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PolarisAR Receives Clearance from the U.S. Food and Drug Administration for Stellar Knee

Legacy MEDSearch

Food and Drug Administration (FDA). STELLAR Knee not only impacts the surgeon and the patient, but also empowers healthcare providers to change the standard of care.” Food and Drug Administration for Stellar Knee appeared first on Legacy MedSearch | Medical Device Recruiters.

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Incyte signs partnership agreement with CMS for ruxolitinib cream

Pharmaceutical Technology

Incyte will also receive royalty payments on the net product sales in the territory of CMS. In partnership with CMS, we believe that, if approved, ruxolitinib cream will be an innovative therapeutic option poised to also help patients and healthcare providers in Greater China.”.

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NeuroLogica Announces FDA 510(k) Clearance of BodyTom® 64

Legacy MEDSearch

Food and Drug Administration for commercial use in the United States. Director of Global Sales and Marketing of NeuroLogica. the healthcare subsidiary of Samsung Electronics Co., NeuroLogica Corp., NeuroLogica is the global corporate headquarters and manufacturer of mobile computed tomography devices.

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Prescribing shift for Pfizer’s Paxlovid expands access but draws questions

Pharmaceutical Technology

On 6 July, in an effort to accelerate access, the US Food and Drug Administration (FDA) allowed pharmacists to also begin prescribing the drug to eligible individuals with Covid-19. The pharmacist can then review their medical history to make sure there are no concerns of drug-drug interactions with Paxlovid.

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Welldoc Receives 10th 510(k) Clearance from FDA for Award-Winning Diabetes Platform BlueStar®

Legacy MEDSearch

Welldoc ® , a digital health leader revolutionizing chronic care, today announced the receipt of its 10th 510(k) clearance from the Food and Drug Administration (FDA) for its award-winning diabetes digital health solution, BlueStar ®. This clearance reinforces Welldoc’s position as a leader in technology in diabetes management.

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Hemosonics Awared FDA 510(k) Clearance for Quantra® Hemostasis System with QSTAT® Cartridge

Legacy MEDSearch

Food and Drug Administration (FDA) for the Quantra Hemostasis System with QStat Cartridge. Over the past 17 years, we have built one of the strongest networks of device professionals ranging from sales, marketing, research & , quality & regulatory, project management, field service, and clinical affairs.

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Ceribell Receives FDA 510(k) Clearance and CMS NTAP Reimbursement for New ClarityPro™ Software with Electrographic Status Epilepticus Diagnostic Indication

Legacy MEDSearch

Food and Drug Administration (FDA) for the indication of diagnosing Electrographic Status Epilepticus (ESE). The FDA grants a limited number of Breakthrough Designations annually, with the aim of expediting FDA review to give patients and healthcare providers accelerated access to new technologies that meet rigorous standards.

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