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 […]
Catheters
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 […]
Penumbra launches trial for Indigo blood clot aspiration device
Penumbra (NYSE:PEN) said today that it enrolled the first patient into its Cheetah study of the Indigo aspiration device. The Alameda, Calif.-based company said the Cheetah trial is slated to enroll up to 400 patients with coronary thrombus who are referred for percutaneous coronary intervention. The study’s primary endpoint is a composition of cardiovascular death, recurrent […]
BD to shutter Minnesota Lutonix plant, layoffs ahead for 53
Becton Dickinson (NYSE:BDX) is planning to close a Minnesota plant that makes its Lutonix drug-coated balloon next year, as the company looks to consolidate its peripheral intervention business. The decision means layoffs for 53 of the New Hope, Minn., site’s 85 workers; the remaining 32 employees will either move to roles at BD’s Tempe, Ariz., location […]
Medtronic recalls 6 French Sherpa NX active guide catheters
Medtronic (NYSE:MDT) said today that it recalled all models of its 6 French Sherpa NX active guide catheters due to a material problem that could result in exposed wires. The Fridley, Minn.-based company said the devices were recalled because of a risk of the outer material of the catheter separating from the device, resulting in detached […]
4C Medical pulls in $8m
4C Medical Technologies secured more than $8 million in an equity offering it hopes will reach the $20 million mark. The Maple Grove, Minn.-based company raised nearly $8.2 million in the offering, with $11.8 million remaining to be sold, according to an SEC Form D filed today. Forty-five unnamed investors have contributed to the offering. […]