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News We’re Watching: Free COVID-19 Tests, Edwards Antitrust Investigation, McKinsey Calls For Medtech ‘Reinvention’

 
• By Brian Bossetta and Reed Miller

This week, the US government relaunched a program providing free COVID-19 tests and invested $600m in domestic test manufacturing; the European Commission revealed an antitrust investigation of Edwards LifeSciences; and a consulting firm report said the medtech industry should make big changes to address investor skepticism.

"News We're Watching" Feature Image
• Source: Medtech Insight

With COVID-19 cases ticking back up, the Biden administration is restarting a program that allows Americans to get four rapid tests in the mail at no charge. The tests can be ordered now at COVID.gov and will be delivered by the US Postal Service beginning 2 October.

Along with announcing the program’s relaunch, the administration also

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Regeneron Sees 23andMe Buy As Complement To Genetics Platform - Clone

 
• By Alaric DeArment

The consumer genomics firm will operate as a subsidiary, while Regeneron plans to leverage its database for drug discovery and trial design efforts.

Disparities — Including Financials Shortcomings — Remain In Women’s Health, Execs Say

 
• By Brian Bossetta

FemTech leaders discussed some of the barriers that remain in unlocking the full potential of the women’s health market during SiS New York last week. They also offered solutions.

Mirvie Launches Predictive Blood Test For Preeclampsia

 
• By Marion Webb

Mirvie launched Encompass, a blood test to help identify women over age 35 who are at moderate risk for preeclampsia, and will conduct additional studies to support reimbursements from payers.

Bringing Israeli Medical Device Candidates To The Right Partners In The US

 
• By Ashley Yeo

Despite regional unrest, it is business as usual for medtech innovators and investors in Israel as evidenced by continued high-value M&A of locally developed technologies. Irit Yaniv, co-chair of the medtech session at the upcoming BioMed Israel 2025, explained the unique dynamics of Israeli medtech innovation.

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How Structured Patient Engagement Gives Medtech Companies A Competitive Edge

 
• By Amanda Maxwell

Communication with patients has become a particularly crucial factor for investors, payers, and other healthcare decision-makers in a hostile market environment.

Digital Health And AI Tools Advance Cardiac Event Prediction, SCAI 2025 Data Show

 
• By Shubham Singh

Out-of-hospital cardiac arrest remains one of the most challenging and resource-intensive emergencies in cardiovascular care. At SCAI 2025, clinicians presented a novel algorithm that improved triage decisions and reduced unnecessary interventions.

Debate On FDA User Fee Reauthorization Begins To Take Shape

 
• By Elizabeth Orr

A battle may be forming over the 2027 FDA user fee reauthorizations. At a conference Friday, Democratic Rep. Jake Auchincloss supports them for their effectiveness, while Deputy FDA Commissioner Grace Graham echoed criticisms from HHS Sec. Kennedy, among others, in calling for reform to ensure public trust.