Abiomed (NSDQ:ABMD) said today it submitted PMA applications to expand indications for its Impella line of percutaneous micro heart pumps to patients suffering cardiogenic shock following acute myocardial infarction or cardiac surgery. In addition to the new indication, the Danvers, Mass.-based company also submitted an application for longer duration use, Abiomed said. The submissions include a […]
Blood Management
Aethlon plans IDE, slims losses on Q1 report
Aethlon Medical (OTC:AEMD) yesterday said it plans to file for Investigative Device Exemption status for its HemoPurifier after the company’s contract with DARPA expires, and reports slimmed losses for the company and investors. In a quarterly earnings call, CEO Jim Joyce said this would be the company’s last year on contract with DARPA, with a caveat of a […]
Haemonetics launches HaemoCloud
Haemonetics (NYSE:HAE) said today it launched the HaemoCloud software platform designed to connect all of Haemonetics devices and software. The HaemoCloud includes software which allows the company’s blood management devices to connect to hospital IT systems and provides real-time data for service and support, the Braintree, Mass.-based company said. “As the healthcare industry transitions from analog to […]
Terumo BCT wins FDA nod for Trima Accel
Terumo Corp.‘s (TYO:4543) BCT subsidiary said today it won FDA 510(k) clearance for a labeling change of its Trima Accel automated blood collection system. The updated classification extends the Trima Accel’s ability to store platelets in plasma from 5 days to 7, as well as operating with updated wireless capabilities, the company said. “Collaborating with customers […]
NxStage teases at new pipeline products, announces Q2 earnings
NxStage Medical (NSDQ:NXTM) yesterday celebrated the 10 year anniversary mark for FDA approval of its System One home hemodialysis, announced new pipeline developments and Q2 earnings that beat expectations. The pipeline announcements from Lawrence, Mass.-based were said to include a next generation hemodialysis system, peritoneal dialysis system and a new critical care system, the company said. “Over […]
Haemonetics fiscal Q1 earnings top expectations
Haemonetics (NYSE:HAE) today reported fiscal 1st quarter earnings that topped analyst expectations, while missing revenue marks. The Braintree, Mass.-based company reported a net loss of $267,000, a loss of 1¢ per share, on sales of $213.4 million for the 3 months ending June 27. The company pared its losses by 92.7% as it saw sales shrink 5.1% […]
St. Teresa Medical launches Surgiclot system
St. Teresa Medical said yesterday it enrolled the 1st patient in a clinical trial of its Surgiclot clotting bandage. The company won approval for a 40-patient study of Surgiclot from the U.K.’s Medicines and Healthcare products Regulatory Agency in June, St. Paul, Minn.-based St. Teresa said. The 1st surgery using the bandage dressing was performed earlier […]
Masimo renews $1m oximeter challenge
Masimo (NSDQ:MASI) said yesterday it is renewing a $1 million challenge made originally in 2013 that its SET pulse oximeter will outperform its device equivalent from competitor Nellcor, now owned by Medtronic (NYSE:MDT). If a hospital can prove in a head-to-head comparison that Masimo’s SET pulse oximeter is inferior to Nellcor’s device, Irvine, Calif.-based Masimo will pay […]
Thoratec wins CE Mark for HeartMate PHP
Thoratec (NSDQ:THOR) said today it won CE Mark approval in the European Union for its HeartMate percutaneous heart pump. Approval was based on data from the 1st 30 patients enrolled in its Shield I CE mark trial, the Pleasanton, Calif.-based company said. Data from all 50 patients in the study is slated to be presented later this […]
Aethlon lists on NASDAQ
Aethlon Medical (OTC:AEMD) said yesterday that the NASDAQ Stock Market has approved its application to begin trading on the Nasdaq Capital Market, beginning July 13. The company’s shares will be traded on the Nasdaq Capital Market under its existing trading symbol AEMD, the San Diego, Calif.-based company said. “Trading on Nasdaq is a pivotal corporate […]
Aethlon announces $6m follow-on offering
Aethlon Medical (OTC:AEMD) said today that it looks to raise $6m with a stock offering at $6.30 per share, including a 5-year warrant allowing the purchase of up to 3 shares per 4 shares purchased in this offering. Aethlon is authorized to issue up to 10 million shares, with funds slated for the clinical advancement of the […]