HeartSine Technologies LLC
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Latest From HeartSine Technologies LLC
US Approvals Analysis: Slow 510(k) Month Includes Major Cardiac Assay Clearance
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.
Deals Shaping The Medical Industry, October 2015
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.
Medical Device Deals Update, October 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.
2012 Class I Recalls
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.
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