HeartSine Technologies LLC
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The number of 510(k) clearances in January by US FDA were lower than average, but there was at least one practice-changing advance deemed substantially equivalent last month: Roche's high-sensitivity Elecsys cardiac troponin assay. There were four original PMAs approved in January, but a lower-than-usual total of supplement approvals.
Derived from Strategic Transactions, Informa’s premium source for tracking life sciences deal activity, the Dealmaking column is a survey of recent health care transactions listed by relevant industry segment – In Vitro Diagnostics, Medical Devices, Pharmaceuticals, and Research/Analytical Tools – and then categorized by type – Acquisition, Alliance, or Financing. This month’s column covers deals announced in September 2015.
Derived from Strategic Transactions, Informa’s premium source for tracking life sciences deal activity, the Medical Device Deals Update column is a survey of recent medtech M&A, alliance, and financing activity. This month’s column covers deals announced August-September 2015.
Fifty-six class I recalls were publicized by FDA in calendar year 2012; manufacturers CareFusion and General Electric led the pack with seven class I’s apiece.