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 […]
Catheters
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 […]
Abiomed jumps on fiscal Q2 earnings beat
Abiomed (NSDQ:ABMD) shares got a pre-market jump today from fiscal second-quarter earnings that topped the consensus forecast once some $35 million in unrealized losses from its stake in Shockwave Medical (NSDQ:SWAV) were factored in. The Danvers, Mass.-based heart pump maker posted profits of $13.1 million, or 28¢ per share, on sales of $205.0 million for […]
Abbott plans $38m Mitraclip plant in Indiana
Abbott (NYSE:ABT) announced yesterday that it plans to spend close to $38 million to open a manufacturing plant for its Mitraclip system in Westfield, Ind. The proposed 120,000-square-foot facility in Westfield’s NorthPoint Industrial Park could cost more than $37.6 million and is slated to employ as many as 477 people by the end of 2024, according […]
BD warns of international device shortages in EO plant legal filing
The Georgia environmental chief’s effort to shut down a Becton Dickinson (NYSE:BDX) medtech sterilization plant could cause widespread shortages of commonly used devices for which BD has a large market share, the company said today in a court filing. On Tuesday, Georgia state Environmental Protection Division director Richard Dunn filed a motion with Newton County Superior Court […]
FDA warns of device shortages again due to sterilization plant closures
The FDA today warned of “years of spot or nationwide shortages” of a number of surgical kits and implantable medical devices due to the closure of two medtech sterilization plants that use ethylene oxide (EO) and efforts in Georgia to close a third. Potentially affected surgical kits include those used in emergency Caesarean sections and […]
Verix Health lands $8m Series A for steerable devices
Verix Health said today that it closed a Series A round worth $8 million for the steerable devices it’s developing. Santa Clara, Calif.-based Verix said Ajax Health led the round, which included Aperture Venture Partners and Western Technology Investment. The funds are earmarked for R&D and preparations for commercialization for the steerable devices, which are […]
Acutus, Innovative Health ink EP deal
Acutus Medical and Innovative Health this week announced a partnership that will combine the companies’ portfolios of electrophysiology products. The companies plan to work together to gain clearances, market products and rein in per-procedure costs while using hospital money for emerging technologies, according to a news release. Recognizing the constraints that hospitals and health systems […]