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Endoscopic

CardioFocus wins FDA approval for HeartLight X3 endoscopic ablation system

May 12, 2020 By Sean Whooley

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 […]

Filed Under: 510(k), Cardiovascular, Endoscopic, Food & Drug Administration (FDA), Pre-Market Approval (PMA), Regulatory/Compliance, Vascular Tagged With: Cardiofocus, FDA

Ambu to launch single-use endoscopy device

May 5, 2020 By Sean Whooley

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 […]

Filed Under: Business/Financial News, Endoscopic, Food & Drug Administration (FDA), Imaging, Regulatory/Compliance Tagged With: Ambu

These medical devices are getting ready to launch in 2020

April 28, 2020 By Danielle Kirsh

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 […]

Filed Under: Cardiac Implants, Endoscopic, Featured, Imaging, Implants, Research & Development, Robotics, Structural Heart, Surgical, Vascular Tagged With: Boston Scientific, Edwards Lifesciences, Johnson and Johnson, Medtronic

Olympus launches Evis X1 endoscopy system

April 23, 2020 By Danielle Kirsh

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 […]

Filed Under: Diagnostics, Endoscopic, Imaging Tagged With: Olympus

CMS recommends postponing most elective procedures

March 19, 2020 By Nancy Crotti

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 […]

Filed Under: Cardiovascular, Cosmetic/Aesthetic, Dental, Endoscopic, Featured, Hospital Care, Medicare, Neurological, Oncology, Optical/Ophthalmic, Orthopedics, Otolaryngology/Ear, Nose & Throat (ENT), Surgical, Transplants, Vascular Tagged With: Centers for Medicare and Medicaid Services (CMS), coronavirus

Pavmed’s Lucid Diagnostics enters clinical trial with U of Penn

March 2, 2020 By Sean Whooley

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 […]

Filed Under: Clinical Trials, Endoscopic, Featured, Otolaryngology/Ear, Nose & Throat (ENT) Tagged With: Lucid Diagnostics, Pavmed, University of Pennsylvania

FDA clears Olympus duodenoscope with disposable endcap

February 3, 2020 By Danielle Kirsh

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 […]

Filed Under: Endoscopic, Featured, Food & Drug Administration (FDA), Imaging Tagged With: duodenoscope, Olympus

Ascyrus Medical raises $5.2m

January 31, 2020 By Sean Whooley

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 […]

Filed Under: Business/Financial News, Endoscopic, Funding Roundup, Stent Grafts Tagged With: ascyrusmedical

How LED light can break down ingestible medical devices

January 27, 2020 By Danielle Kirsh

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 […]

Filed Under: Cardiovascular, Endoscopic, Featured Tagged With: Massachusetts Institute of Technology

Boston Sci wins CE Mark for disposable duodenoscope Exalt Model D

January 23, 2020 By Danielle Kirsh

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 […]

Filed Under: Endoscopic, Featured, Regulatory/Compliance Tagged With: Boston Scientific

Gore announces some Excluder problems in Europe

January 17, 2020 By Sean Whooley

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 […]

Filed Under: Cardiovascular, Endoscopic, Featured, Recalls, Regulatory/Compliance, Stent Grafts, Vascular Tagged With: W.L. Gore & Associates

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