Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Atreon Orthopedics, Cerus, Medrhythms, Qiagen.
Jay Bhattacharya will have his work cut out for him if he wins confirmation as the next director of the U.S. NIH. Besides getting NIH committees back on track to evaluate grant applications and calming the fears of researchers and other staff who have seen about 1,200 colleagues cut from their ranks in recent weeks, Bhattacharya will face the task of rebuilding public trust in the NIH itself.
Ajax Health LLC, with backing from the $4 billion KKR Health Care Strategic Growth Fund II, and Boston Scientific Corp. launched a new business, Flowmod, to advance a system for treating heart failure developed by Boston Sci.
The widespread need for cartilage repair may have bred optimism on the part of Spinalcyte LLC when it filed a related patent in 2014, but the Patent Trial and Appeal Board has affirmed a rejection of the patent due to lack of enablement, an object lesson regarding the need for clarity in patent applications.
The U.S. FDA drafted a guidance for clinical trials for evaluation of optical imaging (OI) agents. The policy may allow clinical studies to evaluate an OI agent by means of an intrasubject study design, which would save time and money for the sponsor.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aiforia, Atomic Alchemy, Hip Innovation, Oklo, Orion, Sanuwave.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Spark Biomedical.
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