• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer

MassDevice

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

  • Latest News
    • Cardiovascular
    • Orthopedics
  • Wall Street Beat
    • Funding Roundup
    • Mergers & Acquisitions
  • Podcasts & Webinars
    • Podcasts
    • Webinars
  • Resources
    • About MassDevice
    • Newsletter Signup
    • Leadership in Medtech
    • Manufacturers & Suppliers Search
    • MedTech 100 Index
    • Videos
    • Whitepapers
  • DeviceTalks Tuesdays
  • Coronavirus: Live updates
Home » 7 medtech stories we missed this week: May 19, 2017

7 medtech stories we missed this week: May 19, 2017

May 19, 2017 By Danielle Kirsh

missed medtech
[Image from unsplash.com]
From FDA clearances to touting study data, here are 7 medtech stories we missed this week but thought were still worth mentioning.

1. XpandOrtho wins FDA 510(k) clearance

XpandOrtho announced in a May 17 press release that it has received FDA 510(k) clearance for its electronic soft tissue balancing instrument for total knee replacement surgery. The sterile-packaged wireless disposable device uses miniature sensors and actuators to balance knee joints during full-range motions. Using constant pressure bellows systems, the device communicates with a display for multiaxial balance and selection of thickness and tibial component.

2. Visionsense goes after Novadaq patent

Visionsense has filed an IPR with the USPTO for its Novadaq Technologies’ U.S. patent, according to a May 16 press release. The patent is for a method for using fluorescence angiography to assess patency of vessel grafts. It is the only patent that Novadaq lists on its website as being associated with the SPY Elite system.

3. FDA clears Body Vision Medical’s LungVision navigation system

Body Vision Medical announced in a May 15 press release that it received FDA clearance to market its LungVision imaging system that enables accurate, real-time navigation and lesion localization during bronchoscopy procedures. LungVision has gone through clinical trials in the U.S., where it has been shown to be a sophisticated augmented reality approach for physicians to visualize, plan and track endobronchial tools and radiolucent lesions in real-time. The system also uses intraoperative fluoroscopy and pre-operative high-resolution imaging.

4. Rivanna Medical touts Accuro spinal navigation data

Rivanna Medical is touting data from its Accuro automatic spinal navigation system trial, according to a May 15 press release. The Accuro navigation system enhances the accuracy of epidural and spinal anesthesia placement for residents-in-training and patients with atypical spinal anatomy. The randomized trial was conducted at the University of Virginia and compared anesthesiology residents’ success placing spinal anesthesia in C-section patients using Accuro with traditional methods. The trial showed that residents who had prior spinal anesthesia experience had improved first-attempt needle placement using Accuro. First-attempt needle placement improved more than 100% in patients with a high body mass index. The second clinical trial, held at Stanford University, showed that Accuro identified appropriate spinal interspace for needle insertion in 94% of patients and was 87% successful in first-attempt epidural administration. The third trial, at Rutgers University, showed that Accuro successfully identified bony landmarks and the optimal spinal interspaces for anesthesia delivery.

5. Exactech gets 510(k) clearance for computer-aided shoulder arthroplasty technology

Exactech announced in a May 15 press release that it has received FDA 510(k) clearance to market its ExactechGPS Shoulder Application. Exactech combines preoperative planning with computer-assisted surgery for greater intraoperative visibility in both standard and challenging shoulder arthroplasty. It is designed to be a preoperative planning tool to help surgeons understand patient anatomy before surgery. It allows for visibility into the glenoid vault in real-time and allows physicians to have consistent and accurate glenoid placement.

6. NxThera touts 2-year Rezum prostate treatment

NxThera announced the 2-year outcome data for its Rezum System clinical trial to treat lower urinary tract symptoms (LUTS) caused by benign prostatic hyperplasia, according to a May 15 press release. The study showed that there was significant LUTS relief that stayed durable 2 years after treatment. 197 patients were enrolled in the study. The data showed durable symptom reduction and preserved sexual function in patients who were treated with Rezum.

7. Lombard launches Altura registry study

Lombard Medical announced in a May 15 press release that it has enrolled and treated the first patient in its global registry to evaluate Altura Endograft System. The study is being conducted on 1,000 patients in clinical use conditions. Altura Endograft System study is designed to study the impact on the treatment of abdominal aortic aneurysms using a D-stent EVAR design.

Here’s what we missed last week.

Filed Under: 510(k), Clinical Trials, Food & Drug Administration (FDA), Regulatory/Compliance, Research & Development Tagged With: Body Vision Medical, Exactech Inc., lombardmedical, MedTech, NxThera Inc., Rivanna Medical, Visionsense, XpandOrtho

In case you missed it

  • Orchestra BioMed to go public, partner with Medtronic on cardiac neuromodulation therapy
  • Memic Innovative Surgery is now Momentis Surgical
  • Lyra Therapeutics appoints new chief medical officer
  • Masimo’s SafetyNet monitoring reduced length of COVID-19 hospital stays, study says
  • CeQur is launching a discreet, convenient ‘wearable insulin pen’
  • Teva appoints former Vertex exec as new head of R&D, CMO
  • Enovis partners with Kelvi on hot and cold therapies
  • West Pharmaceutical Services debuts new needle syringe system
  • Titan Medical names Cary G. Vance as new president, CEO
  • Acutus completes first closing in left-heart access portfolio sale to Medtronic
  • FDA clears Intuitive, Siemens Healthineers imaging integration for robotic bronchoscopy
  • FDA backs COVID-19 boosters with BA.4/5 spike proteins for fall
  • How safe is health information after the overturning of Roe?
  • Smith+Nephew opens new plant in Malaysia
  • BD launches combination COVID-19, flu, RSV diagnostic test
  • Zimmer Biomet creates independent nonprofit organization to reduce health disparities
  • Dexcom focuses on early diabetes diagnosis as COVID links emerge

RSS From Medical Design & Outsourcing

  • DeviceTalks Boston 2022: Here’s what you missed on the show floor
    At DeviceTalks Boston 2022, there was a wealth of expertise to be had from exhibitors including Viant, ICS, PSN Labs, Propel and more. From stories of overcoming challenges during the COVID-19 pandemic to medical device materials pitfalls to avoid, MassDevice and MDO executive editor Chris Newmarker hit the DeviceTalks Boston show floor to discover insights. […]
  • Supply Chain EVP Greg Smith sees fewer suppliers in Medtronic’s future
    All eyes are on Medtronic’s global operations and supply chain leader as he works to modernize its operations and scrutinize suppliers. EVP of Global Operations and Supply Chain Greg Smith anticipates fewer suppliers in Medtronic’s future, he said in an interview this week. Smith spoke with DeviceTalks Editorial Director Tom Salemi in his first published… […]
  • CeQur is launching a discreet, convenient ‘wearable insulin pen’
    CeQur designed its Simplicity device to make insulin delivery as seamless as possible for people with diabetes. When it comes to managing diabetes, CeQur wants to make insulin therapy as convenient as possible. For those who prefer to manage their own insulin delivery, the Simplicity device might just do exactly that. Simplicity, a wearable, disposable… […]
  • Meddux opens new facility in Colorado
    Engineering, design, development and manufacturing company Meddux announced that it opened a new facility in Boulder, Colorado. The new, 22,000-square-foot facility doubles the overall square footage from its previous location in Colorado. According to a news release, it helps the company to quadruple its product development area and double its manufacturing footprint. Meddux’s new facility… […]
  • Reducing the Overall Cost of Validation
    By PTI Engineered Plastics Reliable medical devices and equipment are essential for researchers and doctors to accurately diagnose and treat a wide range of diseases. That is why there is such stringent oversight from the FDA to ensure these products meet the necessary requirements and specifications. To ensure compliance with regulators, manufacturers follow installation qualification… […]
  • BBS Automation has a deal to buy medtech supplier Kahle Automation
    BBS Automation said it plans to purchase high-speed automation supplier Kahle Automation to expand its medtech and life sciences business. Kahle will operate as Kahle – a BBS Company, according to a news release from Munich, Germany-based BBS and Lombardy, Italy-based Kahle. The deal is subject to regulatory approval. Terms were not disclosed. Kahle’s co-owners —… […]
  • How safe is health information after the overturning of Roe?
    The U.S. Department of Health and Human Services today issued guidance meant to better protect women’s health information as state abortion bans kick in after the U.S. Supreme Court’s overturning of Roe v. Wade. Despite the HHS actions, women may still wonder whether their health information is entirely safe going forward — a potential challenge… […]
  • Dexcom focuses on early diabetes diagnosis as COVID links emerge
    New evidence is showing that COVID-19 may increase a person’s risk of diabetes, but it could be years until we know for sure. In the meantime, Dexcom (Nasdaq:DXCM) is getting ready, VP of Global Clinical Initiatives Tomas Walker said. Walker recently spoke with Medical Design & Outsourcing to discuss the San Diego-based diabetes device developer’s… […]
  • Blackrock Neurotech and Pitt work on first at-home BCI system for remote trials
    Blackrock Neurotech and the University of Pittsburgh’s Rehab Neural Engineering Labs (Pitt RNEL) are working together on the first portable brain-computer interface (BCI) to allow patients to participate in research trials from home. A Blackrock representative said it’s the final step as the company prepares to launch its first commercial product early next year. Salt… […]
  • How medical device companies are responding to abortion bans
    Days after the U.S. Supreme Court’s decision to overturn Roe v. Wade’s protection of abortion rights, medical device companies are among those reassuring workers about healthcare access. Corporate communications to employees and the public at large come as trigger laws in nearly half of the states outlaw abortion immediately. Some medtech companies are not using… […]
  • Philips updates on testing results for recalled ventilators
    Royal Philips (NYSE:PHG) says only a small portion of returned respiratory devices displayed the sound abatement foam degradation that sparked a massive recall. Repeated ozone cleaning may have made the problem worse. Those were some of the major takeaways from an update Philips provided today on a comprehensive test and research program it implemented after its… […]

Primary Sidebar

DeviceTalks Weekly

July 1, 2022
Boston Scientific CEO Mike Mahoney on building a corporate culture that drives high growth results
See More >

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
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.

MDO ad

Footer

MASSDEVICE MEDICAL NETWORK

DeviceTalks
Drug Delivery Business News
Medical Design & Outsourcing
Medical Tubing + Extrusion
Drug Discovery & Development
Pharmaceutical Processing World
MedTech 100 Index
R&D World

Device Talks Webinars, Podcasts, & Discussions

Attend our Monthly Webinars
Listen to our Weekly Podcasts
Join our Device Talks Tuesdays Discussion

MASSDEVICE

Subscribe to MassDevice E-Newsletter
Advertise with us
About
Contact us
Add us on Facebook Follow us on Twitter Connect with us on LinkedIn Follow us on YouTube

Copyright © 2022 · 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