Merit Medical Systems Inc. received an early holiday gift this year, reporting that its Wrapsody cell-impermeable endoprosthesis has received premarket approval from the U.S. FDA and plans to begin commercialization of the device there in 2025.

Insulet Corp.’s Omnipod 5 automated insulin delivery system has been cleared by the US FDA for the indication of type 2 diabetes, making it the first automated insulin delivery system cleared for both type 1 and type 2 diabetes management.

Abbott Laboratories reported the U.S. FDA approval of a new device specifically designed for the repair of leaky tricuspid heart valves. The Triclip was granted a PMA for the treatment of tricuspid regurgitation following the recent recommendation of the Circulatory System Devices Panel of the Medical Devices Advisory Committee for the FDA, whose vote confirmed 13 to 1, with 0 abstention that the benefits of Triclip outweighed the risks.

On March 1, Boston Scientific Corp.’s Agent drug-coated balloon (DCB) became the first DCB to gain U.S. FDA approval for treatment of in-stent restenosis in patients with coronary artery disease. With more than 100,000 patients already treated in Europe, Latin America and Japan, it’s no secret Agent provides significant benefit compared to balloon angioplasty or drug-eluting stents (DES) for the approximately 10% of patients with coronary stents who experience subsequent narrowing of the treated vessel.

Boston Scientific Corp. notched another win with the U.S. FDA approval of its spinal cord stimulator (SCS), Wavewriter, for treatment of non-surgical back pain just a week after receiving the agency’s nod for its Farapulse pulsed field ablation system. The new indication comes four months after expansion of approved uses for Wavewriter to include painful diabetic peripheral neuropathy.

The U.S. FDA accepted Novocure GmbH’s premarket approval (PMA) application to use its Tumor Treating Fields (TTFields) technology together with standard systemic therapies to treat non-small cell lung cancer (NSCLC) following progression on or after platinum-based therapy. Novocure hopes that the application, under review, will get the green light and the therapy, which uses electric fields to disrupt solid tumors and kill cancer cells, will be on the market in the second half of 2024.

In its second approval this month from the U.S. FDA, Avita Medical Inc.’s Recell system received premarket approval for the repigmentation of stable depigmented vitiligo lesions. The approval marks the first therapeutic device offering a one-time treatment for vitiligo at the point of care. Using the device, a clinician prepares and delivers autologous skin cells from pigmented skin to stable depigmented areas.

The U.S. FDA granted premarket approval to Avita Medical Inc.’s Recell system for a wide range of full-thickness skin defects, potentially quintupling the company’s market opportunity. Recell is a cell harvesting device that produces and delivers a regenerative cell suspension using a small sample of the patient’s own skin. The Spray-On Skin cells, previously approved for use in severe burns, stimulate healing and repigmentation. “This is a landmark approval representing an inflection point for Avita Medical,” said Avita CEO Jim Corbett. “The FDA approval now offers surgeons a best-in-class treatment option for a multitude of severe wounds within inpatient and outpatient settings.”

The U.S. FDA has approved Polarean Imaging plc’s drug-device combination product, Xenoview, for use with magnetic resonance imaging (MRI) in evaluating lung ventilation in adults and children aged 12 and older. The hyperpolarized contrast agent, which is prepared from the Xenon Xe 129 gas blend, is expected to be commercially available in the U.S. starting next month.

The U.S. FDA gave the greenlight to Acufocus Inc. for its IC-8 Apthera intraocular lens (IOL) for the treatment of cataracts. Like most other IOLs implanted as part of cataract surgery, the small aperture Apthera provides excellent distance vision. It distinguishes itself by also providing clear intermediate and near vision, essentially eliminating the blurring of close objects or words common as people age and develop presbyopia.