MassDevice

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

Home » Diabetes: DexCom wins FDA nod for Smart remote glucose monitor

Diabetes: DexCom wins FDA nod for Smart remote glucose monitor

By

Diabetes: DexCom wins FDA nod for Smart remote glucose monitor

(NSDQ:DXCM) said it won pre-market approval from the FDA for a new device designed to connect up to 5 smartphones with its G4 Platinum continuous glucose monitor.

The DexCom Smart device uses a secure wireless connection to transmit a patient’s blood glucose data from the G4 Platinum to 5 designated recipients, according to a press release.

The recipients can remotely monitor blood glucose levels and receive alerts via the Smart system "from almost anywhere" using an Apple (NSDQ:AAPL) iPhone or iPod Touch, DexCom said.

"Dexcom Share represents a significant advance in diabetes care by allowing people with diabetes to share important glucose information with their loved ones from afar," CEO Terrance Gregg said in prepared remarks. "With Dexcom Share, users, parents and personal caregivers now have a new tool to dramatically improve how they communicate about their diabetes."

The Share device works via a dock that receives the G4 Platinum. The dock, which also recharges the CGM’s battery, sends glucose data to the Share app on the patient’s Apple device via Bluetooth. The dock also uploads the data to a secure server, from which the designated recipients can receive notifications and trends data, according to the release.

"Continuous glucose monitoring offers a unique opportunity for patients with diabetes to aim for glucose levels close to the reference range found in persons without diabetes," Dr. Lori Laffel of Boston’s Joslin Diabetes Center said in a statement. "The ability to share the continuous glucose data remotely, to almost any location, is a remarkable advance. This new device should help patients, families and care providers succeed with their overall efforts to improve diabetes control and prevent both short-term and long-term complications while preserving quality of life for patients with diabetes and their family members."

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… […]