Orthopedics

Nipocalimab is an investigational FcRn blocker for treating generalized myasthenia gravis that was also recently filed for regulatory review in the US.

This week, Establishment Labs Holdings announced the FDA gave it premarket approval for Motiva breast implant, Cologuard lands FDA approval for Cologuard Plus and GE HealthCare gets FDA nod for a new imaging agent. The FDA announces another expansion for TAP into ophthalmology and radiology. The AAMI and CTA will join forces to develop standards for AI and ML-enabled health care products.  

Avidity hopes to complete enrollment in mid-2025 for an ongoing Phase III trial of its antibody-oligonucleotide conjugate in myotonic dystrophy type 1, which has no approved drug therapy.

The companies intend to co-market Siemens Healthineers’ Multitom Rax as part of Medtronic’s AiBLE ecosystem, which combines advanced technologies in navigation, robotics, imaging, data analytics, and AI to enhance the precision and predictability of spine and cranial surgeries.

This week, Neuralink announced it received US FDA breakthrough device designation for a device to restore sight; medtechs Discure and DeepLook secured new funding; FDA pump recalls from B. Braun Medical and Fresenius Kabi; Axonics prevails in patent infringement lawsuit with Medtronic; Merit Medical buys Cook Medical for $210m.

The US FDA is advising against use of the Zimmer Biomet CPT hip implant after research indicated it may pose a higher risk of thigh bone fracture than similar products.

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.

The devices include a digital therapeutic to treat ADHD and a tongue muscle stimulator to prevent sleep apnea and snoring. They all initially reached market via the de novo process and have now been declared class II.

Moximed aims to accelerate adoption of its MISHA Knee System, De Novo-approved by the US FDA in April 2023, with $91m in Series D funding. Chris Gleason, president and chief executive officer, offers perspective on the company’s innovative technology and commercial growth activities.

Caresyntax said it will use the $180m it recently raised in a series C extension and debt financing round to build out its vendor-neutral surgery platform aimed to help surgeons with real-time and long-term decision support to improve patient outcomes and efficiencies.