Topic: FDA

Life Spine announced today that it received FDA 510(k) clearance for its Ghost 3D-printed titanium spacer […]

The US Food and Drug Administration (FDA) announced that it has finalized guidance on which […]

Nevro (NYSE:NVRO) announced that the FDA approved manufacturing operations in Costa Rica for the production of […]

Centinel Spine has announced the first implantation of its prodisc C Vivo cervical total disc replacement (TDR) product […]

Acurable, a UK-based medical device company, announced it raised €11 million ($10.8 million) in a […]

The Senate passed legislation on Thursday that would reauthorize the Food and Drug Administration’s user […]

Stryker has announced that its first interventional oncology technology, the OptaBlate bone tumour ablation system, […]

Medtronic recently announced the FDA approval of the Onyx Frontier drug-eluting stent (DES) and the Resolute […]

Prior to formal legislation, the use of children as subjects in medical research or drug clinical […]

Pulse Biosciences (Nasdaq:PLSE) announced today that the FDA granted 510(k) clearance for its CellFx system with […]

Iterative Scopes, a precision medicine technology company focused on gastroenterology, and Provation, a software and SaaS […]

NeuroOne (NASDAQ: NMTC) is preparing its depth electrode technology for commercialization through Zimmer Biomet (NYSE: […]

DyAnsys has received approval from the US Food and Drug Administration (FDA) for its percutaneous electrical nerve […]

Better Therapeutics (Nasdaq:BTTX) announced today that it submitted a de novo classification request to the […]

Medtronic (NYSE:MDT) announced today that the FDA approved its Onyx drug-eluting stents (DES) for treating […]

Gene therapy developer Rocket Pharmaceuticals is on track to seek FDA approval for its lead […]

Dive Brief: Medtronic has begun the full U.S. commercial release of its Evolut FX self-expanding transcatheter aortic […]

With the Transcatheter Cardiovascular Therapeutics (TCT) symposium firmly at the forefront, news relating to FDA […]

Dive Brief: Edwards Lifesciences received FDA approval on Thursday for its Pascal Precision system. The […]

Vesalio has announced US Food and Drug Administration (FDA) humanitarian device exemption (HDE) approval for […]

The US Food and Drug Administration has published new guidance recommending appropriate risk-based computer software […]

Aleva Neurotherapeutics has announced CE-mark approval of its magnetic resonance imaging (MRI) labeling for the […]

Tasso received FDA 510(k) clearance for its patch-like blood collection device, the Tasso+. The device includes […]

Potrero Medical announced today that it received FDA breakthrough device designation for its AKI Predict machine […]

Attune Medical announced today that the FDA granted investigational device exemption (IDE) to study the company’s […]

Samsung today introduced its V7 ultrasound system, having recently picked up FDA 510(k) clearance for commercial […]

Silk Road Medical has announced enrolment of the first patient in ROADSTER 3, which the […]

Otolith Labs, maker of a headband wearable that aims to treat chronic vertigo, raised $20 […]

Wenzel Spine has announced the launch of the S-LIF procedure for standalone lumbar interbody fusion […]

Dive Brief: A device that mechanically stimulates the colon to treat adults with chronic constipation […]

Abbott has announced that the US Food and Drug Administration (FDA) has approved its new […]

AxioMed has announced that it has submitted to the US Food and Drug Administration (FDA) […]

CereVasc today announced completion of the first eShunt procedure in the USA as part of […]

The FDA today removed N95 respirators from its medical device shortage list. The agency credited increased […]

Abbott has announced that the US Food and Drug Administration (FDA) has approved its new […]

Abbott Laboratories has won FDA approval for a spinal cord stimulation system positioned to treat […]

Abbott has announced that the US Food and Drug Administration (FDA) has approved its new […]

The US Food and Drug Administration has finalized rules establishing over-the-counter (OTC) availability for certain […]

The US Food and Drug Administration has granted almost 700 designations over the past seven […]