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. […]
Getinge shares drop on news of more deaths, injuries linked to faulty IABPs
Shares of Getinge (STO:GETI-B) dropped 5% today on news that the FDA had received 60 more reports of adverse events — including two deaths and one serious injury — related to the company’s Maquet/Datascope intraortic balloon pumps (IABP). The FDA said the new reports have come in since it issued a letter in November 2018 […]
Edwards issues recall for Pascal guide sheaths
Edwards Lifesciences (NYSE:EW) issued a product recall for its guide sheath used with the Edwards Pascal transcatheter valve repair system. The company is recalling all lots of the product after it identified potential for damage to the Pascal guide sheath’s inner line due to a manufacturing issue. Edwards found that the issue has occurred in 0.5% […]
Shockwave Medical prices $75 million offering
Shockwave Medical (NSDQ:SWAV) filed a common stock equity offering with the SEC priced at $75 million. The Santa Clara, Calif.–based company said in yesterday’s filing that at the assumed public offering price of $36.14 that was reported on Nov. 11, it expects to offer nearly 2.1 million shares of common stock. Shockwave said it anticipates approximately […]
Coating snafu prompts recall of some Boston Scientific balloon catheters
Boston Scientific (NYSE:BSX) is voluntarily recalling certain dilation and extension catheters after finding that specific batches may have missed the hydrophilic coating step in the manufacturing process. That step is supposed to create a lubricious surface on the devices. Use of a catheter affected by the missed step could boost friction during delivery and withdrawal, delaying […]
Internal probe finds major problems at Ra Medical
Ra Medical Systems (NYSE:RMED) said yesterday that an internal investigation found failures surrounding its Dabra laser catheters among other shortcomings. The Carlsbad, Calif.-based company announced the investigation in August after allegations were raised by an employee and additional issues were uncovered over time. In the same announcement, the company ousted CEO, co-president & CTO Dean Irwin […]
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