Spaulding Clinical Research Awarded Five-Year Contract With FDA Division of Applied Regulatory Science

The company reports the objectives of each trial vary considerably among different therapeutic areas, but all address important regulatory science questions in today’s pharmaceutical market.

“We are happy to partner with the FDA to help address agency questions about various classes of drugs. Spaulding Clinical is perfectly suited to conduct these trials as we have the right-sized project management and principal investigator team that will be able to give the FDA office the attention they need,” said Cassandra Erato, CEO at Spaulding Clinical Research.

Spaulding Clinical has been working with the U.S. government on clinical trials over the past seven years. “We began conducting clinical trials for the FDA to explore a model to screen new drugs for prolongation of QT. Through this work and resulting publications, we have developed a productive partnership,” said Dr. Jay Mason, chief medical officer at Spaulding Clinical Research.

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Cartessa Aesthetics Partners with Classys to Bring EVERESSE to the U.S. Market

Classys, which is listed on the KOSDAQ, is one of South Korea's most distinguished aesthetic technology manufacturers, with devices distributed in 80+ markets globally. This partnership marks Classys's official entry into the American marketplace, with Cartessa Aesthetics as the exclusive distributor for EVERESSE, launched under the Volnewmer brand in current global markets.

Stryker Launches Next-Generation of SurgiCount+

Now integrated with Stryker's Triton technology, SurgiCount+ addresses two key challenges: retained surgical sponges and blood loss assessment. Integrating these previously separate digital solutions provides the added benefit of a more efficient, streamlined workflow for hospitals notes Stryker.

Nevro Receives CE Mark In Europe for It’s HFX iQ™ Spinal Cord Stimulation System

Nevro notes HFX iQ is the first and only SCS system with artificial intelligence (AI) technology that combines high-frequency (10 kHz) therapy built on landmark evidence that uses ongoing cloud data insights to deliver personalized pain relief

Recor Medical Reports: CMS Grants Distinct TPT Device Code and Category to Recor Medical for Ultrasound Renal Denervation

The approval of TPT offers incremental reimbursement payments for outpatient procedures performed with ultrasound renal denervation for Medicare fee-for-service beneficiaries. It becomes effective January 1, 2025, and is expected to remain effective for up to three years notes Recor Medical.

Jupiter Endovascular Reports | 1st U.S. Patient Treated with Jupiter Shape-shifting Thrombectomy Device

“Navigation challenges during endovascular procedures are often underappreciated and have led to under-adoption of life-saving procedures, such as pulmonary embolectomy. We have purpose-built our Endoportal Control technology to solve these issues and make important endovascular procedures accessible to more clinicians and their patients who can benefit from them,” said Carl J. St. Bernard, Jupiter Endovascular CEO. “This first case in the U.S. could not have gone better, and appears to validate the safety and performance we are seeing in our currently-enrolling European SPIRARE I study.”