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FDA Clears Implicity Heart Failure Algorithm

[ Price : $8.95]

FDA clears an Implicity 510(k) for its algorithm SignalHF used in its remote monitoring for heart failure.

Bipartisan Bill on Clinical Trial Participation

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Representatives Raul Ruiz (D-CA) and Larry Bucshon (R-IN) introduce bipartisan legislation to improve participation in clinical tr...

Brainomix Gets Clearance for AI e-Lung Tool

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FDA clears a Brainomix 510(k) for its Brainomix 360 e-Lung for lung imaging.

SCANLY Home Optical Tomography Device Authorized

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FDA grants Notal Vision a de novo authorization for its patient self-operated SCANLY Home optical coherence tomography device.

X4 Pharma Gets Priority Review Voucher

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Federal Register notice: FDA announces the issuance of a priority review voucher to X4 Pharmaceuticals in response to gaining appr...

FDA Qualifies New Ophthalmic Outcome Tool

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FDA qualifies the Assessment of IntraOcular Lens Implant Symptoms patient-reported instrument as a medical device development tool...

Lilly Once-Weekly Insulin Meets Trial Endpoints

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Lilly says its once-weekly insulin efsitora alfa met endpoints in two trials with insulin-nave adults with Type 2 diabetes.

Draeger Anesthesia Device Correction Updated

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FDA updates a Draeger Class 1 recall (device correction) of the Perseus A500 anesthesia workstation after receiving reports that t...

Biogen/Ionis Scrap ALS Drug Development

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Biogen and Ionis Pharmaceuticals discontinue the development of BIIB105 (ION541), an investigational antisense oligonucleotide for...

Drug Nanomaterial Guidance Explained

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CDER review chemist Andrei Ponta discusses the recent guidance on nanomaterials in drugs and biologics on a Center small business ...