Nasdaq

InnerScope Hearing Technologies (OTC: INND) Completes FDA Class II Medical Device Registration for its Hearing Aid Devices

InnerScope has completed the FDA Medical Device Registration for Class II Hearing Aid, Air Conduction with Wireless Technology, and is preparing for the Launch of its Latest in Direct-to-Consumer ...
News Medical

Medical Device Categories Explained

The U.S. Food and Drug Administration (FDA) categorizes medical devices into three classes based on the level of risk the devices pose to patients and users. Image Credit: IGORdeyka/Shutterstock.com ...
Becker's Hospital Review

Bacteria-resistant scrubs designated Class II medical device by FDA

Vestagen Protective Technologies, a developer of healthcare worker uniforms and scrubs, received FDA clearance as a Class II medical device for its Vestex apparel — the first daily-wear scrubs to ...
Business Wire

Tasso+™ Device Earns FDA 510(k) Class II Medical Device Clearance

SEATTLE--(BUSINESS WIRE)--Tasso, Inc., the leading provider of convenient, clinical-grade blood collection solutions, today announced that the U.S. Food and Drug Administration (FDA) has cleared its ...
Nasdaq

Cell MedX Corp.'s eBalance Home System Receives Class II Medical Device License from Health Canada

The eBalance Home System is a non-invasive, fully automated microcurrent electrotherapy system that administers pre-programmed algorithms through the epidermis with the touch of a button. The eBalance ...
JD Supra

Unpacking Averages: How Accurate Do Class II Medical Devices Need to Be to Obtain 510(k) Clearance?

It’s common for a client to show up at my door and explain that they have performance data on a medical device they have been testing, and for the client to ask me if the performance they found is ...
Gizmochina

Xiaomi to launch its first Blood Pressure Smartwatch with Class II medical device certification on Oct 26

According to the teased image, this smartwatch will feature a round dial with a sleek, non-bulky design and two physical buttons on the right side. The strap seems sturdy and is expected to include ...
AppleInsider

Apple job listing hints at work on Class II medical device

Apple is looking to hire a regulatory project manager that will help the company develop a Class II medical device or feature likely related to the Apple Watch or iPhone. The project manager will work ...
MobiHealthNews

FDA to Opternative: Online eye exams are a Class 2 device

Opternative, a Chicago-based purveyor of online and mobile refractive eye exams, received a warning letter from the FDA last fall. The October 30 warning letter was only recently made public by the ...
Nextgov

FDA Set to Issue Final Rule Classifying VR Therapy Device for Pain Relief

Get the latest federal technology news delivered to your inbox. The Food and Drug Administration is set to publish a final rule in the Federal Register on Friday that would formally classify a new ...
Business Insider

InnerScope Hearing Technologies (OTC: INND) Completes FDA Class II Medical Device Registration for its Hearing Aid Devices

ROSEVILLE, Calif., March 3, 2021 /PRNewswire/ -- InnerScope Hearing Technologies Inc. (OTC: INND) ("InnerScope") announced today it has completed and updated the FDA Medical Device Registration for ...