Abbott (NYSE:ABT) said today that U.S. FDA has approved a clinical trial to study the effectiveness of its MitraClip transcatheter mitral valve repair device in people eligible for open-heart surgery. The MitraClip has been available in the U.S. since 2013 and Europe since 2008 — but is only indicated as an option for people who don’t have […]
Pavmed back in NASDAQ compliance
Pavmed (NSDQ:PAVM) said today that it has received formal notice from NASDAQ that it has returned to compliance with the stock exchange’s listing rule after 10 consecutive days with a closing bid price of at least $1 per share. NASDAQ warned the company in November that it was in danger of delisting due to poor […]
Adagio Medical starts iCLAS AFib trial
Adagio Medical announced that it enrolled the first patient in its iCLAS investigational device exemption clinical trial for assessing the treatment for persistent atrial fibrillation. The iCLAS is a low-temperature intelligent continuous legion ablation system. The FDA-approved study has the goal of evaluating the safety and efficacy of the system in PsAF to support pre-market approval […]
Velano Vascular adds $25m for $50m total
Velano Vascular announced today that it closed the second tranche of a $25 million growth financing to bring its total funding to more than $50 million. The total funding collected from insiders, venture capital firms, hospital partners and undisclosed healthcare industry multinationals is earmarked for Velano’s planned commercialization and the launch of additional inpatient medical […]
Cook Medical issues Class I recall of CrossCath Support Catheters
Cook Medical is recalling its CrossCath Support catheters due to potential marker bands dislodging or buckling in a Class I recall. Cook Medical said an error occurred during manufacturing that could cause radiopaque marker bands to be too loose on some CXC3.0 CrossCath Support Catheters and could be too tight on certain CXC3.4 CrossCath Support […]
W.L. Gore officials think they can spur insulin delivery system innovation
W.L. Gore announced this week that it is investing in PhysioLogic Devices, a startup developing an implantable intraperitoneal insulin delivery system. The size of the investment was not disclosed. But it was part of Gore’s Micro-Equity Investment (MEI) program, which provides investments of up to $500,000. W.L. Gore officials think the company’s more than 60 years […]
Edwards projects $5 billion in sales for 2020
Wall Street expressed brief unhappiness with projections made at today’s Edwards Lifesciences (NYSE:EW) annual investor conference in New York, but shares had recovered partially by the close of trading. The Irvine, Calif.-based heart valve replacement pioneer projected adjusted EPS of $6.05 to $6.30 on global sales of $4.5 billion to $5 billion for 2020. Edwards […]
FDA: Abiomed Impella RP survival rate steady when appropriate patients are implanted
The survival rate of right-heart failure patients treated with the Abiomed (NSDQ:ABMD) Impella RP heart pump remained about the same during the latest round of post-approval studies, according to the FDA. That latest rate of survival 30 days post-explant, post-discharge survival or switch to another therapy rate was 72.7%, or 16 out of 22 patients among […]
Ra Medical shares begin recovery following report of Q3 losses, material weakness
Ra Medical Systems (NYSE:RMED) reported third-quarter losses of $17.4 million last week amidst an internal investigation into failures surrounding its Dabra laser catheters and other shortcomings. That investigation, announced in August, recently revealed deficiencies in its internal controls that constitute a material weakness and could have resulted in material misstatements or omissions to its financial statements […]
Coloplast recalls stents due to package sterility issue
Coloplast (CPH:COLO-B) recalled nine total batches of its Biosoft Duo double loop ureteral stent kit and Vortek double loop ureteral stent kit due to a packaging anomaly. Humlebaek, Denmark–based Coloplast issued an urgent field safety notice out of Germany earlier this month to warn users of the packaging issue and instruct them to review stock and […]
Everything you need to know about medical device creation
Medtech development is hard. Medical device creation can require manufacturing know-how in areas as wide-ranging as electrical components, high-performance polymers, molding and machining – and that doesn’t even include the required expertise in design, regulatory requirements and achieving reimbursement. The good news is that the companies serving the medical device industry have become specialized experts. […]
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