Quickly uncover the breadth and depth of the editorial offerings found only in MedTech Strategist and Market Pathways – the medtech industry’s leading sources of global business, regulatory, and reimbursement analysis and intelligence on an all-in-one, digital platform. Think Strategically. Subscribe Today
Former leaders of CDRH want to take the thinking behind the device center's TAP program into the venture capital world. Longtime center director Jeff Shuren is joining former CDRH Chief Scientist Douglas Kelly and others to launch White Oak 66 Capital, seeking to combine medtech investing with a heavy focus on helping firms proactively address reimbursement and other post-FDA commercialization risks.
While diuretics act directly on the fluid-overloaded vascular compartment, WhiteSwell believes that during episodes of ADHF, to effectively restore balance, interstitial fluid must be moved out of the congested tissues. The start-up plans to accomplish this with a device called the eLym System, now being studied in a multicenter, prospective single-arm study called DELTA-HF. A companion article to "Innovating Heart Failure: Start-Ups Harness Natural Pathways."
Digital device approvals are way up from last year. Excerpted from Pathways' Picks March 11: CDRH Hiring Push, UK Taps Former FDAer, Global Policy Updates.