Abbott (NYSE: ABT) earned FDA approval for its new dual-energy catheter, TactiFlex Duo sensor-enabled ablation catheter. TactiFlex Duo joins Johnson & Johnson MedTech’s ThermoCool SmartTouch SF and Medtronic's Affera Sphere-9 catheter in the U.S. dual-energy ablation catheter market. Medtronic won its Sphere-9 approval in 2024, and J&J … [Read more...] about Abbott earns FDA approval for new dual-energy ablation catheter
Tubing Components
FastWave Medical earns FDA IDE approval for next-gen IVL system
FastWave Medical earned FDA investigational device exemption (IDE) approval for its next-generation intravascular lithotripsy (IVL) technology, the company announced today. The approval clears the company to begin a U.S. pivotal trial of its Artero electric IVL system designed to treat peripheral artery disease. "Reaching IDE approval takes a … [Read more...] about FastWave Medical earns FDA IDE approval for next-gen IVL system
FDA issues Class I recall for Hamilton Medical ventilator components
The FDA issued a Class 1 recall for certain Hamilton Medical coaxial breathing circuit sets after reports of four serious injuries. Hamilton Medical said certain lots of coaxial breathing circuit sets used with its Hamilton-C1, Hamilton T-1 and Hamilton-MR-1 ventilators are preassembled with an expiratory valve set that doesn’t perform as … [Read more...] about FDA issues Class I recall for Hamilton Medical ventilator components
Penumbra launches next-gen Lightning Flash 3.0 thrombectomy system
Penumbra (NYSE:PEN) announced today that it launched the Lightning Flash 3.0 computer-assisted vacuum thrombectomy (CAVT) system. The latest-generation Lightning Flash CAVT offering includes significant upgrades, advancing Penumbra's venous thromboembolism (VTE) platform, the company says. Penumbra — which is set to be acquired by Boston … [Read more...] about Penumbra launches next-gen Lightning Flash 3.0 thrombectomy system
Vantive updates instructions after dialysis system tubing issue
The FDA issued a notice related to updated instructions for the Vantive Prismaflex control units after reports of a potential tubing issue. Vantive, the former kidney care unit of Baxter, issued a letter on Jan. 6 informing customers of the updated instructions. The FDA said it became aware of the "potentially high-risk device issue" related to … [Read more...] about Vantive updates instructions after dialysis system tubing issue
BD warns on esophagogastric balloon tamponade tubes after death
The FDA issued a notice highlighting a letter issued by BD and its C.R. Bard Urology and Critical Care subsidiary warning of new balloon device instructions. This warning follows one death associated with the device issue. BD sent affected customers a notice updating instructions for all lots of certain esophagogastric balloon tamponade tubes. … [Read more...] about BD warns on esophagogastric balloon tamponade tubes after death
BD warns on intravascular catheter
The FDA shared an alert that BD (NYSE: BDX) and its Bard subsidiary warned customers of an issue with certain intravascular catheters. BD recommended the removal of certain unused PowerPICC intravascular catheters from use or sale. In-use PowerPICC intravascular catheters also received updated instructions for use. Affected products include the … [Read more...] about BD warns on intravascular catheter
FTC challenges private equity firm’s acquisition of Surmodics
The U.S. Federal Trade Commission (FTC) has sued to block the planned acquisition of medical device company Surmodics by GTCR. According to a news release, GTCR also owns a majority stake in Biocoat. The FTC says Biocoat is the second-largest provider of outsourced hydrophilic medical device coatings, behind only Surmodics. As a result, the FTC … [Read more...] about FTC challenges private equity firm’s acquisition of Surmodics
Olympus has a serious endoscope guide sheath recall
The FDA today issued a notice warning of the removal of certain single-use guide sheath kits for endoscope instruments by Olympus. This recall involves removing certain devices from where they are used or sold. The FDA identified it as the most serious type of recall, as it may cause serious injury or death. Olympus warned customers to not … [Read more...] about Olympus has a serious endoscope guide sheath recall
Freudenberg Medical is getting a new CEO
NEWS RELEASE: CEO transition at Freudenberg Medical Beverly, Massachusetts – Freudenberg Medical, a global contract design, development and manufacturing partner to the medical device and biopharma industry, has announced a strategic leadership transition. Effective Jan. 1, 2025, Michael McGee, former COO, assumed the role of chief executive … [Read more...] about Freudenberg Medical is getting a new CEO
