FDA granted de novo clearance to Curetis' Unyvero "sample-to-answer" diagnostic system and the Lower Respiratory Tract Infection Application Cartridge, the company announced April 3. Unyvero works with the Unyvero LRT Application Cartridge to provides rapid infectious disease testing directly from aspirate samples in less than five hours. The FDA decision comes a day after the Singapore Health Sciences Authority approved Curetis' Unyvero BCU Cartridge.

At $1.2 billion, Q4 device financing was the second-lowest quarter of 2015; M&A dollar volume was also low, but included multiple deals across various cardiovascular markets. Diagnostics financing was also down in Q4, totaling $403 million; acquisitions were worth $441 million.

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, and Pharmaceuticals – and then categorized by type – Acquisition, Alliance, or Financing. This month’s column covers deals announced 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 September-October 2015.