Medtech manufacturers may soon have clearer guidelines on how to get their products through the FDA’s 510(k) process—with the changes meant to address the widespread criticism of the regulatory pathway in recent years by ...
Tensys Medical has obtained State Food & Drug Administration (SFDA) approval for its new continuous, non-invasive hemodynamic patient monitoring system in the People’s Republic of China. The TL-300 T-Line system comprises of a ...
Tags: SFDA Approval, Tensys Medical
Texas Instruments (TI) has introduced Li-Ion battery fuel gauge integrated circuit, called the bq27421, which improves battery run-time in portable medical devices. Using TI's proven Impedance Track advanced battery technology, the ...
Zhejiang Shanshi Medical Device (Shanshi) has signed a commercial agreement with Tensys Medical, a developer of continuous, non-invasive hemodynamic patient monitoring systems. Under the agreement, Shanshi has gained rights to market ...
Tags: Shanshi, Tensys Medical, hemodynamic patient monitoring systems
Tensys Medical's new continuous, non-invasive hemodynamic patient monitoring system has obtained 510(k) clearance from the US Food and Drug Administration (FDA). The TL-300 system, a member of T-Line family, is designed for use in ...
Tags: Hemodynamic Patient Monitor, FDA Approval, TL-300 system
Spacelabs Healthcare, a subsidiary of OSI Systems, has obtained 510(k) approval for its new compact, sidestream gas analyzer, Capnography Pod, from the US Food and Drug Administration (FDA). Capnography Pod, which is compatible with the ...
Tags: Spacelabs, OSI Systems, approval, FDA
Spacelabs Healthcare, a division of OSI Systems, has won $3m contract from two hospitals in the Southeast region for patient monitoring solutions. Under the contract, Spacelabs will provide its patient monitoring systems including ...
Tags: Spacelabs Healthcare, OSI Systems, patient monitoring solutions
Continuum has received seven International Design Excellence Awards(IDEA)from the Industrial Design Society of America(IDSA).The IDEAs were awarded to Continuum for the company's work with Mindray,the Herman Miller Compass system,Daktari ...