New Mexican president Andrés Manuel López Obrador, a member of the National Regeneration Movement (MORENA) party, has swept the office on an anticorruption platform. Some observers expect his efforts to include reforms and increased regulation touching the medical device sector. Nicholas Berg, an attorney with Ropes & Gray, said that in the past Mexico has made limited efforts to combat public corruption. See his advice for medtech companies planning on doing business in Mexico here.
“In particular, medtech companies should be cautious and implement stringent oversight over third-party consultants, intermediaries, agents, distributors, and others that negotiate or interact with Mexican government officials or representatives of state-owned entities, as these types of relationships have proved fertile ground for FCPA cases in recent years, as have interactions with customs officials." —Nicholas Berg, attorney, Ropes & Gray
Click here for a free trial of Medtech Insight
El Salvador has approved a new law that will establish a new regulatory body responsible for authorizing medicines and setting prices.
This week, Quidel recalled the Triage cardiac panel due to a risk of false results; Teladoc and Lifebit announced new partnerships; and, a court upheld a false advertising verdict against Natera, but struck the financial penalties.
This week, North Carolina health secretary Mandy Cohen was named the new head of the CDC; Congress debated PAHPA reauthorization; Cala Health launched a Parkinson’s Disease wearable; and IHealth.io was fined for consumer privacy violations.
The US FDA says it’s “investigating certain imported medical gloves that appear to have been reprocessed, cleaned, or recycled and sold as new.” The 270 firms in question are listed on an import alert that says their gloves are subject to Detention without Physical Examination.
The US FDA has published a trio of draft guidance documents for its Assessment Scheme for Conformity Program, which began as a pilot in September 2020 to capitalize on the role of standards in the regulation of medical devices.
UK-based Biocomposites will begin selling in the UK its next-generation osteoinductive bone graft substitute, NanoBone, which came with its acquisition of Artoss GmbH in June 2023. Meanwhile, the company has purchased remaining shares in the manufacturers of SYNICEM and Subiton antibiotic bone cements and preformed antibiotic-loaded spacers.
US FDA has greenlighted Senseonics’ Eversense 365 continuous glucose monitor, which must be replaced just once a year. Capable of being integrated with compatible insulin pumps as part of an automated insulin delivery system, the fully implantable device lasts 185 days longer than the Eversense E3 sensor and far outstrips competing CGMs, which last only for 10-14 days.
