LimFlow said today it raised $33.5 million (EU €27 million) in an oversubscribed Series C round of financing to support its technology designed to treat critical limb ischemia. The round was led by Sofinnova Partners and joined by existing investors BpiFrance and Balestier, the Paris-based company said. As part of the funding round, Sofinnova venture […]
Blood Management
Report: Theranos lays off most of its remaining workforce to stay afloat
Scandal-ridden blood testing company Theranos is laying off the majority of its workforce as it looks to stay afloat and delay bankruptcy for a few more months, according to a report from the Wall Street Journal posted on Tuesday. With the new layoffs, the company is reducing its headcount from approximately 125 employees to two […]
BD’s C.R. Bard must pay $4m in IVC bellwether
Becton Dickinson & Co.’s (NYSE:BDX) C.R. Bard (NYSE:BCR) is on the hook for $3.6 million in damages after a federal jury in Phoenix found Bard liable for damages caused by inferior vena cava filtering devices. The case is the first bellwether trial out of more than 3,000 suits which have been filed against Bard related to IVC […]
Wright launches Invision ankle revision, Prophecy preoperative nav systems in US
Wright Medical (NSDQ:WMGI) last week announced the US launch of its Invision total ankle revision system and Prophecy preoperative navigation planning system. The Memphis, Tenn.-based company touted the Prophecy preoperative navigation system as the first such system with patient specific instrumentation designed for ankle revision arthroplasty procedures. “Revision of a failed total ankle arthroplasty remains a […]
FDA clears Edwards Lifesciences hypotension index software
Edwards Lifesciences (NYSE:EW) said today it won FDA de novo approval for its Acumen Hypotension Prediction Index software designed to address potential hypotension in surgical patients. The Irvine, Calif.-based company said it is engaging in a targeted launch of the system in the US following the approval, which clears the software as an adjunctive predictive cardiovascular […]
8 women medtech innovators you need to know
As we celebrate more women becoming medtech leaders and paving the way for innovation, it’s important to remember the many accomplishments women have already made when it comes to the advancement of health and medicine. X-rays on the battlefield, the American Red Cross, leprosy treatment and more — these advances happened because of women. As […]
Cook Medical touts win in IVC filter bellwether
Cook Medical said today it won the second of three bellwether cases brought against it alleging that its inferior vena cava filters designed to capture and contain blood clots were defective. The Bloomington, Ind.-based company said that District Court Judge Richard Young entered a judgement in their favor on all of the plaintiffs claims against […]
SEC charges Theranos, CEO Holmes with ‘Massive Fraud’
The US Securities and Exchange Commission today charged controversial blood-testing developer Theranos, founder & CEO Elizabeth Holmes and former prez Ramesh Balwani with “massive fraud” – charges which Theranos and Holmes have agreed to resolve, according to the SEC. Charges include claims that the company raised more than $700 million from investors in “an elaborate, […]
LimFlow hopes to give end-stage CLI patients an alternative to amputation with its pDVA system
Earlier this year the FDA accepted LimFlow’s Percutaneous Deep Vein Arterialization system into its Breakthrough Device Program. CEO Dan Rose is hopeful that that designation, along with an increased feasibility study size, will help get the company’s pDVA product to critical limb ischemia patients in the US facing limb amputations with no other options. “There […]
Axiostat is India’s first entry on the U.S. hemostat market
Indian medical device maker Axio Biosolutions became the first Indian company with a wound care product cleared by the FDA, according to a press release from the company posted yesterday. The federal watchdog granted 510(k) clearance to Axio’s Axiostat chitosan hemostatic dressing, which is cleared as an over-the-counter product to stop external bleeding. The dressing […]
Perflow Medical closes $12m round to support Stream Net thrombectomy device
Israel-based neurovascular device developer Perflow Medical said it closed a $12 million round of financing to help support its Stream dynamic neuro-thrombectomy net designed for treating acute ischemic stroke. Funding from the round will support the European commercialization of the company’s first product, the Stream Net device, and a 510(k) submission to the FDA in […]