Saturday, 5 September 2026
RN prescribing software gaps, Injectable iron safety review, Spinal stimulator lead recall
- 01
Unresolved software requirements cloud October rollout of RN prescribing
PBS-subsidised prescribing by registered nurses faces unresolved technical and workflow questions ahead of its planned 1 October start, according to the Medical Software Industry Association. RNs with additional training will be authorised to prescribe certain Schedule 4 and Schedule 8 medicines under an active prescribing agreement with an authorised health practitioner. Vendors are seeking details on how to identify eligible prescribers, enforce medicine restrictions and integrate prescribing with electronic prescribing systems and My Health Record. More than 70 questions arose during an industry meeting with government agencies and the nursing union on 25 August, with the association saying software development, testing and possible conformance testing cannot be scheduled until specifications are clear.
- 02
EMA reviews injectable iron over hypophosphataemia and bone harms
The European Medicines Agency has begun reviewing all injectable iron-containing medicines over the risk of hypophosphataemia and related bone disorders, including osteomalacia and fractures. The review followed serious reports involving ferric carboxymaltose, including cases after only one or two doses in people without recognised risk factors, as well as delays in diagnosis. Hypophosphataemia is a known common adverse effect of ferric carboxymaltose, affecting up to 1 in 10 recipients, while the frequency of hypophosphataemic osteomalacia is unknown. Similar cases reported with other injectable iron products prompted the Pharmacovigilance Risk Assessment Committee to broaden the review, while oral iron is excluded. The committee will assess the risks, the effectiveness of existing risk-reduction measures and whether changes to marketing authorisations are required.
- 03
Boston Scientific recalls Infinion CX leads after 1,081 injuries
Boston Scientific has recalled unused Infinion CX spinal cord stimulator leads because mechanical stress at the anchor site may cause high impedance or lead fracture. The FDA classified the action as a Class I recall, affecting 1,079 devices, after the company reported 1,081 associated serious injuries as of 27 May. The problem may cause inadequate or lost stimulation and, if reprogramming does not resolve it, require removal or replacement of the lead. The recall does not affect already implanted devices, and the FDA recommended no additional monitoring beyond routine clinical follow-up. Boston Scientific instructed customers to stop using and distributing the unused leads and return them to the company.
via MedTech Dive
- 04
Vara gains European approval for autonomous normal mammogram reporting
Vara received Europe’s first authorisation for an AI-enabled system that can report mammograms it classifies as normal without radiologist review. All other results must be read by at least one radiologist, compared with Europe’s standard practice of two radiologists interpreting each screening mammogram. The Class IIb device met the EU AI Act’s continuous human oversight requirement using a safety system that monitors hardware, system health and daily performance, and can revert sites to full radiologist reading when values exceed set limits. The autonomous triage feature is now available to screening programs across Europe, with rollout dependent on individual countries’ guidelines and readiness. A company-funded study of more than 460,000 women previously found a higher breast cancer detection rate with AI-supported double reading than with standard double reading.
via MedTech Dive
- 05
FDA approves first medicine for Alexander disease
The US Food and Drug Administration has approved Zanvastro as the first medicine for Alexander disease, an extremely rare, often fatal progressive neurological condition. Developed by Ionis Pharmaceuticals, the drug reduces production of a protein that forms toxic clumps, progressively damaging the nervous system and causing motor and cognitive dysfunction. The FDA based its decision on a study in which patients treated with Zanvastro were significantly more stable during a walking test. Ionis said the medicine would become available in the US in the coming weeks, marking the company’s first independent product launch from its neurology pipeline.
via BioPharma Dive
- 06
AMA urges sustained private health funding and regulatory reform
Private health insurer rebates and MBS funding must rise significantly to sustain private hospitals, maternity units and psychiatric care, the AMA says. In its response to the first of three federal consultation papers, the association said funding had not kept pace with costs, hundreds of thousands of Australians had downgraded their private insurance, and more than 14 private maternity units had closed over five years. It opposed a proposed exemption from in-person follow-up requirements for some overseas-trained psychiatrists, arguing it could affect patient safety and draw specialists away from underserved regional and remote areas. The AMA supported proposed hospital-in-the-home reforms and several Type C certification exemptions, while also seeking simpler insurance products, greater rebate transparency and a fit-for-purpose regulator. It called for reforms to begin as soon as annual processes allow and remain in place for at least five years.
MDDR is a news digest for medical professionals. It is not medical advice and should not be relied on for clinical decision-making.