Dive Brief Medtronic has found a cybersecurity vulnerability in an optional messaging feature in its Paceart Optima cardiac device data workflow system and reported the problem to the U.S. Cybersecurity & Infrastructure Security Agency. Medtronic has not observed any unauthorized access or patient harm related to the issue, the device maker said in an emailed statement. The company said it has notified healthcare delivery organizations about the vulnerability and has provided them with instructions to eliminate it. Dive Insight The number of data breaches in healthcare continues to climb as the industry has become a prime target for cyber criminals who seek to access its troves of patient information. As more connected medical devices make their way into patient homes, ransomware, phishing and software vulnerabilities are among the biggest challenges facing the sector. Medtronic’s Paceart Optima software application, which runs on a hospital’s Windows server, collects cardiac device data from ...
Dive Brief The U.S. Food and Drug Administration is asking for public input on the transition to at-home care and how it can support enabling technologies. As part of its push to advance health equity, the FDA has posed a series of home-care questions to the medtech industry, including a query about how it can support the development of devices for use in non-clinical care settings. Other questions cover how digital health technologies can support home-based healthcare, the device design attributes that facilitate use outside of clinical settings and methods for generating data to inform regulatory reviews. Dive Insight The development of remote patient-monitoring devices and other connected medical technologies has made it possible to treat more patients at home. In theory, home care can help reduce costs and risks associated with spending time in healthcare facilities and lessen burdens on patients. The COVID-19 pandemic accelerated uptake and validation of ...
Dive Brief Almost all the claimants in a lawsuit against Sterigenics over damage allegedly caused by ethylene oxide (EtO) — used to sterilize reusable medical devices — have opted to participate in the settlement. Early this year, contract device sterilizer Sterigenics and its parent company Sotera Health agreed to pay $408 million to resolve hundreds of ethylene oxide cases without admitting liability. The latest update shows that all but three of the 882 claimants have accepted the settlement. The suits of the claimants who opted out will proceed to pretrial discovery and the “immaterial fraction” of the settlement they represent will revert to Sterigenics at the end of the year. Dive Insight The settlement relates to Sterigenics’ former facility in Willowbrook, Illinois. In September, a jury ruled in favor of cancer survivor Susan Kamuda and awarded her $358.7 million. Months later, the company agreed to settle with another 882 people ...
Dive Brief A lawyer has filed civil and criminal complaints against Philips in France over its recalled respiratory medical devices. The civil complaint covers 1,341 claimants who are seeking compensation for non-material damages tied to Philips’ failure to inform them of the danger the devices may present and for “anxiety-related harm.” A related criminal complaint was lodged by 215 people who accuse Philips of endangering the lives of others, aggravated deception and administration of harmful substances. Dive Insight France has emerged as a hotspot for action against Philips. Last year, the French device regulator ordered Philips to repair or replace all of its recalled respiratory devices by the end of 2022. When Philips missed the deadline, the agency applied more pressure to the company and referred the case to a prosecutor who could bring criminal proceedings. In parallel, lawyers behind a collective legal action platform have been preparing cases against ...
Dive Brief Boulder Sterilization is introducing contract chlorine dioxide sterilization services this summer to provide medical device manufacturers with an alternative to ethylene oxide (EtO). The rollout of the service will make Boulder Sterilization, a division of Boulder iQ, part of a small group of companies to offer medtech sterilization using the gas and, it claims, the only provider to offer both EtO and chlorine dioxide services. Boulder Sterilization’s addition of chlorine dioxide capabilities comes as the industry races to find alternatives to EtO ahead of restrictions on the use of the carcinogenic gas. Dive Insight Interest in using chlorine dioxide to sterilize medical devices dates back decades. A patent filed in 1982 described the use of chlorine dioxide to “sterilize surfaces, especially the gas impermeable surfaces of implements commonly employed in the medical sciences.” Yet, while some sterilization companies such as ClorDiSys Solutions have deployed the approach, EtO has ...
Dive Brief The U.S. Food and Drug Administration has issued a warning letter to iRhythm Technologies after inspectors found fault with practices at a facility that makes its heart monitors. According to iRhythm, the FDA has alleged “nonconformities to regulations for medical devices, including medical device reporting requirements, relating to the company’s Zio AT System and medical device quality system requirements.” iRhythm can continue to manufacture and sell its products and does not expect the warning letter to materially affect its financial results. However, the situation comes at a time when iRhythm is working to continue the recent recovery of sales of Zio AT. Dive Insight FDA inspectors concluded their assessment of iRhythm’s facility in Cypress, Calif. in August 2022. The FDA visit led to a Form 483 later that month. iRhythm took steps to address the concerns raised in the 483 but its actions failed to stop the FDA ...
By Rachel Cohrs CMS Administrator Chiquita Brooks-LasureCHIP SOMODEVILLA/GETTY IMAGES WASHINGTON — Despite pressure from Congress and advocates, Medicare isn’t changing its coverage plan for new Alzheimer’s drugs anytime soon. Medicare on Thursday issued a statement reiterating its intent to require patient registries to collect data about how medications perform even after they gain full Food and Drug Administration approval. Eisai’s Leqembi could gain full approval within the next month, so time is running short for the agency to solidify details. Right now, Leqembi and Biogen’s Aduhelm only have accelerated approval from the FDA, and are subject to even more restrictive coverage limits that require patients to be enrolled in a clinical trial to receive the medications. If Leqembi wins full approval, those restrictions will relax slightly, but providers would still need to collect data about all patients who receive the drugs in a patient registry. Medicare had previously announced ...
Dive Brief MedTech Europe has set out its vision for cybersecurity in the medical technology ecosystem in a paper that argues for industry-specific legislation. The trade group outlines three areas of discussion, starting with its belief that medtech security should be regulated under sectoral legislation such as the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR). Other parts of the paper address MedTech Europe’s preferred approach for tackling ransomware and support for actions to improve digital literacy in general and cybersecurity skills in particular. Dive Insight More connected medical devices have increased the risk that hackers will access confidential data or gain the ability to modify technologies in ways that put patients at risk. As the risks increase, medical device manufacturers “continue to invest significant resources in guaranteeing state of the art cybersecurity for all their products and services,” the trade group wrote. Other groups including ...
Drugdu.com expert’s response: 1.Pre-Submission Consultation: This initial step often involves a formal or informal consultation with the FDA to discuss the product’s classification, the type of application needed, and data requirements. 2.Preparing Documentation: Following consultation, you’ll need to prepare all necessary documentation, which usually includes preclinical and clinical data, product information, manufacturing details, labeling, and more. The exact documentation needed will depend on the product classification and type of application. 3.Submission of Application: The next step is to submit your application or registration to the FDA. The type of application may include a Premarket Notification (510(k)), Premarket Approval (PMA), Investigational Device Exemption (IDE), or others, based on the product classification. 4.FDA Review: Once the FDA receives your application, they will conduct a review. This involves an assessment of all submitted materials and may include inspections, additional data requests, and more. 5.FDA Decision: After the review process, ...
Dive Brief Boston Scientific has canceled a planned $230 million acquisition of a majority stake in M.I.Tech, a Korean manufacturer of non-vascular stents. The U.S. Federal Trade Commission (FTC) shared news of the cancelation, claiming that Boston Scientific took the action in response to investigations by its staff and overseas enforcement partners. Boston Scientific, which is reportedly considering a $10 billion takeover of cardiovascular device maker ShockWave, agreed to buy a 64% stake in M.I.Tech in June and originally expected to close the deal in the second half of 2022. Dive Insight M.I.Tech is a publicly traded Korean manufacturer of medical devices for endoscopic and urologic procedures, including a line of non-vascular, self-expanding metal stents that Boston Scientific has distributed in Japan since 2015. At the time of the agreement, Boston Scientific framed the products as complementary to its portfolio, and the deal as a way to help M.I.Tech expand ...
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