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 […]
Cook Medical touts launch, first use of Advance CS, Compass CT systems
Cook Medical today announced the launch and first use of its Advance CS coronary sinus infusion catheter and Compass CT disposable pressure transducer designed for treating heart failure patients. The CS catheter is a percutaneous balloon infusion catheter designed for use in retrograde coronary sinus infusion procedures to infuse therapeutic agents into the heart via the […]
AcelRx tackles acute pain with sublingual drug-delivery tech
While pain medicine specialist Dr. Pamela Palmer was working at the University of California-San Francisco, she noticed something peculiar was happening to patients undergoing surgery – many who survived their procedures were dying of opioid overdoses as a result of patient-controlled drug pumps. “The nurse has to program a number of parameters into it and, […]
Report: J&J’s Cerenovus to discontinue Codman liver cancer pump
Johnson & Johnson‘s (NYSE:JNJ) Cerenovus is discontinuing production of Codman pumps designed to deliver targeted chemotherapy to the liver for patients with liver cancer, according to a New York Times report. The devices are designed to be implanted in the abdomen to deliver chemotherapy directly to the liver to treat cancer that has spread to […]
Smiths updates recall for Medfusion syringe pumps
Smiths Medical has amended an urgent medical device recall that it first issued in August for its Medfusion syringe pump model series 3500 and 4000. After acknowledging that a defect in certain models of the pump can cause an “invalid syringe size” alarm to go off, the company added an option for facilities with trained staff […]
Spectral Medical wins FDA nod for Spectral Apheresis Machine
Spectral Medical (TSX:EDT) said this month it won FDA 510(k) clearance for its Spectral Apheresis Machine designed for use in continuous renal replacement therapy and therapeutic plasma exchange. The SAM device was developed to support commercialization of the company’s Toraymyxin, or PMX therapy, to enable intensive care units to be able to safely and efficiently deliver […]
CareFusion warns customers about Alaris syringe pump alarm
CareFusion issued a warning to customers of its Alaris syringe drug pump system, cautioning them that pumps made before 2008 may display an error message that could stop the pump from working. The company wrote that it has received a report from a customer that the device displayed a re-occurring internal malfunction error code, PL3, which […]
Medtronic retools SynchroMed II infusion pump
Medtronic (NYSE:MDT) said this month that it won approval for a change to its problematic SynchroMed II implantable drug infusion pump designed to address motor shaft wear issues. The Fridley, Minn.-based medical device titan said the change is aimed at improving the long-term rate of non-recoverable motor stall in the SynchroMed II devices, estimating that pump […]
Repro-Med clears FDA warning letter, shuffles C-suite
Repro-Med Systems (OTC:REPR) said last week that the FDA cleared a 2016 warning letter for its Freedom 60 syringe infusion pump and Freedom Edge infusion pump and made some changes in the executive suite. Repro-Med, which does business as RMS Medical Products, said the closure of the warning letter stemmed from its successful bid for 510(k) clearance […]
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