MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

  • Latest News
  • Cardiovascular
  • Orthopedics
  • Wall Street Beat
    • Funding Roundup
    • Mergers & Acquisitions
  • Podcasts
    • MPR: Breakthrough Products Series
  • Resources
    • About MassDevice
    • Newsletter Signup
    • Job Board
    • Leadership in Medtech
    • Manufacturer Search
    • Videos
    • Whitepapers
  • DeviceTalks
You are here: Home / Regulatory/Compliance / Food & Drug Administration (FDA) / 510(k) / 7 medtech stories we missed this week: June 8, 2018

7 medtech stories we missed this week: June 8, 2018

June 8, 2018 By Danielle Kirsh Leave a Comment

missed-medtech-0323

[Image from unsplash.com]

From Royal Philips receiving FDA clearance to NeuroPace launching its epilepsy treatment device, here are seven medtech stories we missed this week but thought were still worth mentioning.

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.

Filed Under: 510(k), Diagnostics, Endoscopic, Food & Drug Administration (FDA), Hospital Care, Imaging, Implants, Neurological, Neuromodulation/Neurostimulation, Patient Monitoring, Regulatory/Compliance Tagged With: branchpointtechnologies, Cook Medical, MedTech, NeuroPace, Pentax, Philips, Rodo Medical, Spineology, taewoonmedical

In case you missed it

  • Employees say Intuitive Surgical, J&J, Stryker best places to work in 2020
  • Eitan Group signs service agreement with Integrated Medical Systems
  • Beta Bionics’ bionic pancreas wins breakthrough status from FDA
  • Sanofi backs away from diabetes partnership with Verily
  • FDA clears Cochlear piezoelectric hearing implant
  • Biolase lands 510(k) for dental hygiene laser
  • Mayo Clinic, W.L. Gore team up on stem cell therapy treatments
  • ViewRay issues urgent field safety notice for MRIdian System Treatment Planning and Delivery System
  • Barry out as InspireMD CEO
  • Report: EtO blood levels higher in Illinois neighbors of Medline sterilization plant
  • FDA clears augmented glenoids for Shoulder Innovations system
  • McKesson names new chief information and technology officer
  • Imperative Care raises $85m
  • CMR Surgical appoints new CEO
  • Peregrine Ventures raises $115m
  • Roche wins CE Mark for blood glucose reading smartphone app
  • Cantel Medical beats The Street in Q1 results

RSS From Medical Design & Outsourcing

Leave a Reply Cancel reply

You must be logged in to post a comment.

Need Medtech news in a minute?
We Deliver!

MassDevice Enewsletters get you caught up on all the mission critical news you need in med tech. Sign up today.

Popular Posts

  • Report: SEC probes GE Healthcare, Philips, Siemens in Chinese bribery scheme
  • Edwards Lifesciences warns against below-market mini-tender offer Edwards Lifesciences
  • J&J’s Ethicon files ITC complaint against Intuitive Surgical Intuitive Surgical's EndoWrist instruments
  • Auris Health loses motion to move Intuitive Surgical patent suit from Del. to Cali. Johnson & Johnson's Auris, Intuitive Surgical
  • Enable Injections inks deal with Sanofi for drug delivery platform enfuse-enable-injections
Tweets by @MassDevice
MDO ad

MASSDEVICE MEDICAL NETWORK

DeviceTalks
Drug Delivery Business News
Medical Design & Outsourcing
Medical Tubing + Extrusion

MASSDEVICE

Subscribe to MassDevice
Advertise with us
About
Contact us
Add us on FacebookMassDevice Network
Follow us on Twitter@MassDevice
Connect with us on LinkedInLinkedIn
Follow us on YouTube YouTube

Copyright © 2019 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Advertise | Privacy Policy | RSS