OTC Devices

This week, two device testing labs in China landed FDA warning letters; refunds for 1Health.io clients; FDA AR/VR product list expands. 

Apple is introducing new health features in conjunction with its launch of the Series 10 Apple Watch and AirPods Pro 2 earbuds, which soon will be able to monitor for potential sleep apnea and function as a clinical-grade hearing aid, respectively, pending regulatory clearances in the US and other countries around the globe.

Weak demand for virus-blocking nasal sprays since the pandemic has left Austrian biotech Marinomed with mounting debts. The company has applied for restructuring proceedings with an Austrian court in an attempt to secure its future.

The US FDA has granted marketing authorization to NOWDiagnostics for the first at-home over-the-counter test to detect syphilis, which the government says is on the rise.

Amulet announces $5.8 million in series A financing led by HealthX Ventures along with Incite Ventures, AllerFund, Mendota Venture Capital and Great Oaks Venture Capital. Allergy Amulet is for on-the-go testing of food to determine whether allergens are present.

A bipartisan bill now in the US Senate seeks to change the classification of implantable hearing aid devices to allow Medicare to reimburse for the devices, potentially expanding access for many Americans who require them.

Just under a third of UK parents who smoke or have smoked in the past believe there isn’t enough support to quit, and nearly a quarter don’t know where to go for support, Kenvue reports, based on recent surveys. In response, the firm launches the “Smokefree Families” initiative to help the 1.8m households in England with children and at least one smoker to become smoke free. 

A recently-published study funded by the UK National Institute for Health and Care Research finds that use of OTC nasal sprays reduces overall respiratory illness duration by about a fifth. Applied at a population level, self-care could therefore save billions in healthcare and human capital costs, as industry has pointed out elsewhere, as well as redirecting people away from antibiotic treatments that are still widely misprescribed, contributing to the fight against antimicrobial resistance. 

Warning letters to SuXiang Medical Instrument in China and Yahon Enterprise in Vietnam among recent warnings FDAS sent to OTC drug and supplement manufacturers, including a Florida firm, White Label Leaf, warned about selling gummies containing delta-8 THC, and other OTC skin care product firms.

Zengence, the first virtual reality game intended to help reduce stress, became available earlier this summer. We talked to DeepWell DTx founder Ryan Douglas about the road ahead.

The Series B funding round led by DigitalDx Ventures will support development and commercialization of more than 30 rapid diagnostic tests in NOWDx’s clinical research pipeline, including its First To Know Syphilis OTC test, currently under US FDA De Novo review, which provides at-home results in minutes.

More than a year after the FDA created a new rule allowing hearing aids to be sold over the counter and directly to consumers, a government report finds the category has not yet made the impact many were expecting.

Aspirin is celebrating its 125th anniversary this year. To find out what brand owner Bayer Consumer Health is doing to celebrate this occasion, and what it is doing to take the brand into the next 125 years, HBW Insight chats with the company’s senior vice president, Global Head Allergy, Cough/Cold, Pain and Heart Health, Reese Fitzpatrick, and head of R&D, North America and Therapeutics, Rachel Koontz.

UK medical devices manufacturer Owen Mumford moves into consumer health with umbrella brand Clariti and OTC relaunch of at-home vaginismus and dyspareunia treatment Amielle Comfort.

France, Italy and Spain among the 10 countries where Futura Medical has rolled out its Eroxon drug-free erectile dysfunction treatment in the opening six months of the year.

When it comes to online consumer health product advertising, complying with regulations, ensuring that content is factually correct and being transparent are some of the key principles that companies should adhere to, recommends AESGP in a recently published position paper. 

UK medical devices manufacturer Owen Mumford moves into consumer health with umbrella brand Clariti and OTC relaunch of at-home vaginismus and dyspareunia treatment Amielle Comfort.

More than a year after the FDA created a new rule allowing hearing aids to be sold over the counter and directly to consumers, a government report finds the category has not yet made the impact many were expecting.

Failing to take sufficient action on climate change could be a costly business for consumer health companies. However, the good news from the AESGP's 60th Annual Meeting in Brussels, Belgium, is that at least half of the cost of decarbonizing will be balanced by savings, according to Boston Consulting Group. And climate change adaption will present firms with a wide variety of opportunities for product innovation, IQVIA Consumer Health's Volker Spitzer tells delegates.

The US FDA has issued a final rule allowing the agency to destroy some medical devices that have been refused entry into the US. The rule takes effect 1 July.