Fda Issues New Alert On Medtronic Insulin Pump Security
FDA issues new alert on Medtronic insulin pump security The agency warns that older MiniMed devices which have been recalled by Medtronic could be hacked and remotely controlled, adding to the list of cyber concerns for IoT devices. Dr. Suzanne Schwartz, FDA's deputy director of the Office of Strategic Partnerships and Technology Innovation, says all device manufacturers should "monitor and assess cybersecurity vulnerability risk, and to be proactive about disclosing vulnerabilities." The list of connected devices susceptible to attacks has now expanded once again, as the U.S. Food and Drug Administration issued an alert on June 27 warning that some insulin pumps from Medtronic are vulnerable to hackers, who could remotely gain access to and control them. In the alert , FDA notes that Medtronics MiniMed 508 and MiniMed Paradigm series insulin pumps, which have been recalled by the companies, are susceptible to remote access. The company "has identified 4,000 patients who are potentially using insulin pumps that are vulnerable to this issue," according to the FDA, and is "working with distributor partners to identify additional patients potentially using these pumps." The risks have to do with wireless communication between the MiniMed pumps and other devices such as blood glucose meters, continuous glucose monitoring systems and other medical devices, according to the agency. "The FDA is concerned that, due to cybersecurity vulnerabilities identified in the device, someone other than a patient, caregiver or health care provider could potentially connect wirelessly to a nearby MiniMed insulin pump and change the pumps settings," according to the alert. "This could allow a person to over deliver insulin to a patient, leading to low blood sugar (hypoglycemia), or to stop Continue reading >>
Fda Approves Medtronic’s New Automated Insulin Pump
The Food and Drug Administration approved for sale a significant advance toward a so-called artificial pancreas for Type 1 diabetes patients, a long-awaited insulin pump that aims to take some of the guesswork out of blood-sugar control. The product from Medtronic MDT -0.73% PLC, called the MiniMed 670G, combines two devices that attach to the outside of the body—a pump that delivers insulin through a tiny tube inserted under the skin, and a sensor that monitors blood glucose levels. The monitor tells the pump when to increase or decrease insulin flow to keep a person’s blood sugar in a healthy range. The device isn’t fully automated—users must enter their planned carbohydrate intake at each mealtime, and adjust the sensor twice a day by carrying out finger-prick tests to measure blood sugar. But doctors and patients called the MiniMed an important breakthrough likely to improve glucose control, reduce complications and lessen the constant worry of controlling Type 1 diabetes. Existing diabetes pumps and monitors can automatically shut off insulin flow when a person’s blood sugar levels veer toward being too low. But they can’t automatically deliver insulin when a person has high blood sugar, doctors said. “We’ve been looking forward to a day like this for a long time,” Derek Rapp, chief executive of the Juvenile Diabetes Research Foundation, or JDRF, said in an interview. “Ultimately it means less concern, less burden, more freedom and less fear.” Lori Laffel, a pediatric endocrinologist at the Joslin Diabetes Center at Harvard University, said the approval was a big step forward. Even so, she said patients still need to be able to take care of their diabetes and know how to operate the pump and sensor. “It doesn’t make diabetes simply go away Continue reading >>
The Minimed® 630g System
* CGM uses a special sensor to measure sugar levels just below the skin known as interstitial fluid. These sensor glucose (SG) values are different from blood glucose (BG) measurements using a BG meter. Sensor glucose values should not be used to make treatment decisions. Patients should always do a BG fingerstick before they make treatment decisions. ** The Bolus Wizard calculator does not account for manual injections and could prompt you to deliver more insulin than needed. Too much insulin may cause hypoglycemia. Consult with your healthcare professional for how long you need to wait after a manual injection before you can rely on the active insulin calculation of your Bolus Wizard calculator. † When calibrating three to four times a day and predictive and low alerts are both turned on. There may be times falling within a range approved by the FDA when the system may falsely alert (i.e., alerts when blood glucose levels are above the alert setting). ‡ Enlite Sensor Performance Clinical Appendix. § The pump is protected against the effects of continuous immersion in up to 12 feet (3.6 meters) of water for up to 24 hours at a time at the time of manufacture. This is classified as IPX8 rating. See user guide for more details. ¶ Assumes four injections per day for 30 days and one infusion set change every three days. 1. Battelino T, Conget I, Olsen B, et al. The use and efficacy of continuous glucose monitoring in type 1 diabetes treated with insulin pump therapy: a randomized controlled trial. Diabetologia. 2012;55:3155–3162. 2. Doyle EA, Weinzimer SA, Steffen AT, Ahern JAH, Vincent M, Tamborlane WV. A randomized prospective trial comparing the efficacy of insulin pump therapy with multiple daily injections using insulin glargine. Diabetes Care. 2004;27(7):1554 Continue reading >>
Medtronic Recalls Some Insulin Pumps As Fda Warns They Can Be Hacked
Medtronic recalls some insulin pumps as FDA warns they can be hacked "MiniMed 508" Medtronic insulin pumps have cybersecurity problems that can't be updated or patched, and the company is recalling them as a result, the Food and Drug Administration said Thursday. It's a rare example of a medical device recall over a cybersecurity issue, although security professionals and the FDA have raised numerous concerns over the vulnerability of these devices for years. The insulin pumps subject to the recall connect wirelessly to other insulin equpiment, including glucose meters, a monitoring system and controls that pump insulin. Omar Ishrak, chief executive officer of Medtronic Inc., speaks during an event at the 2016 Consumer Electronics Show (CES) in Las Vegas, Nevada, on Wednesday, Jan. 6, 2016. David Paul Morris | Bloomberg | Getty Images Medtronic is recalling some models of insulin pumps that are open to hacks, and the Food and Drug Administration warned consumers on Thursday that they cannot be patched to fix the holes. It's a rare example of a medical device recall over a cybersecurity issue, although security professionals and the FDA have raised numerous concerns over the vulnerability of these devices for years. The insulin pumps subject to the recall connect wirelessly to other insulin equipment, including glucose meters, a monitoring system and controls that pump insulin. "The FDA is concerned that, due to cybersecurity vulnerabilities identified in the device, someone other than a patient, caregiver or health care provider could potentially connect wirelessly to a nearby MiniMed insulin pump and change the pump's settings. This could allow a person to over deliver insulin to a patient, leading to low blood sugar ... or to stop insulin delivery, leading to high bl Continue reading >>
Medtronic Minimed 670g Trial Results: 44% Reduction In Hypoglycemia, 0.5% A1c Improvement
Highlights from the first study of a commercial automated insulin delivery device. Plus, Medtronic’s latest software updates! At the recent ADA Scientific Sessions, Medtronic presented data from its pivotal trial of the MiniMed 670G/Enlite 3 hybrid closed loop system, designed to provide evidence for regulatory approval. Compared to a two-week, “open-loop” phase (pump + CGM without automation), adolescents and adults spending three months on the hybrid closed loop system saw: A 0.5% reduction in A1c, bringing patients from a low initial A1c of 7.4% to 6.9%; A 44% reduction in time spent with low blood glucose (under 70 mg/dl); A 40% decline in time spent in dangerous hypoglycemia (under 50 mg/dl); An 11% decline in time spent over 180 mg/dl and an 8% improvement in time-in-range (71-180 mg/dl). This dual reduction in A1c and hypoglycemia demonstrates the power of automating insulin delivery – shaving off lows AND highs, particularly overnight. Take note of the images below, which show the combined daily glucose profiles in adults (B) and adolescents (C) for the open loop run-in (gray) and hybrid closed-loop with the MiniMed 670G (pink). The 670G tightened the range of glucose values throughout the entire day (particularly in adolescents) and was very effective overnight in both populations. Medtronic has submitted this system to the FDA as planned, with a US launch previously expected by April 2017. As we previously reported, of the 124 patients in the trial, a striking 80% have opted to continue using the device through the FDA’s continued access program – this demonstrates encouraging participant enthusiasm for the system, plus FDA comfort with real-world use of the device. Additionally, the Enlite 3 sensor looks much better than Medtronic’s current sens Continue reading >>
Whats Next For Medtronic Diabetes? A Look Into Cgm And Pump Pipeline
Whats next for Medtronic Diabetes? A Look into CGM and Pump Pipeline Medtronic hopes to launch at least 10 products over the next two years: new CGM and apps, 670G pump with Bluetooth, AI, and more! Medtronic held an investor meeting earlier this week, which included a presentation on the companys diabetes device pipeline including CGM, apps, and its next-gen closed plans. See the highlights below, broken down into major product launches planned within the next year (by April 2019), within two years (by April 2020), and beyond. (More specific timing than that was not given.) The pipeline is exciting, and reflects Medtronics bigger move to go beyond an insulin pump company especially by providing helpful tools to those on multiple daily injections (MDI). For a refresher on the diabetes technologydiscussed in this article CGM, insulin pumps, and more click here . Launch within the next year (by April 2019): Guardian Connect mobile CGM and Sugar.IQ app launch in the US. The standalone CGM will begin launching in the US between now and July on Apple iOS devices. (Android is in development.) It will require two fingersticks calibrations per day, is approved for seven-day wear, and is not approved for insulin dosing. Along with Guardian Connect, Medtronic will finally launch the long-awaited artificial-intelligence-powered Sugar.IQ companion app. As weve covered before , Sugar.IQ will function as a personal diabetes assistant, recognizing patterns in diabetes data. In a preliminary study, Sugar.IQ increased the time-in-range of CGM users by 33 minutes per day. Inner Circle CGM gamification. This new app was announced for the first time in Medtronics presentation. Medtronic CGM users will earn points for spending more time-in-range (70-180 mg/dl is how the system defines time Continue reading >>
Insulin Pump Hacker Says Vendor Medtronic Is Ignoring Security Risk
Jerome Radcliffe scared a lot of people — including himself, since he is a diabetic — when he showed how easy it was to hack an insulin pump from a distance at the Black Hat security conference in Las Vegas early this month. At the time, Radcliffe didn’t disclose the names of vendor names or models. He withheld the information to stay within legal boundaries, to protect himself, and to make sure he did not arm criminal hackers with the means to undertake the actual hacks. Today he revealed in a conference call that the company in question was Medtronic and it has not acknowledged that there is a security risk. “I chose not to disclose the details to protect the public safety of diabetics,” he said today in a conference call. But that was before he ran into a brick wall with Medtronic. Now he has worked with the Department of Homeland Security and the Computer Emergency Response Team to contact the vendor of insulin pumps. He said he expected to get honest, public disclosure from the vendor about what it would do to fix the problem. “I expect a company to be truthful with any press statements and to do fact checking,” he said. “I expect a comprehensive solution in a timely manner.” Today, Radcliffe revealed that the company was Medtronic, which had an engineer available at his talk in early August. Radcliffe said that on Aug. 9, Medtronic posted a statement on its web site that says it wasn’t really a security problem. Radcliffe was unsettled by that and emailed the engineer again. On Aug. 12, the DHS contacted the company and got no response. On Aug. 15, Congress sent a letter to the General Accounting Office asking for an investigation. And on Aug. 24 Medtronic gave an Associated Press reporter the same reinforced PR statement. CERT also contacted M Continue reading >>
Medtronic Deal With Aetna Ties Insulin Pump Payment To Patient Results
Medtronic deal with Aetna ties insulin pump payment to patient results (Reuters) - Medtronic Plc said on Monday it signed an agreement with health insurer Aetna Inc under which payment for its insulin pump systems will be tied to how well diabetes patients fare after switching from multiple daily insulin injections. The deal is the latest example of the move toward contracts for prescription drugs and medical devices that attempt to bring down soaring healthcare costs by tying reimbursements to whether the products achieve their intended results. The deal with Aetna will measure health outcomes for patients who transition to one of three Medtronic pumps that self-adjust to keep blood sugar levels in proper range based on patients individual needs for insulin. This agreement reinforces our shift towards value-based healthcare, Hooman Hakami, president of the Medtronic diabetes group, said in a statement. We know technology alone isnt enough and ultimately improved outcomes are what matter. Patients with type 1 diabetes and those with type 2 who have progressed to the need for insulin typically check blood sugar levels several times a day and inject insulin as needed. The pumps eliminate that chore. Medtronic declined to discuss financial details of the Aetna agreement, but said such deals tie revenue to achievement of clinical improvement targets, as well as shared savings for delivering on or exceeding clinical outcomes and cost targets. Suzanne Winter, vice president of the Medtronic diabetes group in the Americas, said the Aetna agreement will initially focus on whether patients on its pumps achieve their A1c targets, a commonly used measure of blood sugar levels. The American Diabetes Association recommends A1c levels below 7. In the future it may look at other meas Continue reading >>
Medtronic Recalls Minimed Insulin Pumps As Fda Warns About Hacking Risk
Medtronic recalls MiniMed insulin pumps as FDA warns about hacking risk Updated 2107 GMT (0507 HKT) June 27, 2019 Chat with us in Facebook Messenger. Find out what's happening in the world as it unfolds. The US Food and Drug Administration issued a warning on Thursday about possible risk of hacking for some diabetes patients' insulin pumps. Certain insulin pumps from Medtronic MiniMed have been recalled due to potential cybersecurity risks and it's recommended for people who use those insulin pumps to switch to different models, according to the FDA. Glucose monitor and app lets diabetics share diet data 02:33 In its warning, the FDA noted that these devices pose the risk of someone nearby connecting wirelessly and then potentially hacking into the devices. Insulin pumps are small computerized devices that can deliver insulin therapy to diabetes patients in continuous doses or as a surge around mealtime to help them control blood glucose levels. According to the FDA, the hacker could possibly change the pump's settings to either over-deliver insulin to a patient, which could lead to low blood sugar, or to stop insulin delivery altogether, which could lead to high blood sugar and a life-threatening complication called diabetic ketoacidosis . In the United States, Medtronic has identified about 4,000 patients who are potentially using insulin pumps that are vulnerable to this issue and the company is working with distributor partners to identify additional patients potentially using these pumps, according to the FDA. Diabetes patients suffer as drug prices soar 02:15 "The FDA urges manufacturers everywhere to remain vigilant about their medical products -- to monitor and assess cybersecurity vulnerability risk, and to be proactive about disclosing vulnerabilities and mit Continue reading >>
Medtronic Rushes To Replace Insulin Pumps After Flaws Found
Note. Naked Security cannot provide medical advice nor answer questions about specific Medtronic devices. If youre concerned please contact your health professional or Medtronic directly on (US) 855-275-2717. US medical equipment giant Medtronic has announced the immediate recall of all MiniMed 508 and Paradigm series insulin pumps after researchers uncovered serious security flaws which cant be patched. The news emerged last week when the company started sending recall letters to all US users of the device, a warning echoed by a public alert issued by the US Food and Drug Administration (FDA). According to the FDA, Medtronic has identified around 4,000 US patients using affected models although an unknown number of others (including patients in other countries) will have received them through third parties. This is still a relatively small number, which is perhaps explained by the fact that both pumps are older models dating back to 2012 that were withdrawn from sale in October 2018. The job of a pump is to deliver insulin to a patient throughout the day via a catheter implanted under the skin, which removes the need for regular injections to maintain stable blood glucose levels. However, to do this, the pumps need to connect to a separate continuous glucose monitor (CGM) sensor which for a decade or so has been implemented wirelessly using Bluetooth. The final element of the system is the CareLink USB, which plugs into a computer and gives patients a way to send the pump dosing commands wirelessly while sharing data with health providers. Neither Medtronic nor the FDA has revealed much about the flaws nor who discovered them but the alert states that the weaknesses lie in the way the wireless part of the system was implemented. Thats significant because in March 2019 Continue reading >>
Fda Warning: Medtronic Minimed Insulin Pumps Could Be Hijacked By Hackers
The Food and Drug Administration has issued an urgent warning to users of certain Medtronic MiniMed insulin pumps to cease using them immediately due to fears they are vulnerable to cyberattacks. The FDA fears that a hacker could wirelessly connect to the devices and alter the dose of insulin given to usersa potentially fatal attack. The risk comes from a vulnerability in the wireless connection between select Medtronic devices and the remote controller and CareLink USB device that allows users to interact with the Medtronic pumps. As the FDA explains: The FDA is concerned that, due to cybersecurity vulnerabilities identified in the device, someone other than a patient, caregiver or health care provider could potentially connect wirelessly to a nearby MiniMed insulin pump and change the pumps settings. This could allow a person to over deliver insulin to a patient, leading to low blood sugar (hypoglycemia), or to stop insulin delivery, leading to high blood sugar and diabetic ketoacidosis (a buildup of acids in the blood). Here are the models of Medtronic MiniMed that are susceptible to the attack: MiniMed Paradigm 511 (all versions of the device) MiniMed Paradigm 512/712 (all versions of the device) MiniMed Paradigm 515/715 (all versions of the device) MiniMed Paradigm 522/722 (all versions of the device) MiniMed Paradigm 522K/722K (all versions of the device) MiniMed Paradigm 523/723 (version 2.4A or lower) MiniMed Paradigm 523K/723K (version 2.4A or lower) MiniMed Paradigm 712E* (all versions of the device) MiniMed Paradigm Veo 554CM/754CM* (version 2.7A or lower) MiniMed Paradigm Veo 554/754* (version 2.6A or lower) The FDA notes that as of now, no attackers are known to have taken advantage of the flaw in the Medtronic devices. However, the agency is warning all u Continue reading >>
Tandem Says Data Shows Its Touchscreen Insulin Pump Outperforms Medtronic's
In a head-to-head comparison of sensor-augmented insulin pumps, the touchscreen device from Tandem Diabetes Care outperformed that from Medtronic, according to new data presented at the Annual Advanced Technologies and Treatments for Diabetes conference in Paris. The self-reported data from San Diego-based Tandem comes from a retrospective study analyzing de-identified data from 3,046 Tandem SAP users data, which was collected via the t:connect Diabetes Management App between October 2015 and August 2016. Comparing the Tandem data to Medtronic's CareLink Therapy Management data sets under the same set of criteria – people with type 1 and type 2 diabetes using a SAP for at least six months, and more than 15 days of CGM use during the first six months – the Tandem SAP system demonstrated clinical advantages over the Medtronic MiniMed SAP including reduced hypoglycemia, increased time in range and overall glycemic control. Both companies’ continuous glucose monitors receive data from a wearable sensor, but the Tandem maintains that the t:slim Insulin Pump 2’s touchscreen makes for easier use. “This study suggests that our simple-to-use touchscreen interface may translate to improved clinical outcomes for people with diabetes,” Tandem’s Director of Clinical Affairs Betsy Dokken said in a statement. “The data reinforces our assertion that not every insulin pump delivers the same benefits, and that choice in therapy options is important for the diabetes community.” Tandem also presented data from a study showing Tandem pump use associated with a reduced risk of hypoglycemia compared to previous methods of diabetes therapy. A group of 1,370 Tandem users (90 percent were type 1 and 10 percent were type 2) who had been using the pump for at least a year filled Continue reading >>
Medtronic Begins To Roll Out State-of-the-art Insulin Pump
Two Minnesota teens with type 1 diabetes are some of the first patients in the nation to start using Medtronic's new insulin pump, a first-of-its-kind machine that can predict when a person will have a diabetic emergency and automatically adjust insulin levels to prevent it. Allison Scholl, 16, of Edina, and Eleanor Hedlund, 17, of Minneapolis, recently received their new Medtronic MiniMed 670G insulin pumps after using a similar but less-advanced Medtronic pump known as the 630G. Their new 670G units were officially activated on Wednesday in a manual mode, but both teens said they were eager to switch the devices into "auto mode" next week. "I'm a pretty avid endurance athlete. And it's obviously pretty hard to try and control blood sugar when you are constantly working out or being active," Hedlund said Wednesday after receiving training on how to use the device at Park Nicollet's International Diabetes Center in St. Louis Park. "I'm hoping that it will make me able to train more, or not have to drop out of practice. ... Hard workouts are hard to do when your blood sugar is out of whack." Scholl, meanwhile, was a longtime user of a different company's insulin pump. She said she switched brands last fall after Medtronic announced a "Priority Access" program that allowed people who purchase a 630G system to be "first in line" when the newer 670G is available commercially, which happened this week. Medtronic is hoping other type 1 diabetics will follow Scholl's lead and get in line for the 670G. Company CEO Omar Ishrak said in an earnings call with investors in February that Medtronic diabetes-device sales may slow during the quarter ending in April, as patients postponed purchases in anticipation of the 670G. But Ishrak also reiterated that Medtronic's diabetes business Continue reading >>
Medtronic Warns Patients Of Minimed Insulin Pump Safety Issue
/ Medtronic warns patients of MiniMed insulin pump safety issue Medtronic warns patients of MiniMed insulin pump safety issue Medtronic (NYSE: MDT ) is warning patients who use its MiniMed 600 series insulin pumps of an issue that could cause a dangerous over- or under-dosing of insulin. In a letter to patients, the company said that the pumps insulin reservoir may become loose if a retainer ring breaks, preventing a proper lock. Dropping the pump or bumping it on a hard surface may break that ring, the company said. If the reservoir is not properly locked into the pump, it could lead to over- or under-delivery of insulin, which could then result in hypoglycemia or hyperglycemia. The recall coversMiniMed 630G (model MMT-1715) and MiniMed 670G (model MMT-1780). A company spokesperson told the StarTribune of Minneapolis that Medtronic had received one report of a patient being hospitalized due to a retainer-ring issue, and one report of a death which may have been associated with the issue. Medtronic advised patients to stop using the device if the reservoir does not lock into the pump or if the is loose, damaged or missing. The company also said patients who drop or bump their pumps should examine the retainer ring and check that the reservoir locks properly. All patients should routinely check the retainer ring and check that your reservoir locks in place at every set change, the company added. The company also said it had notified the FDA of the issue. Medtronic did not immediately respond to a request for comment on the recall. Medtronics MiniMed 670G system is designed to automatically track and adjust a patients blood sugar levels by measuring blood glucose every few minutes and automating the dosing of insulin. The automated insulin delivery system first won FDA a Continue reading >>
Why I Won't Be Switching To Medtronic's 670g Insulin Delivery System Billed As The First Artificial Pancreas - Medcity News
5 Comments / Feb 26, 2018 at 5:32 PM When Medtronic won approval for the MiniMed 670G from the FDA in 2016 , it was a big deal. Advertised as The Worlds First Hybrid Closed Loop System, it is the first commercial product of its kind able to automate insulin delivery and requiring lesser patient input than in the past. However, after reading more about the specifics, and having heard more first-hand accounts, I can now safely say that I am somewhat underwhelmed. When evaluating the 670G I was exclusively looking at the features of the auto mode in comparison to the system I use now. That is the OpenAPS, which is an open source artificial pancreas solution built using an Intel Edison (tiny computer) and a Medtronic insulin pump. My initial thought was that it might be nice to use a commercial solution instead of an open source one if it could make my daily life easier (there are elements of using an open source solution that are tiring at best). Here I lay out the reasons that drove my decision to stick with what I have instead of switching to Medtronics CGM. It should be noted, however, there is no one-size-fits-all solution for insulin-dependent diabetics. Ultimately, its a personal choice. What its really doing, not just what the basal rate has been adjusted to, but how the system got to that decision. Its not that I always read the exact calculations of the OpenAPS algorithm, but I could because I can access my live information at any time. I can access not just my blood glucose (BG) and basal insulin rate, but also the actual numbers and calculations going into the recommendations and changes that the system is making. No personalized targets for blood glucose levels The system targets 120 all of the time. The only other option is a temp target of 150 meant for exer Continue reading >>
