Start-Up News
Executive Summary
Noteworthy news from medtech start-ups. This month we profile CardioPolymers Inc., which is developing a highly purified form of seaweed that, when implanted into the heart, has the potential to stop or even reverse the progression of congestive heart failure. We also profile Aura Medsystems, which is developing photodynamic soft-tissue repair technology.
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US FDA Oncology, Device Centers Developing Public Diagnostic Standards
Pilot program would get around the ‘one drug, one test’ policy, which has created intellectual property issues.
Valisure’s Benzene Testing Challenged By PCPC; FDA Focus Should Be Raw Materials, Trade Group Says
On roughly the 1-year anniversary of Valisure’s citizen petition to the FDA regarding benzene detected in body sprays, the Personal Care Products Council weighs in on the matter.
CSL’s Hemgenix Gene Therapy Does Not Need A REMS, FDA Tells National Hemophilia Foundation
Peter Marks says labeling for CSL’s hemophilia B treatment adequately conveys its risks. He also denies NHF request that the label cite eligibility criteria used in clinical trials, responding to a citizen petition on the day the agency approves the therapy.