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

MassDevice

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

  • Latest News
  • Technologies
    • Artificial Intelligence (AI)
    • Cardiovascular
    • Orthopedics
    • Neurological
    • Diabetes
    • Surgical Robotics
  • Business & Finance
    • Wall Street Beat
    • Earnings Reports
    • Funding Roundup
    • Mergers & Acquisitions
    • Initial Public Offering (IPO)
    • Legal News
    • Personnel Moves
    • Medtech 100 Stock Index
  • Regulatory & Compliance
    • Food & Drug Administration (FDA)
    • Recalls
    • 510(k)
    • Pre-Market Approval (PMA)
    • MDSAP
    • Clinical Trials
  • Special Content
    • Special Reports
    • In-Depth Coverage
    • DeviceTalks
  • Podcasts
    • MassDevice Fast Five
    • DeviceTalks Weekly
    • OEM Talks
      • AbbottTalks
      • Boston ScientificTalks
      • DeviceTalks AI
      • IntuitiveTalks
      • MedtechWOMEN Talks
      • MedtronicTalks
      • Neuro Innovation Talks
      • Ortho Innovation Talks
      • Structural Heart Talks
      • StrykerTalks
  • Resources
    • About MassDevice
    • DeviceTalks
    • Newsletter Signup
    • Leadership in Medtech
    • Manufacturers & Suppliers Search
    • MedTech100 Index
    • Videos
    • Webinars
    • Whitepapers
    • Voices

Presbia

Presbia abandons Flexivue microlens, lays off all but 3

April 23, 2019 By Brad Perriello

Presbia (NSDQ:LENS) yesterday said it spiked its Flexivue microlens development program in the face of FDA headwinds, laying off all but three of its employees as it seeks investors to bail it out. Earlier this month the Irvine, Calif.-based company delayed the pre-market approval timeline for Flexivue, which is designed to treat far-sightedness or presbyopia, after […]

Filed Under: Featured, Mergers & Acquisitions, Optical/Ophthalmic, Wall Street Beat Tagged With: Presbia

Presbia delays Flexivue Microlens FDA PMA approval timeline again

April 5, 2019 By Fink Densford

Presbia (NSDQ:LENS) has delayed the timeline for approval of its Flexivue Microlens for treating far-sightedness again due to an earlier request for more information from the FDA. The Irvine, Calif.-based company was told last October that it had 180 days to provide the agency with 36-month data from all subjects enrolled in the staged pivotal clinical […]

Filed Under: Food & Drug Administration (FDA), Optical/Ophthalmic, Pre-Market Approval (PMA), Regulatory/Compliance Tagged With: Presbia

3M names CEO Roman as board chair | Personnel Moves – February 7, 2019

February 7, 2019 By Fink Densford

3M (NYSE:MMM) said yesterday that its board of directors nominated CEO Mike Roman as its new chairperson, with current exec chair Inge Thulin announcing their intention to retire. The move is slated to take effect following the St. Paul, Minn.-based company’s annual meeting of shareholders on May 14. “Under Inge’s leadership, 3M evolved into a more […]

Filed Under: Business/Financial News, Featured, Wall Street Beat Tagged With: 3m, AdvaMed, Amazon, Biospace Med, Boston Scientific, Digirad Corp., excelmedical, Medtronic, Misonix, Myomo Inc, NxThera Inc., Presbia, Repro-Med Systems Inc., SPR Therapeutics, venturemed

Presbia reaches ISO medical device quality milestone

January 14, 2019 By Chris Newmarker

Presbia (Nasdaq:LENS) said today that it has successfully completed the ISO 13485:2016 audit with no major findings. Officials at the Dublin, Ireland–based ophthalmic device company described the audit completion as an essential step toward recertifying under the ISO standard. The company – which has administrative offices and manufacturing in Irvine, Calif. – will receive annual surveillance […]

Filed Under: Business/Financial News, News Well, Optical/Ophthalmic, Regulatory/Compliance Tagged With: Presbia

Presbia plunges on one-year delay for Flexivue Microlens approval

October 15, 2018 By Brad Perriello

Presbia (NSDQ:LENS) last week delayed the timeline for FDA approval of its Flexivue Microlens for treating far-sightedness after the federal safety watchdog said it wanted another year’s worth of data on the device. Irvine, Calif.-based Presbia submitted its final pre-market approval module to the FDA during the second quarter, including 24-month data for the Flexivue device, saying […]

Filed Under: Featured, Food & Drug Administration (FDA), Optical/Ophthalmic, Regulatory/Compliance, Wall Street Beat Tagged With: Presbia

Endologix CEO McDermott to step down; shares slide -10% on Q4 results | Personnel Moves for Feb. 22, 2018

February 22, 2018 By Brad Perriello

Endologix (NSDQ:ELGX) CEO John McDermott is planning to step down once an appropriate replacement is found, the company said yesterday as it announced fourth-quarter results that handily topped earnings expectations but missed on the top line. “Despite the business challenges over the past couple of years, I am confident that Endologix has a bright future. Our […]

Filed Under: MassDevice Earnings Roundup, Stent Grafts, Wall Street Beat Tagged With: attunemedical, Biocoat, Cardiovascular Systems Inc., Dynatronics Corp, Endologix, Medtronic, Personnel Moves, Presbia, Wound Management Technologies

Vascular Dynamics taps ex-Ellipse Tech CEO Roschak as chief exec | Personnel Moves December 15, 2017

December 15, 2017 By Fink Densford

Vascular Dynamics said early this month it tapped former NuVasive Inc. (NSDQ:NUVA) exec and Ellipse Technologies CEO Ed Roschak as its new president and chief executive. Prior to joining Mountain View, Calif.-based Vascular Dynamics, Roschak served as prez and CEO of Ellipse Technologies, which he saw through a $410 million acquisition by NuVasive. He then took up […]

Filed Under: Business/Financial News Tagged With: Aptus EndoSystems Inc., Asante Solutions, Avanos Medical (formerly Halyard Health), Boston Scientific, Cutera Inc., Ellipse Technologies Inc., Encision Inc., Genoptix Inc., Hologic, Johnson and Johnson, Novartis, Nuvasive, Presbia, regentys, tandemdiabetes, Tria Beauty Inc., vasculardynamics, Ventus Medical Inc., Vermillion Inc., wishbonemedical

Presbia touts preliminary data from Microlens PMA trial

May 26, 2017 By Fink Densford

Presbia (NSDQ:LENS) this week reported preliminary data from a US pivotal clinical trial of its Flexivue Microlens, touting that over 80% of subjects had shown significant improvements in vision. The Ireland-based company said it is 27 months into the 3-year trial which it hopes will support US FDA Premarket Approval, and that so far, 100% of subjects […]

Filed Under: Clinical Trials, Optical/Ophthalmic Tagged With: Presbia

Presbia extends $13.5m rights offering to March

February 23, 2017 By Fink Densford

Presbia (NSDQ:LENS) said yesterday it is extending its $13.5 million rights offering, set to expire today, until March 8. The Dublin-based company is looking to float 4.5 million shares at $3 per share to its current shareholders. Each shareholder will receive 0.33 subscription rights per ordinary share owned during the offering. Subscription rights are non-transferable and non-tradable, and […]

Filed Under: Business/Financial News Tagged With: Presbia

Presbia prices $13.5m rights offering

January 27, 2017 By Fink Densford

Presbia (NSDQ:LENS) today priced an upcoming rights offering, looking to offer up to 4.5 million shares at $3 per share, netting the company as much as $13.5 million. The offering will go out to current shareholders, with 0.33 subscription rights being offered for each ordinary share owned. The offering will begin on Feb. 6, 2017 and […]

Filed Under: Business/Financial News, Optical/Ophthalmic Tagged With: Presbia

Smith & Nephew pulls the trigger on planned CFO succession | Personnel Moves | January 20, 2017

January 20, 2017 By Brad Perriello

Smith & Nephew (NYSE:SNN) said last week that CFO Julie Brown left the orthopedics & wound care company, after announcing her succession last July. Brown was named finance chief in November 2012 and assumed the role in February the following year. She is moving on to work as chief operating & financial officer for British luxury brand […]

Filed Under: Business/Financial News Tagged With: Apollo Endosurgery, Biolase, Endologix, Fresenius, Hologic, IsoRay, Merrimack Pharmaceuticals, Personnel Moves, Presbia, Smith & Nephew, SurgaColl

  • Page 1
  • Page 2
  • Page 3
  • Go to Next Page »

Primary Sidebar

“md
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest med device regulatory, business and technology news.

DeviceTalks Weekly

See More >

MEDTECH 100 Stock 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.
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
Medical Design Sourcing

DeviceTalks Webinars, Podcasts, & Discussions

Attend our Monthly Webinars
Listen to our Weekly Podcasts
Join our DeviceTalks Tuesdays Discussion

MASSDEVICE

Subscribe to MassDevice E-Newsletter
Advertise with us
About
Contact us

Copyright © 2025 · 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.

Privacy Policy