The U.S. Homeland Security Dept. yesterday warned of two more cybersecurity vulnerabilities with the Alaris infusion pump made by Becton, Dickinson (NYSE:BDX). The DHS Industrial Control Systems Cyber Emergency Response Team, acting on weaknesses unearthed by researchers at CyberMDX, said the vulnerabilities could allow a malicious attacker to completely disable BD’s Alaris Gateway Workstation and install malware […]
Biocorp wins CE Mark for Mallya insulin pen sensor
Biocorp said this week that it received CE Mark approval for its Mallya device. The Mallya device is a smart sensor that turns insulin pens into connected devices. It records treatment information and sends the data to a smartphone application that allows for an automatic recording of doses to manage diabetes treatment. The France-based company […]
Ivenix wins 510(k) clearance for infusion system
Ivenix said today that its infusion system won 510(k) clearance from the FDA. The large-volume pump and infusion system features a “smartphone-like” user interface and a suite of administration tools to remotely monitor infusions, according to Ivenix. The Boston-based company reported that infusion-related adverse drug events make up more than $2 million in healthcare costs […]
Diabetes patients could soon replace fingersticks with Senseonics implantable CGM
Senseonics (NYSE:SENS) recently announced that the U.S. FDA has approved using the Eversense implantable continuous glucose monitoring (CGM) system as a replacement for fingersticks. Officials at the Germantown, Md.–based medical device company described the FDA approval for the non-adjunctive indication (dosing claim) as a major milestone. The company will make a new app available in coming months […]
Human factors and usability investment considerations for medtech companies
By Mark Tavano, Emergo Group Embedding human factors engineering (HFE) and usability studies early in medical device design and development cycles can yield benefits beyond regulatory compliance for manufacturers. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect […]
Chinese authorities update regulatory guidelines
By Stewart Eisenhart, Emergo Group China’s National Medical Product Administration (NMPA) has clarified various technical review and information guidelines related to medical device registration and approval. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of DrugDeliveryBusiness.com […]
U.K. says doctors should limit use of paclitaxel devices
U.K. medtech regulators have recommended a ban on routine use of paclitaxel drug-coated balloons (DCBs) and drug-eluting stents in patients with intermittent leg cramps, but held back on recommending the same for patients with critical limb ischemia. U.S., U.K. and French regulators began raising concerns about the risk of increased long-term mortality in people with […]
Nemaura Medical wins CE Mark for SugarBeat CGM
Nemaura Medical (NSDQ:NMRD) said yesterday that it won CE Mark approval for its SugarBEAT continuous glucose monitor. The SugarBEAT CGM is a flexible, disposable patch that’s connected to a rechargeable transmitter and Bluetooth-enabled smartphone app, designed to deliver glucose readings at five-minute intervals throughout the day. The company says the device allows users to spend more […]
India regulators list risk classifications for 12 notified medical devices
By Stewart Eisenhart, Emergo Group The Indian Central Drugs Standard Control Organization (CDSCO) has set risk classifications for 12 products scheduled for notification and regulation as medical devices starting April 1, 2020. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do […]
FDA readies for SaMD Pre-Cert program test cases
By Stewart Eisenhart, Emergo Group The US Food and Drug Administration has called for test cases from developers for its nascent Pre-Cert certification program for software as a medical device (SaMD). Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not […]
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