US FDA Clearance For Masimo’s Stork Wakes Up OTC Baby Monitoring Technology Competition

Masimo receives US regulatory clearance for Stork OTC baby monitoring system six months after Owlet received first clearance for its Dream Sock following a regulatory stumble which halted sales of a previous device, Smart Sock, in 2021.

• Source: Shutterstock

Masimo Corp. has received US regulatory clearance for its Stork OTC baby monitoring system six months after a competitor pioneered the market following its regulatory stumble which halted sales of a previous device in 2021.

Masimo on 6 May said OTC Stork is made with the same pulse oximetry technology that is used in its...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on HBW Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Business

Trump’s Latest Tariff Order Reheats Consumer Worries And Price Increases In Healthcare Sector

 

When consumer health and beauty firms announce results for current quarter, they likely will note trend many reported after first quarter, an uptick in revenues and volume due to consumer concern about Trump’s tariffs gambit leading to higher product prices.

GSCF: ‘No One Size Fits All’ Solution To Tricky Sustainable Blister Pack Challenge

 
• By 

A series of research papers recently published by the Global Self-Care Federation indicate that industry will need to be pragmatic about alternatives to PVC in medicine blister packs.

Moberg Has US Ambitions For Novel Nail Fungus Treatment

 
• By 

Sweden's Moberg wants to introduce its onychomycosis treatment to the US but expects it will need to complete an additional study to win FDA approval.

People On The Move: Appointments At Enzymatica, Haleon, Futura

 
• By 

A round up of the latest moves in Europe's consumer health market: Enzymatica appoints CEO; Haleon hires DACH marketing chief; Futura confirms interim CEO.

More from Health

Moberg Has US Ambitions For Novel Nail Fungus Treatment

 
• By 

Sweden's Moberg wants to introduce its onychomycosis treatment to the US but expects it will need to complete an additional study to win FDA approval.

Maternal Nutrition, Contraceptive Innovation Among Gates Foundation’s Latest Research Goals

 

“Women’s health continues to be ignored, underfunded, and sidelined. Too many women still die from preventable causes or live in poor health. That must change,” says Bill Gates.

New US FDA Chief Counsel More Familiar With Trump World Than Food and Drug Law

 

Sean Keveney is largely unknown in the FDA law space, but likely is familiar and connected to the White House given his work on Trump’s antisemitism taskforce.