Cordis earned FDA approval for its Selution SLR (sustained limus release) drug-eluting balloon (DEB) to treat coronary in-stent restenosis, the device developer announced today. “As the first and only sirolimus drug-eluting balloon approved in the United States, Selution SLR DEB introduces a groundbreaking therapy for the treatment of coronary … [Read more...] about Cordis earns FDA nod for Selution SLR drug-eluting balloon
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Boston Scientific discontinues Imager II angiographic catheter sales
Boston Scientific recalled and discontinued all Imager II angiographic catheters due to a manufacturing issue, according to an FDA early alert. Imager II angiographic catheters are diagnostic intravascular catheters used to capture images of the patient’s peripheral vasculature. Boston Scientific determined the catheters were “manufactured … [Read more...] about Boston Scientific discontinues Imager II angiographic catheter sales
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
FDA warns on percutaneous catheter issue from Boston Scientific
The FDA today issued an early notice after Boston Scientific (NYSE:BSX) recommended the removal of certain percutaneous catheter systems. In a letter dated July 9, 2026, Boston Scientific told customers to identify affected EnRoute transcarotid neuroprotection system (NPS) and EnRoute NPS Plus products and cease use and distribution. Customers … [Read more...] about FDA warns on percutaneous catheter issue from Boston Scientific
Baxter warns on intravascular administration sets
The FDA issued an early alert after Baxter (NYSE:BAX) recommended the removal of certain Duo-Vent intravascular administration sets. Baxter sent all affected customers a letter on June 30, telling them to immediately identify, quarantine and return affected lots. The communication affects lots DR26C27062, DR26D14031 and DR26E13055 of the … [Read more...] about Baxter warns on intravascular administration sets
Medtronic warns on Harmony transcatheter pulmonary valve delivery system
Medtronic (NYSE:MDT) has issued a letter to affected customers recommending the removal of certain lots of its Harmony delivery catheter system (DCS). In a notice published by the FDA, the agency said Medtronic's recall involves removing certain devices from where they are used or sold. The FDA identified it as the most serious type, as it could … [Read more...] about Medtronic warns on Harmony transcatheter pulmonary valve delivery system
Abbott gets FDA nod for longer length Esprit BTK drug-eluting scaffold
Abbott (NYSE:ABT) announced today that the FDA approved the longer length (76 mm) Esprit BTK drug-eluting scaffold system. The longer Esprit BTK system received approval for the treatment of chronic limb-threatening ischemia (CLTI), a severe form of peripheral artery disease (PAD). CLTI can cause extreme pain, open wounds that don’t heal and, … [Read more...] about Abbott gets FDA nod for longer length Esprit BTK drug-eluting scaffold
Johnson & Johnson wins FDA approval for ThermoCool SmartTouch dual-energy ablation system
Johnson & Johnson (NYSE:JNJ) announced today that it received FDA approval for its dual-energy ThermoCool SmartTouch SF platform (DE STSF). The ThermoCool SmartTouch platform combines the ThermoCool SmartTouch SF catheter with the TruPulse generator. Combining the irrigated contact-force-sensing catheter with TruPulse enables the delivery of … [Read more...] about Johnson & Johnson wins FDA approval for ThermoCool SmartTouch dual-energy ablation system
xDot Medical can begin FDA IDE study of vascular closure device
xDot Medical announced today that it received FDA investigational device exemption (IDE) approval for its access management system (AMS). IDE approval enables the company to initiate a pivotal clinical trial evaluating the AMS for the closure of femoral arterial and femoral venous access sites. The company plans to enroll patients undergoing … [Read more...] about xDot Medical can begin FDA IDE study of vascular closure device
Penumbra wins FDA clearance for Thunderbolt computer-assisted vacuum thrombectomy for stroke
Penumbra (NYSE:PEN) announced today that it received FDA clearance for its Thunderbolt thrombectomy platform for stroke. Thunderbolt expands the Alameda, California-based company's computer-assisted vacuum thrombectomy (CAVT) portfolio. It aims to address acute ischemic stroke. Penumbra said Thunderbolt represents a first-of-its-kind … [Read more...] about Penumbra wins FDA clearance for Thunderbolt computer-assisted vacuum thrombectomy for stroke
