Becton Dickinson‘s (NYSE: BDX) life sciences division issued a recall last month for some of its blood collection tubes, citing a manufacturing flaw that resulted in devices without sufficient additive. The company explained that an internal investigation found that Vacutainer Citrate Plus tubes with too little additive led to falsely-shortened clotting time and could impact patient […]
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
Fine-tuning formulation with Fluid Imaging Technologies’ FlowCam
After seven people died in 2013 from serious allergic reactions to Omontys, an injectable anemia drug marketed by Takeda Pharmaceutical (TYO:4502) and Affymax, the companies recalled the product and regulators launched an investigation to find out the cause of such an unexpected rate of anaphylaxis. Omontys was made and cleared in a single-use vial and a multi-use […]
7 medtech stories we missed this week: April 6, 2018
From CHF Solutions’s distribution deal to Guided Therapeutics’s licensing agreement, here are seven medtech stories we missed this week but throught were still worth mentioning. 1. CHF inks Spanish distribution deal CHF Solutions announced in an April 5 press release that it has signed a distribution agreement with Dimedix Surgical. The distribution agreement will allow […]
Cardiva Medical wins expanded FDA indications for Vascade vascular closure system
Cardiva Medical said today it won expanded indications from the FDA for its Vascade vascular closure system, now cleared for use in 5-7F femoral venous closures in addition to arterial closure. The Vascade system is composed of a thrombogenic bioabsorbable collagen patch and a collapsible mesh disc, the Santa Clara, Calif.-based company said. The device functions by […]
CurveBeam wins CE Mark for LineUP, InReach ortho CTs
Medical imaging device developer CurveBeam said yesterday it won CE Mark approval in the European Union for its LineUP and InReach orthopedic extremity computed tomography scanning systems. The Warrington, Penn.-based company said its LineUP system is designed to allow the patient to stand during scanning to assess weight-bearing or load-bearing positions, and can perform bilateral scans […]
Siemens wins FDA nod for Somatom Edge plus CT scanner
Siemens (NYSE:SI) Healthineers said today that it won FDA clearance for its Somatom Edge plus computed tomography machine. The company said the newly cleared device features its FAST integrated workflow and FAST 3D camera, which it claims is the first patient positioning system powered by artificial intelligence. The scanner also includes automated scan preparation and customized patient […]
Abiomed wins CE Mark for Impella 5.5
Abiomed (NSDQ:ABMD) said today that it won CE Mark approval in the European Union for its Impella 5.5 heart pump, saying that the first patient in Europe has already been treated with the device. The Danvers, Mass.-based company said that Dr. Alexander Bernhardt, under the guidance of Dr. Hermann Reichspurner, performed the first procedure in the […]
Curetis wins FDA nod for respiratory infection diagnostic system
Molecular diagnostics company Curetis said today that it won a de novo clearance from the FDA for its Unyvero System and lower respiratory tract infection cartridge. Combined with the cartridge, the Unyvero System evaluates samples for the presence of infectious respiratory disease in under five hours. The device can also tell doctors if it detects any genetic antibiotic resistance […]
Gore wins expanded indications for Cardioform septal occluder
W.L. Gore & Associates said today it won expanded FDA indications for its Cardioform septal occluder, now cleared for the closure of patent foramen ovale to reduce the risk of recurrent ischemic stroke in certain patients. The expanded application was supported by results from the Reduce study, which the Newark, Del.-based company said showed that […]
AstraZeneca’s once-weekly diabetes drug wins expanded FDA approval
AstraZeneca (NYSE:AZN) said today that the FDA approved its extended-release formulation of exenatide, Bydureon, for use as an add-on therapy to basal insulin in adults with Type II diabetes. The company’s once-weekly GLP-1 injectable was first approved in the U.S. in 2012. Get the full story at our sister site, Drug Delivery Business News.
FDA clears Adherium’s inhaler sensor for OTC sales
The FDA gave Adherium (ASK:ADR) the go-ahead to launch over-the-counter sales of its Smartinhaler sensor for AstraZeneca‘s (NYSE:AZN) Symbicort asthma inhaler, the company touted last week. Adherium’s product installs directly onto a patient’s inhaler to monitor and boost medication adherence. The device records the time and date that a patient uses their inhaler and transmits […]