Abbott Laboratories Inc. announced U.S. FDA clearance for its next-generation Freestyle Libre 3 continuous glucose monitor (CGM) system for people aged 4 years and older with diabetes. Accuracy of the sensor was evaluated in a non-randomized, multicenter, single-arm study with 100 people on intensive insulin therapy (95, aged 6 years and older). Results from the pivotal trial were released May 31, showing it is the first CGM to demonstrate a mean absolute relative difference (MARD) below 8%, indicating it will be one of the most accurate sensors on the market.

More than 1.6 million spinal procedures are performed in the U.S. each year and between 10% and 30% of them fail to achieve their objective, indicating that the field has abundant room for improvement. Both equipment manufacturers and the FDA hope to improve spinal surgery success rates as seen in two clearances granted on May 31.

About $1.7 trillion in securities of China-based issuers listed on U.S. exchanges could face trading prohibitions in as little as two years, Y.J. Fischer, director of the U.S. SEC’s Office of International Affairs, warned during remarks at the May 24 annual meeting of the International Council of Securities Associations.

Facing the global threat of antimicrobial resistance (AMR), the EMA issued a final revised guideline on the evaluation of new antibiotics. In accordance with an agreement with the U.S. FDA and Japan’s Pharmaceuticals and Medical Devices Agency, the EMA’s guideline aligns as much as possible with the data requirements of those regulators so drug developers can design clinical trials that meet the evidence needs of all three agencies, the EMA said.

Brazil’s health care regulator plans to start enforcing in July new regulations for software as a medical device (SaMD), clearing up doubts about its oversight over intangible health care assets such as software.

“The incomplete in vitro diagnostic regulation (IVDR) poses critical ongoing risks that need urgent resolution,” said Medtech Europe, as it welcomed the coming into force of the new EU regulatory system on May 26. Five years since the publication of the regulation, and after the industry has invested “significant resources into complying with its requirement,” some key elements of the infrastructure “are still not fully operational or even in place,” according to the trade body. “It is critical that all needed infrastructure is put in place and made operational without delay,” said Serge Bernasconi, CEO of Medtech Europe.

Lumiradx Ltd. has secured CE marking for its HbA1c test for diabetes. The point-of-care (POC), automated fingerstick assay is run on the Lumiradx portable platform and designed to provide connected results in under seven minutes, with a reportable range of 20-130 mmol/mol HbA1c (4.0% to 14.0% HbA1c).

A tissue engineered polymer wrap designed to reduce vein graft failure rates in patients on hemodialysis for chronic kidney disease (CKD) has won FDA breakthrough device designation. Developed by Houston-based Venostent Inc., the Selfwrap bioabsorbable perivascular wrap is macroporous material that wraps around blood vessels and acts as a scaffold to ensure veins and arteries work together seamlessly to filter out toxins in the patient’s blood.