Spectral Gets 510(k) Clearance From FDA

Spectral Medical (TSX:EDT) announced the United States Food and Drug Administration (FDA) granted 510(k) clearance for their Spectral Apheresis Machine (SAM) used in continuous renal replacement therapy and therapeutic plasma exchange.
As quoted in the press release:

The Company has also submitted final documentation seeking approval of SAM from Health Canada and anticipates a decision in the first half of 2018.
SAM was initially developed with the intent of supporting the potential commercialization of Toraymyxin ™ (“PMX”), whereby intensive care units could use SAM to efficiently and safely deliver the PMX treatment to septic shock patients and not rely on third party CRRT machines. The regulatory path led the Company to first seek 510(k) clearance of SAM for CRRT applications, which has now been achieved. SAM has also been designed as an open platform hemoperfusion delivery device and the Company intends to seek further 510(k) clearance for this purpose when there is an FDA approved hemoperfusion cartridge available for use in the US market, including potentially Spectral’s PMX treatment.

Click here to read the full press release.

Source: www.marketwired.com