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OTC Devices

HBW US People News: CHPA Career Award, McGuffin Fund, Tobin, Therabody, Wild And Whoop

P&G veteran earns CHPA’s Career Achievement award; AHPA launches McGuffin Endowment Fund; Buffalo Bills QB Allen advises, promotes Therabody; tennis star serves Wild “Champions” campaign; Whoop gets entertainer’s endorsement, investment; and Tobin Scientific fills quality/regulatory SVP post.

Oura Gets Smart Ring Competitors Banned From US, But Faces Ultrahuman Countersuit

The US International Trade Commission has banned smart rings from Ultrahuman and RingConn after Oura Health's patent infringement case. Ultrahuman countersued, claiming Oura infringes its intellectual property. Sales and marketing of the affected rings will cease on October 22.

US Consumer Health People News: AHPA, CHPA, CRN, NPA, Armorgenix, Viatris

AHPA CEO Rigby speaks at SoCal Consortium; CRN announces keynote speakers for St. Louis conference; FDA consumer health office chiefs on CHPA’s RS&Q agenda; NPA has VP For communications, regulatory affairs; COO appointed for Armorgenix; and Viatris consolidates digital, cultural, structural transfo

Dexcom Nabs Weight Management Indication For Signos CGM

Signos links users to Dexcom’s Stelo for glucose readings and historic trends. The app is available in iOS and Android from the firm’s website, where it’s priced at $139 for three-month plan and $129 for a two-month plan, or online app stores.

Signos First Among US OTC Glucose Monitoring Systems To Offer Weight Management

Signos links users to Dexcom’s Stelo for glucose readings and historic trends. The app is available in iOS and Android from the firm’s website, where it’s priced at $139 for three-month plan and $129 for a two-month plan, or online app stores.

US FDA Maintaining Approval Output Despite Losing Staff

Reviewers were not targeted by the FDA reduction in force, but increasing attrition and difficulties hiring new staff still do not seem to have impacted new and generic drug approval totals.

FDA Warns Whoop BPI App Is Unauthorized Device; Firm Says Wearable Is A Wellness Tool

Recent FDA warning letter claims Boston firm specializing in wearable technology marketed a blood pressure device without agency approval, but the company rejects the assertion and says the agency is out of step with federal regulations.

Remote Regulatory Assessments Become Swiss Army Knife For US FDA’s Oversight Of Facilities

“RRAs are valuable oversight tools and under certain circumstances, can assist FDA in its mission to protect public health, oversee regulated industry, and help ensure regulated products comply with FDA requirements,” according to final guidance.

NAD Asks FTC To Pull Bandage Off Firm’s Plan To Exhaust Inventory Using ‘2X Faster Healing’ Claim

After National Advertising Division attorneys, in a review prompted by a challenge by Band-Aid line marketer Kenvue, recommended ASO LLV cease use of its “up to 2x faster healing” claim, they determined the firm had not fully complied.

US Consumer Health Market People News: CHPA Foundation Contest, Celsius And AdvoCare Hires

CHPA Health In Hand Foundation accepting nominations for 2025 US Self-Care Marketing Awards; Celsius hires former PepsiCo as president/COO and closes $1.8bn acquisition of energy drink competitor Alani; and AdvoCare adds John Peirano as integrated marketing VP after hiring Kathy Blosser supply chain VP.

Congress, Researchers Highlight Security Risks At DNA Testing Services

Congress launched an inquiry into 23andMe amid privacy concerns following its bankruptcy, particularly regarding the potential sale of sensitive user data. Additionally, a Cybernews report gave 40 DNA testing firms an average cybersecurity grade of D, citing widespread vulnerabilities and data breaches, along with inadequate public information about their security practices.

Roar Of Eargo-hearX Merger Echoes Through US OTC Hearing Aid Market

The firms recently announced they will operate as combined company LXE Hearing marketing Eargo’s namesake line and hearX’s Lexie brands. Eargo majority owner Patient Square Capital added $100m to its investment.