Dental Oral

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.

In its physician fee schedule for 2023, US Medicare seeks to expand access to mental health services and overall care to patients in rural and underserved communities.

An internal investigation found that the company’s leadership may have directed employees to improperly account for sales-incentive payments. As a result, the company has been unable to file its quarterly report for the first quarter of 2022 with the SEC.

The US FDA says in a pair of final guidance documents that makers of the resins and screw systems don’t have to compare their devices to already-marketed products when submitting a 510(k) to the agency for review.

Products Iotech International sells to health care providers and consumers are deemed unapproved new drugs and are misbranded due to claims to prevent and treat COVID-19. ACON Laboratories determined Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) is for sale in US without approval.

Colgate Optic White line with Pro Series teeth-whitening toothpaste contains 5% hydrogen peroxide; P&G’s Crest Whitening Emulsions + Overnight Freshness offers convenience of overnight use.

“I think we would view a lot of this inflation as structural,” says John Faucher, Colgate’s mergers and acquisitions and investor relations chief.

Colgate expects countries where oral care isn’t a daily habit per capita are biggest opportunities for growth. Half its sales growth is in e-commerce and other channels that don't show up in market data.

In this edition of Device Week, Medtech Insight’s Barnaby Pickering discusses Zimmer Biomet’s recent spin-off of its spinal and dental businesses under the name ZimVie and editor Marion Webb explains the emerging field of femtech, which includes innovations to treat often-overlooked unmet needs in women’s health

The share price for ZimVie, Zimmer Biomet’s spinal and dental spin-off company, dropped following its launch on NASDAQ.

NARB panel concluded #1 claims challenged by Oral-B floss products marketer P&G aren’t supported by acceptable evidence that the type of product the claim referenced – flossers  – “is recognized as a consumer-relevant category."

NAD says “equivalized” sales data Perrigo submitted to support claim didn’t provide an accurate measure of flosser product category; instead, “un-equivalized” data P&G submitted were accurate measure. Perrigo counters that the decision conflated separate product categories as well as dismissed appropriate data.

The company also named ZimVie’s management team, led by CEO Vafa Jamali.

Hisamitsu America launches online portal exclusively for health care professionals. Also in OTC topical space, Beutlich Pharmaceuticals extends HurriCaine benzocaine gel and spray line with oral anesthetic single-dose packages in five flavors.

Higher material and packaging costs in North America drove Colgate’s Q2 operating profit down 21%. Oral care sales were the bright spot in an otherwise difficult quarter in North America, where total sales declined 4% due to COVID-related demand in 2020 and competitive pressure.