Dental Oral

This week, Establishment Labs Holdings announced the FDA gave it premarket approval for Motiva breast implant, Cologuard lands FDA approval for Cologuard Plus and GE HealthCare gets FDA nod for a new imaging agent. The FDA announces another expansion for TAP into ophthalmology and radiology. The AAMI and CTA will join forces to develop standards for AI and ML-enabled health care products.  

Guidance documents issued 30 September explain how makers of air powered dental handpieces and air motors, dental cements, dental ceramics, and dental impression materials can bring their products to market by demonstrating compliance with established criteria, without a direct comparison to a predicate device.

The US FDA released six more device classifications in early September, including products from Edwards, Interscope, and Baxter Healthcare.

Laifen, Opalescence Moon, Lewie and quip are among US companies with recent launches to boost their oral care market shares. Recent launch by Arm & Hammer global oral care brand also targets driving growth in the category.

HiSmile appeals NAD recommendation following review on P&G challenge to discontinue ad claims on its website and in social media videos stating peroxide-containing whitening products are “painful” or cause pain, break down and impact gums and teeth, or “damage” gums.

While the latest missions from NASA may seem like the stuff of science fiction, discoveries from outer space are not only unlocking the mysteries of the cosmos, but improving technologies used every day on Earth, including those in the medtech industry.

National Advertising Division recommends Oral Essentials discontinue  claims on packaging that Lumineux strips are "first on the market that are delicious and clinically proven to whiten teeth as well as the leading brand, without the harm associated with bleaches.”

The US FDA has issued final guidance to assist developers in preparing various applications for medical devices that come in contact with the human body. The guidance also seeks to clarify the use of international standards in assessing device biocompatibility.

National Advertising Division decision, on challenge by P&G, is another lesson for advertisers not to expect highlighting differences between products establishes theirs as better or more effective than competitors’ products.

The company’s health businesses include product lines worth nearly $9bn in annual sales. The deal is designed to allow both the new health care company and the “new 3M” to focus resources more efficiently on their separate priorities.