a*****m
发帖数: 1010 | 1 我在一家公司做这个
属于biosensor
似乎做这个的bme的人特别少
想认识同行，交流下 |
a*i
发帖数: 1652 | 2 几年前在迈阿密的一个展会上见到好多厂家，似乎竞争激烈 |
D******s
发帖数: 11 | 3 你好！我一直做糖尿病相关器械，血糖仪和动态血糖仪都做过。你想聊聊哪些方面的事
情啊？
【在 a*****m 的大作中提到】
: 我在一家公司做这个
: 属于biosensor
: 似乎做这个的bme的人特别少
: 想认识同行，交流下
|
l*****g
发帖数: 556 | 4 How difficult it will be to modify current OTC glucose meter to test in the
0 to 30 mg/dl range?
【在 D******s 的大作中提到】
: 你好！我一直做糖尿病相关器械，血糖仪和动态血糖仪都做过。你想聊聊哪些方面的事
: 情啊？
|
D******s
发帖数: 11 | 5 The question should be - Is that clinically meaningful to have meter measure
anywhere lower than 40mg/dl? Under 50 or 60 mg/dl would be hypo already. On
top of that, with two new FDA guidance coming out, any claim below 40 mg/dl
would be unrealistic to achieve the accuracy requirement. Technically it is
feasible, but from clinical and regulatory standpoint this is not something
manufacturers want to claim.
the
【在 l*****g 的大作中提到】
: How difficult it will be to modify current OTC glucose meter to test in the
: 0 to 30 mg/dl range?
|
a*****m
发帖数: 1010 | 6 如果你要测这个range的，最简单的方法是自己做个葡萄糖电极去测。。。
the
【在 l*****g 的大作中提到】
: How difficult it will be to modify current OTC glucose meter to test in the
: 0 to 30 mg/dl range?
|
l*****g
发帖数: 556 | 7
measure
On
dl
is
something
Totally agree. For blood, it is unnecessary.
Which company's meter and test stripe is already feasible at this range now?
For POC meters, many of them can do this range (passed 510k).
【在 D******s 的大作中提到】
: The question should be - Is that clinically meaningful to have meter measure
: anywhere lower than 40mg/dl? Under 50 or 60 mg/dl would be hypo already. On
: top of that, with two new FDA guidance coming out, any claim below 40 mg/dl
: would be unrealistic to achieve the accuracy requirement. Technically it is
: feasible, but from clinical and regulatory standpoint this is not something
: manufacturers want to claim.
:
: the
|
l*****g
发帖数: 556 | 8
That will take a long time to launch product.
【在 a*****m 的大作中提到】
: 如果你要测这个range的，最简单的方法是自己做个葡萄糖电极去测。。。
:
: the
|
