CardioFocus announced today that it received FDA approval for its next-generation HeartLight X3 endoscopic ablation system. Marlborough, Mass.-based CardioFocus’ system treats drug-refractory recurrent symptomatic paroxysmal atrial fibrillation (PAF). Last year, the company won CE Mark approval in Europe for the device and in February of this year, it announced that it sought out a PMA […]
Endoscopic
Ambu to launch single-use endoscopy device
Ambu announced today that it will launch its Ambu aView 2 Advance display unit for use with endoscopes in Europe and the U.S. Denmark-based Ambu received CE Mark and FDA approval to market its portable, full-HD unit that combines with single-use endoscopes across multiple clinical areas. The Ambu aView 2 Advance connects with Ambu’s aScope […]
These medical devices are getting ready to launch in 2020
Despite the COVID-19 pandemic, medical device companies are still working to gain regulatory approvals and launch new devices this year. The pandemic has largely fixed the FDA’s focus on emergency use authorizations (EUAs), leaving more typical device approvals waiting. At press time, the regulatory agency had granted 84 EUAs beginning Feb. 4 and had approved […]
Olympus launches Evis X1 endoscopy system
Olympus today said it launched its Evis X1 endoscopy system. Evis X1 is designed to improve outcomes from disorders of the stomach, colon and esophagus as well as various bronchial diseases. It features easy-to-use technologies to support how gastrointestinal disorders like colorectal cancer (CRC) are detected, characterized and treated. The system features extended depth of […]
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 […]
Pavmed’s Lucid Diagnostics enters clinical trial with U of Penn
Pavmed (NSDQ:PAVM) announced today that its majority-owned subsidiary Lucid Diagnostics entered into a clinical trial research agreement with the University of Pennsylvania to observe its EsoCheck esophageal cell collection device. EsoCheck with “collect & protect technology” is designed to offer a less invasive, more efficient and cost-effective alternative to endoscopic biopsies when managing patients with eosinophilic […]
FDA clears Olympus duodenoscope with disposable endcap
Olympus (TYO:7733) announced that it won FDA clearance for its TJF-Q190V duodenoscope with a sterile, disposable distal endcap. The new duodenoscopes are designed to improve the cleaning and reprocessing of the device to reduce contamination. The device is a result of the FDA’s call for more duodenoscopes that are disposable. FDA in August 2019 recommended that […]
Ascyrus Medical raises $5.2m
Aortic dissection stent graft maker Ascyrus Medical announced that it sold nearly $5.2 million in an equity offering. The Boca Raton, Fla.–based company has no equity left to be sold in the offering, having collected approximately $5.18 million from six different investors. The minimum investment accepted was $39,997. Ascyrus Medical did not disclose the issuer […]
How LED light can break down ingestible medical devices
Researchers at the Massachusetts Institute of Technology have developed an approach to break down ingestible medical devices in the gastrointestinal tract. Medical devices can be inserted in the gastrointestinal tract to treat, diagnose or monitor a number of GI disorders. However, the devices have to removed through endoscopic surgery once completed. The MIT researchers developed […]
Boston Sci wins CE Mark for disposable duodenoscope Exalt Model D
Boston Scientific (NYSE:BSX) this week received CE Mark approval for its Exalt disposable duodenoscope. The Exalt Model D Single-Use Duodenoscope is designed for use in endoscopic retrograde cholangiopancreatography procedures. It is the first single-use duodenoscope on the U.S. market and was granted Breakthrough Device Designation. The FDA cleared the device late last year. “Following on from […]
Gore announces some Excluder problems in Europe
W.L. Gore & Associates issued an urgent field safety notice in Europe to warn on issues with its Excluder AAA Endoprosthesis and Excluder Iliac Branch. Both Excluder products may experience the separation of the leading end of catheter components, according to the safety notice out of Germany. From January 2013 to Aug. 5, 2019, Gore […]
