Medical network May 19 - on May 17th, administration of drug safety device whose center released 2017 4, review the results of the public, to agree to 7 products to the innovation of medical equipment special approval process.
Include:
Product name: low temperature plasma operating system
Applicant: Beijing nortes technology co., LTD
Product name: quantitative blood flow score measurement system
Applicant: bo mobile medical imaging technology (Shanghai) co., LTD
Product name: adsorbed blood dialysis system
Applicant: medtronic medical instrument (chengdu) co., LTD
Product name: positron emission tomography and magnetic resonance imaging system
Applicant: Shanghai lianfilm medical technology co., LTD
Product name: the bioabsorber of the coronary artery rapamycin elutriate the stent system
Applicant: Beijing amet medical device co., LTD
Product name: bioabsorber of the coronary artery rapamycin elutriate the stent system
Applicant: shenzhen xinlitai bio-medical engineering co., LTD
Product name: near-infrared fluorescence imaging system
Applicant: Beijing digital precision medical technology co., LTD
, according to the blue parker instruments since 2017, the administration of drug safety device has released four public trial center, agreed to as many as 37 innovative medical device products access to special examination and approval.
And in all of 2016, the fda has identified 45 products to enter the special approval channel for innovative medical devices.
Obviously, this year, review of medical equipment examination and approval reform efforts is greatly increased, the year into the special channel and the innovation of the approved listing YiXie product quantity, also should be going to the roof. |