The HCPFive: Top News for Healthcare Providers from the Week of 01/11

Welcome to The HCPFive, your go-to roundup for the latest healthcare news and breakthroughs, curated specifically for busy healthcare professionals.

Each week, we highlight 5 key developments or headlines from healthcare that you need to know—whether it's a cutting-edge treatment, regulatory updates, or innovations shaping the future of medicine. This week's top stories include the US Food and Drug Administration (FDA) clearance of Medtronic’s MiniMed Go Smart Multiple Daily Injection app for use by pediatric and adult patients with type 1 diabetes or type 2 diabetes, the approvals of Neurolief’s ProlivRx brain neuromodulation therapy for adults with major depressive disorder (MDD) who did not respond to ≥ 1 antidepressant and Emergent BioSolutions’ supplemental New Drug Application (sNDA) for over-the-counter naloxone HCl Nasal Spray 4 mg (Narcan) to be packaged in a new carrying case to improve ease of transport and usability, extension of the review timeline for Travere Therapeutics’ sNDA for sparsentan (Filspari) for focal segmental glomerulosclerosis (FSGS), and request to remove information regarding the risk of suicidal ideation and behavior (SI/B) from the labeling of glucagon-like peptide-1 receptor agonist (GLP-1 RA) medications that include such language.

With The HCPFive, you'll get the essential takeaways to stay informed and ahead of the curve. Here’s your quick dive into the top stories for the week of January 11, 2025—let’s jump in!

FDA Clears MiniMed Go Smart MDI App for Adults and Children with T1D, T2D

On January 12, 2026, the FDA granted 510(k) clearance to Medtronic’s MiniMed Go Smart Multiple Daily Injection (MDI) app for use by patients with type 1 diabetes or type 2 diabetes aged ≥7 years, as well as for children between 2-6 years under adult supervision.

The MiniMed Go Smart MDI system integrates the InPen smart insulin pen with the Instinct sensor developed by Abbott, all of which are connected through the MiniMed Go app. The system provides users with missed dose alerts to minimize glucose highs, action-oriented guidance in the event of a missed or miscalculated dose, and a dose calculator to simplify dose decision-making.

FDA Approves ProlivRx, First At-Home Neuromodulation Device for MDD

On January 12, 2026, the FDA approved Neurolief’s ProlivRx, the first at-home, physician-directed brain neuromodulation therapy for adults with MDD who did not respond to ≥ 1 antidepressant. The therapy can be delivered at home under physician supervision, eliminating the access and operational challenges of clinic-based treatments.

The approval was supported by clinical evidence from the MOOD Study, a randomized, controlled, multicenter clinical trial, evaluating ProlivRx in MDD with inadequate response to antidepressant medications.

FDA Requests Removal of Suicidal Ideation and Behavior Warning From GLP-1 RA Therapies

On January 13, 2026, the FDA requested the removal of information regarding the risk of suicidal ideation and behavior (SI/B) from the labeling of glucagon-like peptide-1 receptor agonist (GLP-1 RA) medications that included such language. Affected products include liraglutide (Saxenda), semaglutide (Wegovy), and tirzepatide (Zepbound). The action follows a comprehensive FDA review that found no increased risk of SI/B associated with the use of GLP-1 RA medications.

FDA Extends Sparsentan (Filspari) sNDA Review for Focal Segmental Glomerulosclerosis

On January 13, 2026, Travere Therapeutics announced the FDA extension of the review timeline for the Company’s sNDA of sparsentan (Filspari) for FSGS. The Agency moved the Prescription Drug User Fee Act (PDUFA) target action date, which was expected on January 13, 2026, to April 13, 2026. No additional information relating to the safety or manufacturing of the drug was requested.

FDA Approves New Narcan Packaging, Aiming to Boost Carry Rates

On January 14, 2026, the FDA approved Emergent BioSolutions’ sNDA for over-the-counter (OTC) naloxone HCl Nasal Spray 4 mg (Narcan) to be packaged in a new carrying case to improve ease of transport and usability.

The new case includes 2 blister packs, each enclosed with Quick Start Guide, and is designed to be compact, discreet and durable, with the goal of making naloxone more readily carried and available. The new design aims to reduce the stigma often associated with carrying naloxone and to increase its rates of carry and chances of its use in emergencies.