CVR Med­i­cal sub­mits CSS to TUV Rhein­land for test­ing

Stockwatch Daily - - HEALTH CARE - Mr. Peter Bakema re­ports

CVR MED­I­CAL Corp. has sub­mit­ted the carotid stenotic scan (CSS) to TUV Rhein­land for elec­tri­cal safety and EMC test­ing. TUV Rhein­land is one of the lead­ing providers of prod­uct safety cer­ti­fi­ca­tions world­wide, cov­er­ing an as­sort­ment o f items suc h as med­i­cal de­vices, home ap­pli­ances, au­dio/video prod­ucts, med­i­cal prod­ucts, tex­tiles and telecom­mu­ni­ca­tion equip­ment. This test­ing is re­quired for the CSS’s sub­se­quent De Novo sub­mis­sion to the Food and Drug Ad­min­is­tra­tion for United States mar­ket clear­ance and will show that the de­vice is com­pli­ant with all IEC 60601-1 re­quire­ments. IEC 60601 is a se­ries of tech­ni­cal stan­dards for the safety and es­sen­tial per­for­mance of med­i­cal elec­tri­cal equip­ment, pub­lished by the In­ter­na­tional Elec­trotech­ni­cal Com­mis­sion. First pub­lished in 1977 and reg­u­larly up­dated and re­struc­tured, IEC 60601-1 is widely ac­cepted as the bench­mark for elec­tronic med­i­cal equip­ment.

Tony Robinson, CVR Med­i­cal’s chief op­er­at­ing of­fi­cer, com­mented: “It feels good to have the CSS in the hands of TUV and pro­gress­ing through one of the crit­i­cal fi­nal steps nec­es­sary for our FDA sub­mis­sion. With the up­com­ing tran­si­tion from IEC 60601-1 third edi­tion to fourth edi­tion, a change which the CSS was al­ready de­signed in com­pli­ance with the queue to get de­vices into TUV sub­stan­tially length­ened, ex­ceed­ing what we orig­i­nally al­lo­cated for an in­tended Oc­to­ber FDA sub­mis­sion. This is push­ing our time­line fur­ther back, but I have com­plete con­fi­dence in the en­gi­neers at CVR and the qual­ity of the prod­uct they de­signed. With their fo­cus on de­vel­op­ing a prod­uct that is first and fore­most safe, I be­lieve that we will progress smoothly through the TUV test­ing sched­ule with­out de­lay. With the ma­jor­ity of our De Novo doc­u­men­ta­tion fi­nal­ized and cur­rent clin­i­cal trial num­bers ex­ceed­ing the re­quire­ments an­tic­i­pated by our in­dus­try-lead­ing reg­u­la­tory con­sul­tants, we are still tar­get­ing an end of Q4 sub­mis­sion. How­ever, this is con­tin­gent on ex­ter­nal forces and is out of CVR’s con­trol, though all key stake­hold­ers are work­ing tire­lessly to ex­pe­dite the process. CVR also an­nounces the in­ten­tion to sub­mit to Health Canada for a Cana­dian med­i­cal de­vice li­cence (MDL), which would pro­vide ap­proval for sales of the CSS into Canada, forth­with upon sub­mit­ting to the FDA for mar­ket clear­ance. Ob­tain­ing the abil­ity to dis­trib­ute the CSS into Canada would open up one of the largest global economies, with di­ag­nos­tic imag­ing rep­re­sent­ing 21 per cent of their $6.7-bil­lion med­i­cal de­vice mar­ket. Peter Bakema, chief ex­ec­u­tive of­fi­cer and board chair­man, elab­o­rates on the de­ci­sion to launch into Canada in the near term: “It only makes sense that we con­tinue our mo­men­tum with sub­mit­ting to the FDA, lev­er­ag­ing both re­la­tional and geo­graphic ad­van­tages. With the sub­mis­sion re­quire­ments mir­ror­ing most of the EU Tech­ni­cal dossier, we will be able to ad­vance the pace of global avail­abil­ity.” About CVR Med­i­cal Corp. CVR Med­i­cal is a health care com­pany that op­er­ates in the med­i­cal de­vice in­dus­try fo­cused on the com­mer­cial­iza­tion of its dis­rup­tive, pro­pri­etary CSS de­vice. CVR Med­i­cal is cur­rently in piv­otal clin­i­cal tri­als in prepa­ra­tion for its planned sub­mis­sion to the U.S. Food and Drug Ad­min­is­tra­tion.

We seek Safe Har­bor.

Ron­nie Floyd Birch, Paul S Blun­den, Bruno Chris­tian Fr­us­calzo, Dal­las C Hack, Wayne Hell­man, Dou­glas Weaver

(CVM) Shares: 77,637,578

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