Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Averra, Iridex, Mellingmedical, Nitinotes, Novogene, Photosound Technologies, Ratio Therapeutics, Siemens Medical Solutions, Terrapower, Trinity Biotech, Verasonics, Vivasure Medical, Zien Medical Technologies, Zynex.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Edwards, Tissium.
Using informed consent to do what Congress couldn’t, the U.S. FDA is flexing its regulatory authority to halt clinical trials that involve sending cells from American patients to China or other adversarial nations for genetic engineering and subsequent infusion back into the patient.
“I expressed deep concerns with your nomination, Secretary Kennedy, and somehow, unfortunately, you have exceeded my expectations in the worst possible ways,” U.S. Rep. Frank Pallone, D-N.J., told Health and Human Services (HHS) Secretary Robert Kennedy during a June 24 House subcommittee hearing.
The Medicare Payment Advisory Commission advised Congress that inflation is taking a bite out of physician pay and Medicare payments may have to increase in order to preserve patient access to care.
In a bid to boost its multiomics holdings, Illumina Inc. reported an agreement to buy proteomics technology company Somalogic Inc. from Standard Biotools Inc. for $350 million in cash, plus up to $75 million in near-term performance-based milestones and performance-based royalties.
At the American Diabetes Association 85th Scientific Sessions in Chicago June 20-23, Fractyl Health Inc. presented results from two studies evaluating very different approaches to treating – and possibly curing – type 2 diabetes.
Bioprosthetic heart maker Carmat SA shares collapsed on June 23, reaching €0.28 on the Paris Stock Exchange after the company announced it would run out of cash by the end of the month without immediate financial support.
Deepecho Inc. received the U.S. FDA’s nod for its AI-based platform that assesses fetal biometry and amniotic fluid volume to improve the efficiency and precision of fetal ultrasound diagnostics.
The U.K. Medicines and Healthcare Products Regulatory Agency opened a second round in its AI airlock program although this round, like the first round, will be limited to four applicants.
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