LEXINGTON, S.C., July 15, 2026 /PRNewswire/ — ElectroWire Medical announced today that the U.S. Food and Drug Administration has granted 510(k) clearance for its LightningWireTM Transseptal Puncture System, which is indicated to create an atrial septal defect in the heart, whereby various cardiovascular catheters are introduced.
TORONTO, July 15, 2026 /PRNewswire/ — SpinaFX Medical Inc. (“SpinaFX”), a Toronto‑based medical device company specializing in image‑guided, minimally invasive spine care, today announced it has received Medical Device Regulation (MDR) CE Mark certification for its Triojection® System (MDR 843778).
Automated software helps respiratory therapists identify ineffective efforts, the most frequent type of patient-ventilator asynchrony in mechanically ventilated patients
B. Braun Medical Inc. announced the FDA approval of Sugammadex Injection, 200 mg/2 mL (100 mg/mL), AP-rated generic BRIDION®1* (Sugammadex Injection) in the U.S. market.
Newronika announced today that it secured CE mark for its latest adaptive deep brain stimulation (aDBS) system.
SUNNYVALE, Calif., July 13, 2026 /PRNewswire/ — Embolx, Inc., a leader in advanced microcatheter technology for targeted embolization procedures, today announced that the Centers for Medicare & Medicaid Services (CMS) has established a new HCPCS Level II code, G0577, covering Sniper® procedures performed in the physician office, or office-based lab (OBL), setting. The new code took effect July 1, 2026.
STOCKHOLM, July 13, 2026 /PRNewswire/ — BioArctic AB’s (publ) (Nasdaq Stockholm: BIOA B) partner Eisai today announced that the US Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for a once weekly lecanemab irmb subcutaneous injection (US brand name: Leqembi Iqlik®) as a starting dose for the treatment of early Alzheimer’s disease. The US launch is planned for late August 2026.
HistoSonics announced today that it received CE mark approval for its Edison non-invasive histotripsy technology platform.
Claria Medical announced today that it received FDA de novo authorization for its Claria system for minimally invasive hysterectomies.
Abbott (NYSE:ABT) announced today that the FDA approved the longer length (76 mm) Esprit BTK drug-eluting scaffold system.