1. FDA clears Philips’s Ingenia Elition 3.0T MR scanner
Royal Philips announced in a June 5 press release that 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 release that 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.
4. FDA clears Spineology’s Rampart One ALIF device for stand-alone use
Spineology received FDA clearance for its Rampart One Standard ALIF device for stand-alone use, according to a June 4 press release. The Rampart One ALIF Interbody Fusion System is an anatomy-conserving technology from Spineology. It includes standard and oblique interbody devices with integrated fixation screws. The system is designed to minimize vascular retraction and exposure to maximize safety.
5. FDA clears Rodo Medical’s Smilekey
Rodo Medical announced in a June 4 press release that it has received FDA 510(k) clearance for its Rodo Smilekey induction remover device for use with the Rodo Abutment System. The system uses induction technology to remove dental prostheses retained by the Rodo Smileloc in less than 10 seconds without occlusal holes or damaging the prostheses. It provides a safe and easy remodel of single-tooth restorations and multi-unit prostheses.
6. NeuroPace launches Next Gen RNS epilepsy neurostim device
Neuropace has launched its Next Gen RNS System to treat refractory epilepsy, according to a June 1 press release. The RNS System is a brain-computer interface that treats seizures by monitoring brain waves and recognizing a patient’s unique seizure onset fingerprint while responding with imperceptible electrical pulses before a seizure can occur. The Next Gen RNS System has a battery life of 8.4 years at medium stimulation.
7. FDA clears Branchpoint Tech intracranial pressure monitoring system
Branchpoint Technologies announced in a May 31 press release that it has received FDA 510(k) clearance for its Aura Intracranial Pressure Monitoring System. The system includes a fully implantable and wireless intracranial pressure (ICP) sensor that enables mobile ICP monitoring in brain-injured patients. The Aura system is completely wireless in power and transmission of patient data directly to a bedside monitor. It also allows for continuous telemetric monitoring of parenchymal ICP including continuous waveforms.