A new player is taking a step toward the regulatory approved medical device market in the US.
On Tuesday, Australian hearing aid firm Nuheara has announced that it has submitted a 510(k) registration with the US Food and Drug Administration (FDA) for its self-fitting hearing aid, a press release reports.
Already a subscriber? Log in.
Read the whole article
Get access for 14 days for free.
No credit card is needed, and you will not be automatically signed up for a paid subscription after the free trial.
- Access all locked articles
- Receive our daily newsletters
- Access our app
Get full access for you and your coworkers.
Start a free company trial todayMore from MedWatch
Long wait for IVDR implementation is over, putting an end to pandemic "wild west"
After prolonged debates on potential bottlenecking and supply issues, the EU’s long-awaited In Vitro Diagnostic Medical Devices Regulation comes into force on May 26.
GN purchase story is very speculative, says analyst
Competition rules could block a purchase of GN Store Nord and subsequent divestment of GN Hearing, says a Sydbank analyst on the speculative story that this might be underway.
Bavarian Nordic upgrades guidance following vaccine contract
Bavarian has been the center of attention in recent days due to its monkeypox vaccine, and the company has now secured a vaccine contract with another undisclosed country. Consequently, Bavarian has raised its expectations for the full year.
Novo Nordisk invests additional millions of dollars in new manufacturing facilities
Novo Nordisk’s DKK 17bn (USD 2.4bn) investment into upgrading and building new facilities in Kalundborg last year has now been followed by a DKK 1bn (USD 143.8m) investment in the same location.
US to start using Bavarian vaccine stockpile
In an attempt to contain a monkeypox outbreak, US authorities will start offering certain people Bavarian Nordic-developed Jynneos vaccinations against the infectious disease.
Director Global Engineering 
System Sales Development Consultant - Investment Projects, Merck Millipore 
Senior IT Network Engineer 
Project Manager & Scrum Master 
Nordic Medical Affairs Manager 
Innovation Project Manager, Display Unit 
Senior Project Manager (GMP - Life Science) 
Senior QA Specialist 
(Senior) Drug Substance Specialist 
Production Director 
KLIFO is looking for a Clinical Supply Manager for our Glostrup office 
IRT Manager, Clinical Drug Supply 
2 Sales Representatives and Product Specialists 
Key Account Manager, Europe and Asia 
Clinical Trial Manager 
Director for innovative pre-clinical testing unit 
Cell Culture Scientist/Senior Scientist 
Account Manager