Haemonetics (NYSE:HAE) said on Monday that it won expanded FDA 510(k) clearance for its TEG 6s hemostasis analyzer system, now indicated for use in adult trauma settings. The TEG 6s system is comprised of an analyzer, disposable cartridges and software and is intended to provide a rapid and accurate identification of a patient’s hemostasis condition, the […]
Haemonetics deals S.C. plant to CSL Plasma for $10m
Haemonetics (NYSE:HAE) said today that it agreed to sell a plant in South Carolina to CSL Plasma for $10 million. The Union, S.C., facility makes the liquid saline and sodium citrate solutions used in plasma collection. CSL Plasma, the supplier for CSL Behring, will own and operate the plant, taking on “substantially all” of the roughly […]
Velano Vascular raises $10m
Velano Vascular said today that it raised $10 million in a new round of financing to support its novel vascular access solutions. The round was joined by strategic investor Intermountain Healthcare, Kapor Capital, Marc Benioff, former Baxter International CEO Robert Parkinson and former BD CEO Edwards Ludwig, the San Francisco-based company said. Velano said that […]
Blood collection tech dev Boston Microfluidics raises $18m
Blood collection and testing tech developer Boston Microfluidics has raised approximately $17.6 million in a new round of equity financing, according to a recently posed SEC filing. The Boston-based company’s offerings include the Stick self-collection device, a product intended to allow an average user to collect clinical-grade blood samples without a phlebotomist. The device is […]
FDA plans May advisory panel meeting for surgical staplers, absorbable hemostatics
UPDATED April 24, 2019, with further detail on the FDA’s actions. The FDA today scheduled an advisory committee meeting next month to consider its proposal to strengthen the regulation of surgical staplers. During the meeting, set to take place May 30-31, the FDA will seek the committee’s input on its plan to shift surgical staplers […]
CMS proposes improved ambulatory BP coverage
The U.S. Centers for Medicare & Medicaid Services recently released a proposed decision memo stating that it believes there is evidence sufficient to support the use of ambulatory blood pressure monitoring for diagnosing and treating hypertension in its beneficiaries. The agency laid out circumstances for reimbursement coverage, including white coat hypertension verified through at least […]
Loop Medical lands $3.2M grant for blood collection device
Loop Medical said today that it has received a $3.2 million grant from the Bill & Melinda Gates Foundation to support pre-production and clinical trials required for the global registration of its blood collection device. The foundation had previously given the company a $400,000 grant. Based at the Swiss Institute of Technology (EPFL) in Lausanne, […]
Report: Drones are delivering blood samples in N.C.
Autonomous drones have begun to ferry blood samples between clinics and labs in the skies over North Carolina, according to a recent report from Wired. The drone service, run by UPS with drone technology from Matternet, made its first flight last Tuesday at Raleigh’s WakeMed Hospital, according to the report. The drone can carry up […]
UPDATE: Magnolia Medical files another suit against Kurin
Updated to include a response from Kurin. Magnolia Medical Technologies said yesterday that it filed another legal action against blood-culture-focused device developer Kurin, this time claiming the company has infringed on patents related to its Steripath technology. The Seattle-based company asserts that Kurin is infringing upon four patents related to its Steripath blood collection technology […]
Tasso lands $6m to launch home blood-collection device
Blood-collection startup Tasso said it has completed a $6.1 million financing round led by Vertical Venture Partners (VVP), with participation from Techstars and Cedars-Sinai. The funding will help Tasso scale its first product, Tasso OnDemand, which enables self-collection of blood samples, and to add personnel to support commercial growth. Tasso OnDemand allows people to collect blood at home […]
Fresenius launches 2008T BlueStar hemodialysis machine in U.S.
Fresenius Medical Care (NYSE:FMS) said today that it launched its 2008T BlueStar hemodialysis machine, touting more than 30 improvements from previous device models. The Waltham, Mass.-based company said that the new system is intended to allow for simpler operation and maintenance with additional treatment options, and added that the system features a number of newly automated technologies. […]
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