1. FDA clears Philips’s Ingenia Elition 3.0T MR scanner
Royal Philips announced in a June 5 press releasethat it has received FDA 510(k) clearance for its Ingenia Elition 3.0T MR solution and its two clinical applications Philips Compressed Sense and 3D APT. The products help clinicians perform exams up to 50% faster while increasing diagnostic confidence and improving patient experience.
2. Pentax to distribute CapsoCam Plus
Pentax has entered an exclusive distribution agreement with CapsoVision in the U.S. to distribute the CapsoCam Plus Capsule Endoscopy line of products, according to a June 4 press release. Under the agreement, Pentax will serve as the U.S. sales agent for the CapsoCam Plus System, including CapsoCloud and CapsoView. The CapsoCam Plus System is a user-friendly capsule endoscopy solution that has a full 360º image of the small bowel mucosa. Its panoramic lateral view camera is designed to improve diagnostic confidence by overcoming field of view limitations that comes with end-facing cameras.
3. Cook Medical to distribute Taewoon Medical’s GI stents
Cook Medical and Taewoon Medical announced in a June 4 press releasethat Cook Medical will distribute Taewoon Medical’s stents throughout the U.S. The agreement includes the company’s Niti-S Through the Scope (TTS) Esophageal Stent. Cook Medical will begin distributing the stents on Nov. 1 this year. The Niti-S TTS Esophageal Stent is preloaded in a 10.5 Fr delivery system. The scope can then be delivered with a conical tip that is designed to navigate tight structures and tortuous anatomies.
At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. Shultz will take attendees behind the story that everyone is talking about: the rise and fall of Elizabeth Holmes and her diagnostic company, Theranos.
Join Shultz and 1,000+ medical device professionals at the 8th annual DeviceTalks Boston.