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 […]
Pentax Medical launches Imagina endoscope in U.S.
Hoya (TYO:7741) subsidiary Pentax Medical announced that it won FDA 510(k) clearance for its Imagina endoscopy system and initiated the device’s U.S. launch. The Imagina system is designed to perform gastrointestinal (GI) procedures at ambulatory surgery centers (ASCs). It features a touch-screen LCD interface while eliminating the need for periodic bulb replacements. It also includes the […]
Boston Scientific wins a round in patent spat with Micro-Tech
A federal judge in Delaware ruled yesterday that Boston Scientific may proceed in its patent dispute with Micro-Tech over hemostatic endoscopy clips. Boston Scientific filed the lawsuit against Micro-Tech USA and its Chinese manufacturer, Micro-Tech Nanjing, alleging that they infringed three of its patents for endoscopic hemostatic clips. Henry Schein (Melville, N.Y.) is named as […]
The 10 greatest medtech advances of the 2010s
From disposable endoscopes to TAVR to robotic surgery, there’s a whole host of medtech advances widely available now that weren’t around much 10 years ago. “In terms of technological advances, I would put this past decade as one of the most important for medical technology. From connected devices and robotics, to advances in material sciences […]
CDx Diagnostics raises $11m for tech to spot pre-cancerous cells in esophagus
CDx Diagnostics‘ parent company has raised more than $11 million in its latest money-raise as it continues to promote its WATS3D diagnostic platform for spotting pre-cancerous cells in the esophagus. Six investors provided money to CDx Medical Holdings, according to the SEC Form D dated Dec. 16. The company had sought up to $17.3 million. […]
FDA clears first single-use duodenoscope from Boston Sci
The FDA said it cleared the first fully disposable duodenoscope, made by Boston Scientific. 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 market and was granted Breakthrough Device Designation. “The availability of a fully disposable duodenoscope represents another major step […]
CryoLife wins CE Mark for E-nya thoracic stent graft
CryoLife Inc. (NYSE:CRY) announced that it received CE Mark approval for its E-nya thoracic stent graft system for minimally invasive procedures intended to repair lesions of the descending thoracic aorta, including thoracic aortic aneurysms and dissections. In December 2017, CryoLife completed the $225 million acquisition of German stent graft and surgical graft maker Jotec. Kennesaw, Ga.-based […]
Pentax has a duodenoscope meant to reduce superbug fears — and now it’s for sale in the U.S.
Hoya (TYO:7741) subsidiary Pentax Medical has announced the U.S. launch of its DEC HD duodenoscope, which boasts a sterile, disposable elevator meant to reduce reprocessing challenges associated with the device. The news, released yesterday, comes about a week after FDA announced clearance of the Pentax duodenoscope. The DEC HD duodenoscope has been available in global […]
BREAKING: FDA clears Pentax Medical duodenoscope meant to reduce superbug fears
The FDA today announced that it has cleared a duodenoscope from Hoya’s (TYO:7741) Pentax subsidiary that has a sterile, disposable elevator — a first in the U.S. The Pentax Medical duodenoscope’s design reduces the number of parts requiring cleaning and disinfection between uses, according to the FDA. Reducing reprocessing challenges, the thinking goes, will help prevent […]
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