Cala Health Hopes To Jolt Essential Tremor Market With Wrist-Worn Non-Invasive Stimulation

Cala Health’s FDA-cleared Cala Trio wearable for treating essential tremor is currently being tested in Parkinson’s disease patients and is targeting a $20bn global market opportunity.

Start-up Spotlight

This week, the Burlingame-based bioelectronic medicine company announced it received $77m in new funding, led by Ascension Ventures and new investors Dolby Family Ventures, Peak6 Strategic Capital, a division of PEAK6 Investments, and Innovatus Capital Partners. The company said it will use the new financing to expand patient access, accelerate innovation and explore indications including in Parkinson’s disease as well as psychiatry, cardiology and autoimmune disease.

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Whitaker Wants Congress To Capitalize On ‘Golden Age Of Medical Innovation’

AdvaMed’s top priorities for the 119th Congress include modernizing US Medicare services and expanding patients’ access to the latest medical technologies.

THENA Capital ‘Makes History’ As UK’s First All-Female Early-Stage Medtech Fund

 

Only 16% of venture capital general partners in Europe are women, and only 9% of those have actual investment power. Thena Capital is aiming to "redefine the image of a venture capitalist."

AI-Based Screening Tool For Musculoskeletal Issues Gets US FDA Warning Letter

 
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Exer Labs Inc.’s website marketed its AI-based Exer Scan app to “screen and treat Parkinson’s, TB, Cerebral Palsy and more.” But those claims went well beyond what was allowed under the product’s 510(k) clearance, US regulators say.

Wired Health: ‘Early Diagnosis Often Benefits Science But Not The Patient’

 

Early diagnosis can be “detrimental” to patients, Suzanne O'Sullivan, neurologist and author of “The Age of Diagnosis,” argued at the Wired Health conference on 18 March. "You save one life from screening 2,000 women for breast cancer, but you also treat 10 women unnecessarily," she said.

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US Could Lose Its First Approver Advantage After FDA Layoffs

Mass FDA layoffs on 1 April were designed to spare product reviewers, but still touched many who are critical to the application review process or drug development, which could mean fewer treatments are brought to the US market first.

Staff Cuts At CDRH Focus On Administrative Workers, Spare Reviewers

 

About 200 staff in the FDA’s Center for Devices and Radiological Health were among the 3,500 FDA employees let go in today’s staff reductions. The cuts, which one employee described as a “Manhattan Project” to the center, are already having a major effect on staff morale.

Global Medtech Guidance Tracker: March 2025

 
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Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.