and were confident that Health Canada would recognize the benefits of the Manta device,” […]
