FDA Coronavirus (COVID-19) Update

The U.S. Food and Drug Administration today continued to take action in the ongoing response effort to the COVID-19 pandemic:

  • The FDA announced that the agency will host a virtual Town Hall on May 15, 2020, for researchers, clinical laboratories, and commercial manufacturers to discuss the production and use of 3D printed swabs during the COVID-19 public health emergency. This is a collaboration between the FDA, the Department of Veterans Affairs’ Innovation Ecosystem, and the National Institutes of Health’s 3D Print Exchange.
  • Today, the FDA posted a new webpage with information on use of thermal imaging systems. Thermal imaging systems and non-contact infrared thermometers use different forms of infrared technology to measure temperature. When used correctly, thermal imaging systems generally have been shown to accurately measure someone’s surface skin temperature without being physically close to the person being evaluated.
  • Testing updates:
    • During the COVID-19 pandemic, the FDA has worked with more than 390 test developers who have already submitted or said they will be submitting EUA requests to the FDA for tests that detect the virus or antibodies to the virus.
    • To date, the FDA has authorized 95 tests under EUAs, which include 82 molecular tests, 12 antibody tests, and 1 antigen test.

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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.”