Most medical device executives are reluctant to say anything that could in any way be construed as critical of the FDA or the agencies that determine reimbursement coverage decision. But not Robert "Skip" Cummins, president and CEO of neurostimulation pioneer Cyberonics. For the past two years, Cummins has been waging what has been a virtual one-man war with the FDA and major payers to make sure that psychiatrists and their patients have access to the only FDA-approved treatment for severe treatment resistant depression.
By David Cassak
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Good medical device regulation brings balance and builds bridges between healthcare stakeholders. It also accords equal priority to innovation and patient safety. A zero-risk policy cannot achieve these goals, says Christina Ziegenberg, BVMed’s head of regulatory affairs of six years.
Ochre Bio co-founder and CSO Quin Wills spoke with In Vivo about the UK-based company's novel approach to finding RNA therapies for chronic liver disease.
As GLP-1 agonists surge to blockbuster status transforming diabetes and obesity treatment, Richard DiMarchi, the pioneering scientist behind their development, recounts the inside story of the drug class in a fireside chat.
João Ribas combines scientific expertise with venture capital at Novo Holdings, applying his dual background to develop biotech investments that connect academic research with commercial opportunity.
