MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

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

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

By

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.

Regulatory Roundup

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

In case you missed it

RSS From Medical Design & Outsourcing

  • Supply Chain EVP Greg Smith sees fewer suppliers in Medtronic’s future
    All eyes are on Medtronic’s global operations and supply chain leader as he works to modernize its operations and scrutinize suppliers. EVP of Global Operations and Supply Chain Greg Smith anticipates fewer suppliers in Medtronic’s future, he said in an interview this week. Smith spoke with DeviceTalks Editorial Director Tom Salemi in his first published… […]
  • CeQur is launching a discreet, convenient ‘wearable insulin pen’
    CeQur designed its Simplicity device to make insulin delivery as seamless as possible for people with diabetes. When it comes to managing diabetes, CeQur wants to make insulin therapy as convenient as possible. For those who prefer to manage their own insulin delivery, the Simplicity device might just do exactly that. Simplicity, a wearable, disposable… […]
  • Meddux opens new facility in Colorado
    Engineering, design, development and manufacturing company Meddux announced that it opened a new facility in Boulder, Colorado. The new, 22,000-square-foot facility doubles the overall square footage from its previous location in Colorado. According to a news release, it helps the company to quadruple its product development area and double its manufacturing footprint. Meddux’s new facility… […]
  • Reducing the Overall Cost of Validation
    By PTI Engineered Plastics Reliable medical devices and equipment are essential for researchers and doctors to accurately diagnose and treat a wide range of diseases. That is why there is such stringent oversight from the FDA to ensure these products meet the necessary requirements and specifications. To ensure compliance with regulators, manufacturers follow installation qualification… […]
  • BBS Automation has a deal to buy medtech supplier Kahle Automation
    BBS Automation said it plans to purchase high-speed automation supplier Kahle Automation to expand its medtech and life sciences business. Kahle will operate as Kahle – a BBS Company, according to a news release from Munich, Germany-based BBS and Lombardy, Italy-based Kahle. The deal is subject to regulatory approval. Terms were not disclosed. Kahle’s co-owners —… […]
  • How safe is health information after the overturning of Roe?
    The U.S. Department of Health and Human Services today issued guidance meant to better protect women’s health information as state abortion bans kick in after the U.S. Supreme Court’s overturning of Roe v. Wade. Despite the HHS actions, women may still wonder whether their health information is entirely safe going forward — a potential challenge… […]
  • Dexcom focuses on early diabetes diagnosis as COVID links emerge
    New evidence is showing that COVID-19 may increase a person’s risk of diabetes, but it could be years until we know for sure. In the meantime, Dexcom (Nasdaq:DXCM) is getting ready, VP of Global Clinical Initiatives Tomas Walker said. Walker recently spoke with Medical Design & Outsourcing to discuss the San Diego-based diabetes device developer’s… […]
  • Blackrock Neurotech and Pitt work on first at-home BCI system for remote trials
    Blackrock Neurotech and the University of Pittsburgh’s Rehab Neural Engineering Labs (Pitt RNEL) are working together on the first portable brain-computer interface (BCI) to allow patients to participate in research trials from home. A Blackrock representative said it’s the final step as the company prepares to launch its first commercial product early next year. Salt… […]
  • How medical device companies are responding to abortion bans
    Days after the U.S. Supreme Court’s decision to overturn Roe v. Wade’s protection of abortion rights, medical device companies are among those reassuring workers about healthcare access. Corporate communications to employees and the public at large come as trigger laws in nearly half of the states outlaw abortion immediately. Some medtech companies are not using… […]
  • Philips updates on testing results for recalled ventilators
    Royal Philips (NYSE:PHG) says only a small portion of returned respiratory devices displayed the sound abatement foam degradation that sparked a massive recall. Repeated ozone cleaning may have made the problem worse. Those were some of the major takeaways from an update Philips provided today on a comprehensive test and research program it implemented after its… […]
  • ResMed names Lucile Blaise as new Sleep & Respiratory Care leader
    Lucile Blaise will be the new president of ResMed’s Sleep & Respiratory Care business starting July 1, ResMed (NYSE: RMD) said today. She replaces Jim Hollingshead, who became president and CEO of Insulet (Nasdaq:PODD) on June 1. ResMed President and COO Rob Douglas is serving as interim president of the Sleep & Respiratory Care during… […]

Leave a Reply