Pear CEO Sees Fulfilment And Reimbursement Challenges Ahead

Medtech Insight spoke to Pear Therapeutics CEO Corey McMann about the emerging digital therapeutics market and his company’s future now that it has the first PDT covered by Medicaid.

• Source: Alamy

Among the most significant changes in health care during the pandemic has been the acceptance of digital therapeutics that may transform care pathways.

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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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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.

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.