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. Get the full story at our sister site, Drug Delivery Business News.
Could this agreement boost continuous glucose monitor use?
An international panel of patients, physicians and researchers has agreed upon evidence-based target glycemic ranges for people who use continuous glucose monitors (CGMs) to control their diabetes. Announced today at the American Diabetes Association (ADA) conference in San Francisco, the International Consensus on Time-in-Range (TIR) was based on data from large pre-CGM clinical trials, CGM […]
Beta Bionics starts new trial for bionic pancreas
Boston-based Beta Bionics said this week that the first patients have begun home use of dasiglucagon in a clinical trial of the company’s iLet bionic pancreas system for people with Type 1 diabetes. The iLet device features an autonomous, dual-chamber infusion pump that is powered by dosing algorithms. Using machine learning and data from a continuous glucose […]
Smiths Medical, United Therapeutics conspired to stifle generic Remodulin, Sandoz alleges
Smiths Medical allegedly conspired with United Therapeutics to stifle a generic version of pulmonary arterial hypertension drug Remodulin, according to a lawsuit filed this week by Novartis (NYSE:NVS) unit Sandoz. The Smiths Group (LON:SMIN) subsidiary, which is slated for a spinout as a separately traded company next year, makes the infusion pumps and single-use cartridges for the PAH drug treprostinil, sold […]
Drug delivery tech dev Modular Medical raises $4m
Drug delivery tech developer Modular Medical has raised $4.2 million in a new round of equity financing, according to an SEC filing. The stealthy Escondido, Calif.-based company is developing a new medication delivery technology to “remove the burden of daily injections” and compliment individual lifestyles, according to its website. Read the whole story on our […]
Avanos Medical wins FDA nod for ON-Q Bolus pump
Avanos Medical (NYSE: AVNS), which rebranded from Halyard Health last June, said today that it won FDA 510(k) clearance for its ON-Q* with Bolus pump drug infusion device. The Alpharetta, Ga.-based company said that the new ON-Q* with Bolus system features improvements to improve ease of use and reduce postoperative opioid use for pain management. Read the whole story […]
FDA: West Pharma recall of Vial2Bag fluid transfer systems is Class I
The FDA recently labeled a select recall of West Pharmaceutical Services‘ (NYSE:WST) Vial2Bag fluid transfer systems over device functionality issues as Class I. Class I designations, the FDA’s most severe, are used when there is a reasonable probability that product use could cause serious adverse health consequences of death. The West Whiteland Township, Penn.-based company’s Vial2Bag […]
FDA warns on air embolism risk with infusion pumps, fluid warmers, rapid infusers
The FDA today released a medical device safety communication warning of air-in-line and air embolism risks, as well as the risks of false alarms for such events, associated with infusion pumps, fluid warmers and rapid infusers. The FDA reinforced the dangers of air-in-line issues, which can lead to potentially life-threatening air embolisms, but also warned […]
Gerresheimer’s Sensile Medical wins CE Mark for infusion pump
Gerresheimer subsidiary Sensile Medical said today it won CE Mark approval in the European Union for its wearable micropump intended for use in the treatment of Parkinson’s disease. The newly cleared device features automatic filling for use with liquid medicines, and includes a color display, charging unit and leather bag which allows the device to be worn […]
DHS warns on BD’s Alaris pump
The U.S. Dept. of Homeland Security issued an advisory this week, warning consumers that BD’s (NYSE: BDX) Alaris syringe pumps can be hacked via a vulnerability that gives a remote attacker unauthorized access to the device when it is connected to a terminal server. BD determined that the affected products are not sold within the U.S., the […]
Baxter wins CE Mark for Evo IQ infusion system
Baxter (NYSE:BAX) said today that its Evo IQ infusion system won CE Mark clearance and regulatory approval in Australia. The company plans to start the launch process for its infusion system in the U.K., Ireland, New Zealand and Australia in the third quarter of this year. Get the full story at our sister site, Drug Delivery […]
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