Help Define the Future of AI in Healthcare Presented by MedCity News

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Featured Story   Aurenar's Ear-Based Device Earns FDA Breakthrough Device Designation FDA spotlight This week, the FDA granted breakthrough device designation to Aurenar's V-Link system, a non-invasive nerve stimulation device designed to treat cerebral vasospasm. Vasospasm is one of the most dangerous complications that can occur after a brain hemorrhage. It happens when blood vessels in the brain narrow in the days following an aneurysm, cutting off blood flow to brain tissue and risking further, typically severe, damage on top of the initial bleed. Providers have historically lacked the tools to prevent vasospasm. The main option is an oral drug, backed up by invasive rescue procedures like balloon angioplasty. How it works Instead of waiting to intervene after vessels have already constricted, Aurenar's earbud-style device delivers gentle electrical pulses to a nerve behind the ear to calm the body's inflammatory response, which is the same response believed to drive the spasming in the first place. Patients receive the treatment for 20 minutes twice a day during their ICU stay, explained Aurenar CEO Eric Leuthardt. The device is designed to fit into existing ICU workflows so that nurses and physicians can use it without much training, he added. Early results In a trial, the V-Link’s approach cut moderate-to-severe vasospasm by more than 40% with no safety issues reported. The trial had only 27 patients, but Leuthardt is confident that the V-Link’s vasospasm reduction rate will hold up at scale. “The 27-patient trial was a randomized, triple-blinded study — meaning patients, clinicians and outcome assessors were all blinded — which is the strongest study design for a trial of this size. The effect size we saw was substantial and reached statistical significance, and the result was consistent with what we’d expect biologically given how vagus nerve stimulation modulates inflammation,” he stated. Still, Aurenar is approaching its evidence generation with “the appropriate humility,” Leuthardt remarked. The breakthrough device designation is meant to speed up the path toward larger pivotal trials, which he noted are designed precisely to confirm whether the product’s benefits hold up at scale. — By Katie Adams Sponsored   Help Define the Future of AI in Healthcare Presented by MedCity News We want to know: how prepared is your organization? Take 3 minutes to share your perspective and help guide the future of AI infrastructure in healthcare. Your insights will directly shape an upcoming industry report, and as a thank you, we will send you a $20* Gift Card. *In order to receive a gift card, participants must complete the survey, meet survey qualifications (we are looking for individuals who work for payers or providers with health plans and whose position is director level or higher), and provide a valid business email address. Top Stories   Roche Asserts Its Place in a Competitive Class of Cancer Drugs The news Roche reported its non-small cell lung cancer drug, divarasib, met the goals of a Phase 3 clinical trial that tested the small molecule head to head against approved drugs in the same class from Amgen and Bristol Myers Squibb. Without reporting specific figures, Roche said its drug achieved better measures of survival, adding that more detailed data would be presented at a future medical conference. The company also said it plans to submit the data to regulators as it seeks approval of the cancer drug. The drug Divarasib is an oral small molecule inhibitor of KRAS G12C, a protein that, when mutated, drives cancer growth. Amgen’s Lumakras won the first FDA approval in this drug class, followed by Krazati, which is marketed by Bristol Myers Squibb. Roche said its drug is designed to offer greater potency and selectivity to the target protein. Why this matters Scientists have long known that mutated KRAS drives cancer, but these proteins have eluded many efforts to drug them. The tide turned in 2021 as FDA approval of Amgen’s Lumakras blazed a trail for other companies to follow in pursuit of these proteins. Like Lumakras and Krazati, Roche’s divarasib blocks activated KRAS G12C to prevent it from leading to the signaling that drives cancer. But there are other companies developing drugs that work this way, as well as others developing drugs that block the protein in both the active and inactive state in order to prevent KRAS G12C from becoming active. Soundbite “The superior survival demonstrated in this global head-to-head comparison of KRAS G12C inhibitors confirms the potential of divarasib to improve clinical outcomes for people with KRAS G12C non-small cell lung cancer,” Roche Chief Medical Officer and Head of Global Product Development Levi Garraway said. “These results should establish divarasib as a new standard of care for previously-treated lung cancer patients with this genetically defined tumor subtype.” —By Frank Vinluan Color Broadens Cancer Expert Medical Opinion Program The news Color, a virtual cancer clinic, announced Tuesday that it has expanded its Expert Medical Opinion services to include a new peer-to-peer program. The expansion San Francisco-based Color serves employers, health plans, unions and the public sector. It helps identify high-risk members, screens patients, provides clinical care for those in treatment and supports cancer survivors. Color's Expert Medical Opinion program provides multidisciplinary reviews at every clinical decision point for enrolled patients through the company's 50-state medical group. The company has expanded the program with a new peer-to-peer service that connects patients and their oncologists with specialists at Color. Prior to the expansion, multidisciplinary reviews were only provided to those currently enrolled in Color’s program. But the peer-to-peer program allows Color to proactively identify and review complex cancer cases within health plan and employer populations using claims and prior authorization data, even if those patients are not currently enrolled in Color’s program. Color will then work with the patient’s local provider and discuss recommendations with the provider, as well as work with the patient for supportive care and clinical guidance. To support this expansion, Color has also brought on additional specialists and sub-specialists from National Cancer Institute-designated cancer centers, including for breast cancer, gastrointestinal cancers, gynecologic oncology, cancer genetics, cardio-oncology and palliative care. These specialists offer multidisciplinary diagnosis reviews, tumor boards and ongoing treatment evaluations. Soundbite “While a traditional second opinion is one consultation with one expert at one point in time, cancer is always evolving,” said Caroline Savello, president of Color Health. “Diagnoses progress, treatments change, toxicities emerge, and clinical trials open and close. What patients actually need is ongoing, multidisciplinary review from a team that knows their case and has the authority to act on what it finds. That has historically only been available to a small fraction of patients with the rarest and most complex cases, largely because convening a panel of subspecialists requires high cost, coordination, and proximity to a major academic center.” — By Marissa Plescia Healthcare Retention Depends On Better Pathways, Not Just Better Pay The issue Getting employees to stay in today’s landscape is no easy task. It requires ensuring employees aren’t just happy in their role, but have a clear path to their next one if they aspire to level up. Career stagnation can be an easy problem to miss, especially when headcount looks stable or vacancy pressure eases. But when workers feel stuck in place, with limited opportunities to advance or deepen their skills, disengagement tends to follow. In allied health roles, where burnout is already high and many touch the patient experience, it is a risk healthcare employers cannot afford to ignore. The barriers Medical assistants and other allied health professionals are essential to care delivery, particularly in outpatient settings where they often shape a patient’s first impression of a health system. They keep care moving, support clinicians, and create continuity for patients. Yet too often, these professionals encounter a workplace reality defined by narrow advancement options and unclear next steps. Common barriers include: Entry-level wages that don’t support further academic pursuits Limited employer reimbursement for advanced training A lack of professional development opportunities Unclear or nonexistent career pathways A competitive necessity Career pathways are gaining traction as a proven retention strategy as 91% of employers believe career laddering programs improve retention and 64% are currently offering internal training and advancement programs. Investment in career pathways and manager-led development is becoming a competitive necessity. In a market where mobility is lower, the employers that stand out will be the ones that create forward motion internally. They will be the organizations that treat retention not as a defensive tactic, but as a long-term talent strategy. — By MedCity Influencer Angie Holub   Video   Video: How Providers Help Patients Navigate Insurance Confusion Providers are spending a lot of time and resources hunting down reimbursement and helping patients navigate their coverage. Here’s more from Katie Adams at HFMA’s annual conference, where she spoke with James Lee, CFO of Multicare.

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Podcast   MedCity Pivot Podcast: The Evolution of Palliative Care at Home In this month's pivot podcast, I speak to the chief medical officer of San Francisco-based Vynca, an innovative company in the world of palliative care that is providing serious disease management at home. View Now

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