• 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

avitamedical

Avita Medical wins FDA investigational device exemption approval for Recell System for vitiligo

January 3, 2020 By Danielle Kirsh

Avita Medical (ASX:AVH) said it received FDA investigational device exemption approval for a study to evaluate its Recell System for vitiligo. The company plans to conduct a feasibility study to evaluate the system’s safety and effectiveness for repigmentation of depigmented lesions that are associated with stable vitiligo. “Vitiligo affects approximately 6.5 million people in the U.S., […]

Filed Under: Food & Drug Administration (FDA) Tagged With: avitamedical

Avita Medical appoints new CFO

November 18, 2019 By Danielle Kirsh

Avita Medical (ASX:AVH) yesterday announced it appointed David McIntyre as chief financial officer, effective Nov. 18. McIntyre will be responsible for overseeing global finance and investor relations. He replaces interim CFO Tim Rooney, who will continue as the company’s chief administrative officer. “David’s extensive background in global finance, operations and law, in combination with his experience […]

Filed Under: Business/Financial News, Featured Tagged With: avitamedical

FDA OKS Avita Medical trial for Recell in soft tissue reconstruction

September 17, 2019 By Sean Whooley

Avita Medical (ASX:AVH) said yesterday that the FDA approved an investigational device exemption for a pivotal trial of its Recell autologous cell harvesting device. The Valencia, Calif.-based company said the 65-patient study is designed to compare conventional skin grafting with and without Recell system. Each patient is slated for a control wound treated with a conventional […]

Filed Under: Clinical Trials, Cosmetic/Aesthetic, Food & Drug Administration (FDA), Regulatory/Compliance, Surgical Tagged With: avitamedical

‘Berkmorgazon’ health play Haven COO Stoddard steps away | Personnel Moves – May 17, 2019

May 17, 2019 By Fink Densford

Healthcare joint venture Haven, started by Amazon (NSDQ:AMZN), Berkshire Hathaway and J.P. Morgan, has lost its COO Jack Stoddard at just nine months post-hiring, according to a CNBC report. The former digital health general manager for Comcast told the news channel that he is departing the healthcare play due to personal reasons, including the distance between […]

Filed Under: Business/Financial News Tagged With: Amazon, avitamedical, Berkshire Hathaway, Boston Scientific, Cantel Medical Corp., Fresenius, gerresheimer, haven, JP Morgan Chase, oculartherapeutix, proteor, Pulmatrix Inc.

Avita says EU sales temporarily interrupted, inks Japanese distro deal for Recell

March 4, 2019 By Fink Densford

Avita Medical (ASX:AVH) said yesterday that sales of its Recell device in the European Union were temporarily interrupted due to an administrative issue with its notified body and announced a new Japanese marketing and distribution deal. The Valencia, Calif.-based company said that the sales interruption occurred after its EU-based notified body “reported open items related to […]

Filed Under: Business/Financial News, Distribution, Featured, Regulatory/Compliance, Wound Care Tagged With: avitamedical

Avita Medical raises $14m

February 6, 2019 By Fink Densford

Avita Medical (ASX:AVH) has raised approximately $14.4 million in a new round of equity financing, according to a recently posted SEC filing. Funds in the round came from a single unnamed source, with the first sale noted as having occurred on December 7, 2018. The company paid approximately $1.3 million in finders fees for the offering, […]

Filed Under: Business/Financial News, Wall Street Beat Tagged With: avitamedical

Avita Medical raises $9m, wins $1m R&D tax credit

December 20, 2018 By Fink Densford

Avita Medical (ASX:AVH) has raised $8.9 million in a new round of equity financing and obtained an approximately $1 million (AUD $1.4 million) research and development tax credit from the Australian Tax Office, according to recently released documents from the company. The $8.9 million funding round included participation from a single anonymous investor, according to an […]

Filed Under: Business/Financial News, Wall Street Beat Tagged With: avitamedical

Senseonics CFO Elsey to retire | Personnel Moves – December 4, 2018

December 4, 2018 By Fink Densford

Senseonics (NYSE:SENS) said yesterday that its CFO R. Elsey is retiring for the company, and that it has begun searching for a permanent replacement. The Germantown, Md.-based company said that Elsey will stay on until a replacement is appointed, and remain on in an advisory role through to the completion of the company’s 2018 fiscal […]

Filed Under: Business/Financial News Tagged With: Accuray Inc., avitamedical, Baxter, Hillrom, Senseonics, ViewRay Inc., Visioneering Technologies

Avita launches pediatric burn trial

October 25, 2018 By Fink Densford

Avita Medical (ASX:AVH) said today that it launched a new trial of its Recell autologous cell harvesting device exploring its use treating pediatric patients. The Recell autologous cell harvesting device is designed to use the patient’s own skin cells to treat a variety of skin issues, including burns, reconstructive and cosmetic procedures, the Valencia, Calif.-based company […]

Filed Under: Clinical Trials, Regenerative Medicine, Wound Care Tagged With: avitamedical

Avita Medical lands tax credit Down Under

September 26, 2018 By Fink Densford

Avita Medical (ASX:AVH) said today that it received a $730,000 (AUD $1 million) Research and Development Tax cash rebate from the Australian Tax Office for its year ending June 30, 2017. The Valencia, Calif.-based company said the incentive program is designed to provide a cash rebate to support companies in Australia undertaking R&D projects. Avita said […]

Filed Under: Business/Financial News Tagged With: avitamedical

Avita Medical wins FDA PMA for Recell severe burn treatment device

September 21, 2018 By Fink Densford

Avita Medical (ASX:AVH) said today that it won FDA premarket approval for its Recell autologous cell harvesting device, now cleared for use in treating severe thermal burns in patients 18 and older, and that it plans to launch the device in the fourth quarter. The Recell autologous cell harvesting device is designed to use the patient’s […]

Filed Under: Featured, Food & Drug Administration (FDA), Pre-Market Approval (PMA), Regenerative Medicine, Regulatory/Compliance Tagged With: avitamedical

  • Go to page 1
  • Go to page 2
  • Go to page 3
  • Interim pages omitted …
  • Go to page 5
  • Go to Next Page »

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