12
NEWS
FDA clears Omnipod GO
Insulet has announced the FDA clearance of Omnipod GO, an insulin delivery
device cleared for use for people with type 2 diabetes age 18 or older who would
typically take daily injections of long-acting insulin.
Omnipod GO is a standalone, wearable, insulin delivery system that provides
a fixed rate of continuous rapid-acting insulin for 72 hours. It features a tubeless
and waterproof Pod and seven different pre-programmed daily rates, ranging
from 10 to 40 units per day, and operates without the need for a handheld device
to control the Pod. It has been cleared for use with the following U-100 insulins:
NovoLog, Fiasp, Humalog, Admelog, and Lyumjev.
The product was developed to serve people with Type 2 diabetes earlier in
their treatment journey by starting them on Pod therapy for their insulin delivery,
rather than daily injections. If a patient becomes insulin-intensive, meaning they
require both basal and bolus insulin, the transition to another Omnipod product
would be seamless.
To read more, CLICK HERE.
AstraZeneca & Sernova
Sernova has entered into a preclinical research collaboration on drug delivery
with AstraZeneca, with the aim of evaluating the use of Sernova's Cell Pouch
System in combination with AstraZeneca's novel therapeutic cells.
Sernova's Cell Pouch System as an implantable and scalable medical device
that forms a natural environment in the body for the long-term survival and
function of therapeutic cells. Those cells release necessary proteins or factors
missing from the body to treat chronic diseases, including insulin-dependent
diabetes.
AstraZeneca aims to use the Sernova Cell Pouch System as a potential
platform for integration with its cell therapies. Under the terms of the agreement,
AstraZeneca will lead and completely fund development of the cell technologies
and pre-clinical activities in conjunction with Sernova. Any therapeutic
applications found could lead to subsequent product development activities
between the two companies.
FDA clears iLet ACE pump
The FDA has cleared the Beta Bionics iLet ACE Pump and the iLet Dosing Decision
Software for individuals 6 years of age and older with Type 1 diabetes.
When combined with a compatible FDA-cleared integrated continuous
glucose monitor (iCGM), the iLet ACE Pump and the iLet Dosing Decision
Software form a new automated insulin dosing (AID) system called the iLet Bionic
Pancreas.
The iLet Bionic Pancreas uses an adaptive closed-loop algorithm requiring
only a user's body weight for start-up and no additional insulin dosing
parameters. This adaptive algorithm is able to determine and command insulin
delivery removing the need to manually adjust insulin pump therapy settings and
variables. The device also includes a new meal announcement feature that allows
users to estimate the amount of carbs in their meal as small, medium, or large.
The adaptive algorithm will learn over time to respond to the users' individual
insulin needs.
To read more, CLICK HERE.
CE marks
until 2030
proposed
Because Great Britain never
adopted the European Union's
Medical Devices Regulation
(MDR) because its delayed
date of application happened
after the end of the Brexit
transition period, it needs
its own regulatory regime
for medical devices and in
vitro diagnostics (IVDs). The
government outlined its plans
last year and extended the
transitional arrangements
out to July 2024. Under new
plans, 'core aspects' of the
future regime for medical
devices will apply from 1 July
2025, although manufacturers
will still be able to sell CEmarked
devices in the UK for
years after that date.
Under legislation that
the government plans to
introduce soon, CE-marked
'general medical devices' that
comply with the outgoing EU
directives can be sold in the
UK until 30 June 2028. The
transition period for IVDs
placed on the market under
the outgoing directive, and
for all medical devices that
comply with MDR, will end on
30 June 2030. The transition
period applies to CE marks
granted before the UK fully
establishes its own medtech
regulatory regime in July
2025.
Manufacturers with CE
marks that expire after that
date will need to get certified
under the new system.
To read more,
CLICK HERE.