410 Medical announced that it received FDA 510(k) clearance for its LifeFlow device in the rapid delivery of blood and blood components. Durham, N.C.-based 410 Medical’s LifeFlow device is a rapid infuser designed to deliver one liter of crystalloid fluid through a 20-gauge IV catheter in five minutes for front-line treatment of patients needing urgent […]
BD has another Class I infusion device recall
The FDA issued another Class I recall designation for the BD Alaris from Becton Dickinson (NYSE:BDX), this time for potentially incorrect displays. Recalled products include the BD Alaris syringe module (model 8110) and BD Alaris PCA module (model 8120), and the BD Alaris syringe/PCA sizer sensor replacement kit (P/N 122786). Affected products related to the infusion […]
BD has a serious recall of some Alaris System infusion pumps with stuck keys
The FDA announced today that the August recall of a Becton Dickinson (NYSE:BDX) Alaris PC unit is Class I, the most serious kind. Initiated on Aug. 4, 2020, the recall pertains to the BD Alaris PC unit 8015 and five affected keypad replacement kits manufactured between April 7, 2017 and June 15, 2020 and distributed between […]
Concept Medical begins DCB trial for peripheral artery disease
Concept Medical announced today that it enrolled the first patient in its Future BTK trial for its peripheral artery disease (PAD) treatment. The first patient was enrolled in Singapore yesterday for the randomized, double-blind, placebo-controlled, multi-center trial for determining the effectiveness of the MagicTouch sirolimus coated balloon compared to standard balloon angioplasty in treating below […]
CHF Solutions closes $14.4M offering
CHF Solutions (NSDQ:CHFS) announced that it closed an underwritten public offering worth gross proceeds of approximately $14.4 million. Eden Prairie, Minn.-based CHF Solutions’ offering includes the full exercise of the underwriters’ over-allotment option to purchase additional shares and warrants, bringing the total proceeds to $14.37 million after the offering was priced last week at approximately $12.5 […]
FDA grants EUA to convalescent plasma
The FDA yesterday granted emergency use authorization (EUA) for investigational convalescent plasma in treating hospitalized COVID-19 patients. According to the FDA, the product may be effective in treating the virus and its known and potential benefits outweigh the known and potential risks, based on available scientific evidence. The announcement came amid pressure put on the […]
BD says 3 serious issues related to Alaris recall
Becton Dickinson (NYSE:BDX) today offered an update confirming three separate issues related to the recall of its BD Alaris infusion pumps. Three situations described in the recall, which was announced on June 30, were designated as FDA Class I recalls (the most serious kind), meaning that there is reasonable probability that use of the product will […]
CHF Solutions prices $12.5M offering
CHF Solutions (NSDQ:CHFS) announced today that it priced an underwritten public offering of units worth approximately $12.5 million. Each unit in the offering consists of one share of common stock and one warrant to purchase one share of common stock at a public offering price of 45¢ per share, which expires on the fifth anniversary […]
NIH puts $4.3M into convalescent plasma trial for COVID-19 treatment
The National Institutes of Health today awarded the Albert Einstein College of Medicine and Montefiore a $4.3 million grant to test plasma in treating COVID-19. Einstein and Montefiore launched a Phase 2 clinical trial to evaluate the efficacy of convalescent plasma in treating COVID-19 in April. The $4.3 million will support the randomized, double-blind, placebo-controlled […]
FDA clears Masimo index to better track ventilated patients
Masimo (NSDQ:MASI) announced today that it received FDA clearance for its PVi for fluid responsiveness indication in ventilated adult patients. PVi (pleth variability index) now has indication as a continuous, non-invasive, dynamic indicator of responsiveness in select populations of mechanically ventilated adult patients, as it measures dynamic changes in the perfusion index that occur during the […]
Baxter gains EUA for renal replacement tech for critically ill children
Baxter (NYSE:BAX) announced today that it received FDA emergency use authorization (EUA) for its HF20 Set and ST Set for continuous renal replacement therapy (CRRT). Under EUA, the HF20 Set can deliver CRRT to treat patients of low weight (8-20 kg) and low blood volume who can’t tolerate a larger extracorporeal circuit volume in an acute […]
- 1
- 2
- 3
- …
- 40
- Next Page »
