Ciliatech SAS received CE certification under the Medical Device Regulation for its Intercil Uveal Spacer, a surgical implant developed to treat glaucoma. The cilio-scleral inter-positioning device lowers intraocular pressure without penetrating the anterior chamber, marking the arrival of a new treatment option for glaucoma patients.

The U.S. FDA’s draft guidance for package labeling recommendations for hernia mesh products did not draw a large volume of comments, but the Medical Device Manufacturers Association advised the agency that the information disclosed on package labels should be limited as the package is often too small to provide adequate readable information.

The U.S. FDA’s Aug. 11, 2025, warning letter to LeMaitre Vascular Inc. discloses that the agency was troubled by what it saw as problems with sterility-related processes used to manufacture the Artegraft device, findings that could complicate relations between the company and its customers.

Bio-Thera Solutions Inc. announced Aug. 26 that the European Commission cleared Usymro (BAT-2206) as a biosimilar to Janssen Pharmaceuticals Inc.’s Stelara (ustekinumab). The EMA issued marketing authorization for Usymro on Aug. 14, following the EMA’s Committee for Medicinal Products for Human Use adopting a positive opinion on June 19.

The 50 million Europeans with peripheral artery disease have a new treatment option thanks to help restore blood flow to vessels below the knee now that Abbott Laboratories' Esprit BTK everolimus-eluting resorbable scaffold system has received CE mark. The stent, made of a material similar to dissolvable sutures, dissolves within three years.

The U.S. Patent and Trademark Office has reacted to the Federal Circuit’s decision in Shockwave v. CLSI with a policy memo that draws tighter lines around the use of applicant admitted prior art in attempts to invalidate a patent during inter partes reviews.

The Medical Device Authority of Malaysia reported on Aug. 22 the piloting of a bilateral medical device approval program with Singapore to streamline the review and launch of medical devices in both countries.

South Korea’s Ministry of Food and Drug Safety (MFDS) launched a new industry-academia-research consortium to support the nation’s organoid industry, expected to grow in light of the U.S. FDA’s shift away from animal testing in the development of novel drugs.

A few years after it was founded with the aim of taking RNA therapies to the next level, Arnatar Therapeutics Inc. emerged from stealth, disclosing a $52 million series A round raised in 2024 as well as U.S. FDA orphan and rare pediatric disease designations for ART-4, an antisense oligonucleotide candidate targeting the root cause of Alagille syndrome.