Diabetes: Roche lands FDA nod for Accu-Chek Nano | Regulatory Roundup

January 12, 2012 By MassDevice staff

Roche (PINK:RHHBY) won clearance from the U.S. Food & Drug Administration for its Accu-Chek Nano SmartView blood glucose monitoring system.

The Switzerland-based biotech builder’s no code meter is smaller than a credit card that allows patients to customize test reminders, pre and post meal markers and calculate their average glucose levels.

"It is easy-to-use and will help people with diabetes regularly check their blood glucose levels before making informed therapy and lifestyle adjustments," Marc Gibeley, head of Roche Diabetes Care North America said in prepared remarks. "We look forward to its launch later this year."

Sign up to get our free newsletters delivered right to your inbox

The company plans to launch the Accu-Chek Nano to U.S. customers during the first half of 2012.

The new system is part of the same product line as the Accu-Chek Aviva and Accu-Chek Performa systems that have already been launched in Europe Union, Latin-America, Asia and the Pacific.

Roche recalled a member of the Accu-Chek family in early 2011 when it discovered that its Accu-Chek FlexLink Plus could under-deliver insulin when the tube that delivers the medicine becomes kinked.

Masimo lands FDA clearance for Pronto-7 system
Irvine, Calif.-based Masimo (NSDQ:MASI) landed 510(k) clearance by the FDA for its Masimo Pronto-7, a handheld device for noninvasive spot-checking of hemoglobin, spO2, pulse rate and perfusion index. Read more

Biomet wins FDA nod for 2 devices
Orthopedic and biotech device maker Biomet Inc. won clearance by the FDA for its Comprehensive segmental revision system and its E1 humeral bearing for use with its Comprehensive reverse shoulder system. The SRS system is specifically designed to address bone deficiency after cancer treatments. Read more

FDA grants 510(k) clearance to Varian planning system
The federal watchdog agency granted 510(k) clearance to Palo Alto, Calif.-based Varian Medical Systems for a new radiotherapy treatment planning tool designed to work with its Eclipse treatment planning software. Read more

Ortho Kinematics’s KineGraph VMA system lands FDA clearance
Austin, Texas-based Ortho Kinematics landed FDA approval for its KineGraph vertebral motion analyzer system. The KineGraph VMA is designed to improve the flexion/extension x-ray, a test routinely prescribed by spine doctors. Read more

Dehaier Medical wins CE Mark
Dehaier Medical Systems landed CE Mark approval to sell its sleep diagnostic devices and air compressors in Europe. The compressors are already available in Republic, Hungary, Kyrgyzstan, Pakistan, Ukraine, and the Philippines. Read more

How COVID-19 impacts FDA interactions with medical device manufacturers
By Stewart Eisenhart, Emergo Group The US Food and Drug Administration may revise performance goals and timelines set under the Medical Device User Fee Amendments IV (MDUFA IV) as emergency efforts targeting the coronavirus pandemic take up more of the agency’s time. Get the full story here at the Emergo Group’s blog. The opinions expressed… […]
Switchback Medical adds ‘sandbox approach’ to device testing
Contract manufacturer Switchback Medical (Maple Grove, Minn.) today announced that it has added a new division. Switchback BioSim Innovations offers functional dynamic biosimulator model development, cell culture services and physician training, according to the company. Biosimulator models use animal and human tissue to create functional models, such as a pumping heart with working valves to… […]
Smith College team wins ventilator design challenge
A team of Smith College engineering alumnae, staff and faculty has won the CoVent-19 Challenge to design a rapidly deployable ventilator to address shortages caused by the COVID-19 pandemic, particularly in developing countries. A dozen anesthesiology resident physicians from Massachusetts General Hospital kicked off the public challenge April 1, attracting 200 entries. The 30-person team… […]
FDA gives certain device makers more time to add UDIs
The FDA said today that it will grant manufacturers of Class 1 and unclassified medical devices and certain others more time to add unique device identifiers (UDIs) to their products. These companies will now have until Sept. 24, 2022 to comply with the agency’s UDI rule, including standard date formatting, labeling and Global Unique Device… […]
Eurofins launches 10-minute COVID-19 exposure testing device
Eurofins (Paris:ERF.PA) announced today that it launched its rapid point-of-care testing devices to identify past exposure to COVID-19. The serology-based, finger-prick tests detect antibodies with a sensitivity of 94.5% from 19 days following the onset of symptoms, with results coming in just 10 minutes, according to a news release. Get the full story at our sister site,… […]
How is RF technology shaping the future of medtech?
RF technology, including microwaves, isn’t just about wireless communications or military radar these days. Times Microwave Systems experts point out that it is increasingly important when it comes to medtech. Many medical electronics systems such as magnetic resonance imaging (MRI) systems for cancer detection rely on RF/microwave technology. Times Microwave Systems (Wallingford, Conn.) is hosting… […]
Medical device litigation and COVID-19: What you need to know
The COVID-19 pandemic is creating a new set of medical device litigation challenges — but also a chance for an industry reset. One of Greenberg Traurig’s top medtech litigation lawyers shares her insights. Sara Thompson doesn’t take any guff when she tells people that she defends medical device and pharmaceutical companies from lawsuits. “I say,… […]
Mayo Clinic needed to engineer its way through COVID-19: Here’s what they did.
The health system’s medical and engineering staffs had to devise their own solutions for lab gear, PPE and operating room air decontamination. As COVID-19 settles into several regions of the U.S., healthcare systems that once sat on the sidelines likely will find themselves in the same situation as their counterparts in the Northeast did earlier… […]
Xenco Medical launches porous spinal implant
Xenco Medical this week said it launched its Cancellex porous titanium lumbar interbodies. The injection-molded titanium foam spinal implants are designed to be pre-attached to disposable, composite polymer instruments. They feature interconnected porosity throughout each implant and are designed to promote bone apposition and facilitate vascularization Each implant is sterile packaged and comes pre-attached to… […]
Applied Plastics adds VP of sales
Applied Plastics (Norwood, Mass.) — maker of PTFE-coated products for advanced catheter systems — announced today that Michael Brown has joined the company as VP of sales and marketing. Brown will be responsible for global sales and marketing, including Applied Plastics’ new online store, which offers shipment within the U.S. and Europe. The company recently… […]
Heraeus Medical Components opens new Collaboration Hub outside Minneapolis
Heraeus Medical Components recently announced that it has opened a new nearly 67,000-square-foot Collaboration Hub in the Minneapolis-St. Paul medtech cluster. The Collaboration Hub — a completely new location near the Heraeus’ existing Fridley, Minn. facility — is meant to provide the company’s customers with the opportunity to work on-site with Heraeus Medical component R&D… […]