Boston Scientific recalled all unused Infinion CX leads used in its spinal cord stimulator systems (SCS) after identifying an issue that could result in “high impedance measurements or lead fractures,” the company said. The company said the lead body could experience mechanical stress at the anchor site, which could cause the abnormal impedance measurements or […]
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
Globus Medical wins CE mark for Excelsius3D imaging system
Globus Medical (NYSE: GMED) has secured a CE mark for its Excelsius3D intelligent 3-in-1 imaging system for spine and cranial procedures. The regulatory approval in the EU, announced yesterday, comes five years after the system’s FDA clearance in the U.S. With a CE mark, Audubon, Pennsylvania–based Globus kicks off commercialization of Excelsius3D in the European […]
Medtronic says Endurant stent graft’s new CE mark could boost use for ruptured AAA
Medtronic (NYSE: MDT) has secured a CE mark for its Endurant stent graft, removing a treatment warning related to its use in ruptured abdominal aortic aneurysms (AAA). The Minnesota-run medtech giant received a similar FDA labeling change in late 2025. A ruptured AAA occurs when the main artery in the abdomen bursts, causing severe internal […]
Boston Scientific recalls, discontinues 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 with reduced levels of stabilizing agents in the tips,” according […]
MicroPort’s covered stent system receives special review in China
MicroPort Coronary announced that its FireShield coronary covered stent system will undergo the National Medical Products Administration (NMPA) special review procedures in China. The special review procedures aim to accelerate review for innovative medical devices that meet criteria for domestic originality, technical novelty and clinical value. (The FDA Investigational Device Exemption program plays a similar […]
GE HealthCare’s Photonova Spectra system receives CE mark
GE HealthCare announced it has received the CE Mark for its Photonova Spectra system, a photon-counting computed tomography (PCCT) system integrated with the company’s Deep Silicon detector technology. The system provides on-demand spectral and spatial imaging for every scan, and its ultra-high definition (UHD) imaging is “designed to work with wide coverage,” the company said. […]
MiniMed wins CE mark for next-gen insulin pump, ups revenue guidance
MiniMed (Nasdaq: MMED) today reported Street-beating first-quarter revenue, upping its full-year sales guidance as it notched an early European regulatory win. The Northridge, California–based diabetes tech company, spun out of Medtronic earlier this year, announced a CE mark for its next-gen, app-controlled MiniMed Flex insulin pump — well ahead of the company’s calendar 2026 year-end target. […]
Medtronic recalls reflux testing system after 184 serious injuries
Medtronic initiated a global voluntary recall for certain lots of its Bravo calibration-free (CF) reflux testing system after reports of 184 serious injuries associated with a deployment control problem. Medtronic recalled the device “due to a risk of attachment and detachment issues related to the system’s delivery system,” a Medtronic spokesperson told MassDevice. “To ensure […]
Johnson & Johnson’s Abiomed recalls Automated Impella Controllers after 3 patient deaths
Johnson & Johnson’s Abiomed recommends customers remove all Automated Impella Controllers (AICs) from where they’re used or sold after 37 reports of serious injuries and three deaths were linked to component failures. Abiomed identified purge cassette recognition issues “resulting from failures of the purge flag component within the purge pressure sensor assembly.” J&J issued the […]
Paradromics gets FDA nod to expand BCI compatibility to personal devices
Paradromics received FDA approval to expand the types of computing devices that could be used with its investigational brain-computer interface (BCI) system, the company told MassDevice. “This FDA approval clears a path for our software to work on the everyday devices people already rely on – laptops, tablets, phones – so that a brain-computer interface […]
Abbott’s next-generation Amulet LAA occlusion device earns CE Mark
Abbott’s (NYSE: ABT) Amulet 360 left atrial appendage (LAA) occlusion device received CE mark, the company announced today. The next-generation minimally invasive device is designed to reduce the risk of stroke in patients with non-valvular atrial fibrillation (AFib) by helping seal the LAA of the patient’s heart. Amulet 360 features a redesigned dual-seal technology that […]
