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Stereotaxis secures FDA approval for ablation catheter

The MAGiC catheter is designed to perform minimally invasive cardiac ablation procedures that treat various forms of ...
Becker's Hospital Review

FDA approves new class of device to treat AFib

Abbott’s Volt pulsed field ablation system — for the treatment of atrial fibrillation. The Volt system delivers high-energy electrical pulses to targeted areas of the heart to disrupt abnormal rhythms ...

Alpha Tau Submits First Pre-Market Approval Module to the FDA for Alpha DaRT® for the Treatment of Recurrent Cutaneous Squamous Cell Carcinoma (cSCC)

Initial module submission marks an important milestone in the pre-market approval process - - Flexible modular submission ...
Ophthalmology Times

FDA approvals in 2025: What changed and why it matters for ophthalmologists

FDA approvals in 2025 introduced novel therapies and devices across ophthalmic subspecialties, emphasizing sustained efficacy ...

Neuralink Plans High‑Volume Brain Implant Rollout in 2026 After FDA Clearance and $650M Funding Boost

Elon Musk’s Neuralink will begin mass production of brain implants by 2026, following FDA approval and $650M funding. The ...
AOL

FDA-approved procedure helps regrow knee cartilage, easing pain

ST. LOUIS — A newly FDA-approved procedure allows patients to regrow their own knee cartilage using autologous cell implantation. The treatment, known as MACI (Matrix Autologous Chondrocyte ...
Becker's ASC

FDA Approves MEDICREA PASS MIS System, First U.S. Procedure Performed

MEDICREA, a medical company developing surgical technologies for the treatment of spinal pathologies, received FDA approval for its PASS MIS system, according to a news release. The company also ...
Healio

FDA approves Deseyne daily disposable extended depth of focus contact lens for presbyopia

The FDA has approved Deseyne contact lenses with extended depth of focus for the correction of presbyopia, according to a ...
FiercePharma

FDA misses another approval decision target date, this time for GSK's Nucala in COPD

In the wake of mass restructuring efforts across the Department of Health and Human Services (HHS), the FDA has missed yet another approval decision target date. GSK had expected to secure an FDA nod ...
Nasdaq

Avadel Pharmaceuticals Announces Unanimous Appeals Court Decision Upholding FDA Approval of LUMRYZ in Narcolepsy in Administrative Procedure Act Litigation

DUBLIN, June 30, 2025 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, announced that, on Friday, June ...
FierceBiotech

FDA rejects Biohaven approval request for troriluzole, triggering R&D cost cutting

The FDA has rejected Biohaven’s request for approval of a neurological disorder therapy, prompting the biopharma to reprioritize its pipeline in order to shrink its annual R&D spend by 60%. After a ...