Becker's Hospital Review

Unique device identifiers required for class II medical devices this fall

Starting in September, class II medical devices will be required to be equipped with a unique device identifier to be in compliance with UDI regulations. The U.S. Food and Drug Administration passed ...
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 ...
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 ...
MD&M East

FDA Reclassifies Surgical Staplers and Staples

On Oct 7, 2021, FDA issued a guidance on surgical staplers and staples for internal use, reclassifying them from Class I (general controls) to Class II (special controls) devices and requiring them 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 ...
Business Wire

Nortech Systems Suzhou Facility Certified to Produce Class II Medical Devices for Asia Market

MINNEAPOLIS--(BUSINESS WIRE)--Nortech Systems Incorporated (Nasdaq: NSYS) (the "Company"), a leading provider of engineering and manufacturing solutions for complex electromedical and ...
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 ...
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 ...
JD Supra

FDA Reverses HHS Exemption of Class I and Class II Medical Devices from Section 510(k)

Premarket Notification Again Required for Patient and Surgeon's Examination Gloves and Dozens of Class II Devices Proposed for Exemption by Former HHS Secretary JANUARY 15 HHS NOTICE RECONSIDERED BY ...
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 ...
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 ...