Topic: FDA

DiscGenics has announced that the US Food and Drug Administration (FDA) has granted Regenerative Medicine […]

Boston Scientific (NYSE:BSX) announced today that it received FDA 510(k) clearance for its LithoVue Elite single-use […]

Vero Biotech announced that the FDA approved its second-generation Genosyl system for use with rebreathing […]

One challenge of developing a drug for a disease with no approved therapies is that […]

Axonics has announced that the US Food and Drug Administration has approved the company’s fourth-generation […]

Abbott (NYSE:ABT) announced today that the FDA approved its spinal cord stimulation system for treating painful […]

The CELLO II balloon guide catheter (Fuji Systems Corporation) has received 510(k) premarket approval from […]

Aetion, a startup focusing on real-world evidence in healthcare, announced a five-year research collaboration with […]

CardioRenal Systems announced today that it received FDA breakthrough device designation for its RenalGuard Therapy […]

Abbott (NYSE:ABT) announced today that it received FDA approval for its latest-generation transcatheter aortic valve implantation […]

VySpine announced today that it received FDA 510(k) clearance for its LumiVy NanoVy TI lumbar intervertebral […]

Vero Biotech announced that it received FDA approval for its latest-generation tankless inhaled nitric oxide […]

Empirical Spine has revealed that it has recently completed the final step in the US […]

Movano Health (Nasdaq:MOVE) announced today that it unveiled its Evie smart ring designed specifically for […]

Congress passed the FDA Modernization Act 2.0 last week removing the requirement to use animal […]

Dozee scores 510(k) for AI contactless sensor for RPM Indian medical device company Dozee has […]

Providence Medical Technology has announced that the US Food and Drug Administration (FDA) has cleared […]

Insightec announced today that it received additional FDA approval for treating essential tremor with its Exablate […]

Abbott has obtained FDA clearance of its Eterna spinal cord stimulation (SCS) system for the treatment […]

Back in 2013, Oxford Performance Materials made Medtech history by scoring the first FDA clearance […]

Saluda Medical has announced plans for a limited commercial release of its Evoke spinal cord […]

Bladder cancer can be treated with several types of drugs. Gene therapy is now part […]

Dive Brief: Click Therapeutics has received breakthrough device status for its prescription digital migraine therapy. The Food […]

Life Spine has announced that it has received 510(k) clearance from the US Food and […]

Dive Brief: Dexcom received clearance from the Food and Drug Administration for its G7 continuous […]

Avenda Health received FDA 510(k) clearance for AI-backed clinical decision support software that assists physicians […]

Israeli company ChroniSense Medical received FDA 510(k) clearance for its Polso wearable that collects and […]

Imagen Technologies announced today that the FDA cleared its computer-assisted detection (CADe) device, Aorta-CAD. New York-based […]

Wise announced today that it received FDA clearance for its Wise Cortical Strip (WCS) for […]

The Swiss Federal Assembly has voted in favour of accepting medical devices with US Food […]

NeuroLogica — a Samsung Electronics subsidiary — announced today that it received FDA 510(k) clearance for its […]

Avicenna.AI has today announced a distribution agreement with CARPL.ai—a company providing a technology platform that […]

Dive Brief: Zimmer Biomet received 510(k) clearance for its Persona OsseoTi Keel Tibia for cementless knee replacement. […]

Israeli startup AEYE Health announced last week it had received FDA 510(k) clearance for its […]

Dive Brief: H2o Therapeutics has received 510(k) clearance for an Apple Watch app that monitors Parkinson’s disease […]

LivaNova (Nasdaq: LIVN) says a new FDA clearance expands how long health providers can use […]

Centinel Spine has announced the first implantation of its prodisc C SK cervical total disc replacement […]

Accelus has announced that it has received US Food and Drug Administration (FDA) 510(k) clearance […]

Nevro Corporation has announced that it has received approval from the US Food and Drug Administration (FDA) […]