The FDA has granted 510(k) clearance to Orthofix Medical Inc.’s Construx Mini Ti spacer system for anterior cervical discectomy and fusion (ACDF) procedures. Company documents claim the implant has an optimized porosity and pore size, which creates a 3D porous surface with the potential for bone ingrowth.

Teleradiology company Nines Inc. won 510(k) clearance from the FDA for Ninesmeasure, an artificial intelligence (AI)-powered tool for measuring lung nodules. The Palo Alto, Calif.-based company says the new tool can help speed the diagnosis of certain respiratory diseases, resulting in better patient outcomes.

The rapidly expanding field artificial intelligence (AI)-aided image analysis received a boost with the FDA 510(k) clearance for Optellum Ltd.’s Virtual Nodule Clinic, which helps clinicians evaluate small, potentially malignant lung lesions or nodules. The action makes Optellum’s system the first cleared radiomic application for early lung cancer, an area of active research for the last five years.

Medical device startup Promaxo Inc. has received 510(k) clearance from the U.S. FDA for its office-based MRI system. The portable system is intended for use by urologists and interventional/urologic radiologists who are performing surgical localization of prostatic lesions under Promaxo MRI guidance. It can be used in the office or outpatient surgical setting without the need for significant facility upgrades.

The U.S. FDA has given a green light to Brainlab AG for two new additions to its robotic surgery systems. The agency granted 510(k) clearances for the Loop-X mobile imaging robot and the Cirq Robotic Alignment module for spine procedures, paving the way for U.S. market entry.

The U.S. FDA granted 510(k) clearance for Clew Medical Ltd.’s artificial intelligence (AI)-based solution that can predict hemodynamic instability in ICU patients eight hours in advance of deterioration. The system continuously monitors and stratifies patients by risk level to enable optimization of ICU resources.

Orthospin Ltd.'s outlook was braced by the U.S. FDA's 510(k) clearance of its next-generation digitally enabled, robotic external fixation system. The Autostrut G2 system allows preprogramming of external fixation devices used for orthopedic issues such as lengthening bones, setting complex fractures and correcting deformities.

Longeviti Neuro Solutions LLC has received the U.S. FDA’s nod for use of its Clearfit cranial implant with postoperative ultrasound imaging. The expanded 510(k) clearance could help in reducing radiation exposure linked to other post-neurosurgical imaging modalities. Research has shown that current methods of post-neurosurgical imaging put patients at risk of radiation exposure, and that an estimated 29,000 future cancers could be linked to CT scan used in the U.S. each year. Comprised of polymethyl-methacrylate (PMMA), Clearfit is a neuro-reconstructive implant that surgeons use to reconstruct a patient’s cranium following brain surgery.

Theranica Bioelectronics Ltd. has snagged an expanded clearance from the U.S. FDA for use of its smartphone-controlled Nerivio device to treat migraines in adolescents. The new indication, for acute treatment of episodic or chronic migraine in people 12 years and older, is supported by a study published last month in the journal Headache.

The portable hemodialysis market is heating up. For example, Quanta Dialysis Technologies Ltd. recently made a splash by receiving clearance from the U.S. FDA to market its portable hemodialysis system SC+. According to the Alcester, U.K.-based company, SC+ can deliver the higher dialysate flow rates typically used to provide conventional three-times-a-week prescriptions, while also offering the flexibility for more frequent, longer and gentler treatments tailored to patients’ needs.