Healthcare & Health Industry Wire — Week of September 29, 2026: Five new drugs, a $340 million clinical AI round, and 315,000 canceled enrollments
This week's U.S. healthcare scan covers a $340 million clinical-AI financing, five novel drugs the FDA approved in six days led by a first-in-class Parkinson's treatment, Medicare's projected 2027 premium decline, 315,000 canceled Marketplace enrollments and a freeze on new broker registrations, and a 36-center urgent care acquisition.
Coverage window: September 22–29, 2026
This edition covers U.S. healthcare developments published or completed during September 22–29, 2026. The largest private financing of the week went to a clinical artificial intelligence company. The U.S. Food and Drug Administration (FDA) cleared five new drugs in six days. Medicare projected lower premiums for 2027 while its parent agency canceled hundreds of thousands of Marketplace enrollments. And the biggest hospital transaction of the week was 36 urgent care clinics.
1. Health-tech funding and products
Heidi raises $340 million as clinical AI moves past note-taking
Status: Heidi announced the financing on September 22; the company said the round is closed.
Heidi closed a $100 million Series C round led by Blackbird, with Phoenix Court, Point72 Private Investments and Headline participating, at a $900 million valuation. General Catalyst's Customer Value Fund separately led a $240 million growth investment, bringing total new funding to $340 million. 1
Heidi sells an AI "care partner" that records and drafts clinical notes during visits, and it now wants to handle work around the visit as well: retrieving guidelines at the point of care, drafting the actions a clinician approves, and running on its own wearable. The company put its traction at more than 175 million patient visits supported, up from 73 million at its previous round, across 190 countries, with annual recurring revenue growing from $1 million to $50 million by April 2026. Those figures are the company's own. 1
The buyer to watch here is a health system, not a consumer. Heidi said its enterprise activation rate is about 62% and named Beth Israel Lahey Health in Massachusetts among its customers, alongside a selection as sole supplier for National Health Service England Midlands. A system weighing a competing vendor should ask the same two questions of each: how often the tool is actually used once it is installed, and who carries liability when it drafts a wrong instruction. The financing is largely a bet on the second answer. 1
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OpenEvidence reaches a $15 billion valuation on a $250 million round
Status: The company confirmed the round to trade press on September 28.
OpenEvidence raised $250 million led by Andreessen Horowitz and Byers Capital, valuing the clinical decision-support platform at $15 billion. Founder and chief executive Daniel Nadler confirmed the raise and the lead investors in a September 28 email. The new valuation follows a $12 billion mark the company reached in January after a $250 million Series D. 2
OpenEvidence answers physician questions with citations drawn from peer-reviewed studies and clinical guidelines, including the New England Journal of Medicine and the Journal of the American Medical Association. The company says more than half of U.S. physicians use the platform regularly, and it is embedded in the Epic electronic health record at health systems including Mount Sinai Health System and Sutter Health. Founded in 2022, it has raised close to $1 billion in total. 2
For an adopting system, the number that matters is the adoption claim rather than the valuation. A fivefold valuation increase in eight months prices in continued growth, and a share of physicians measured as "more than half" is broad enough that it says little about how deeply any one clinician relies on the tool.
Rightway raises $155 million to sell employers on pharmacy accountability
Status: Rightway announced the Series E on September 24.
Rightway raised $155 million in Series E financing led by Francisco Partners, with Thrive Capital and Khosla Ventures participating. The New York company runs pharmacy benefit management and care navigation for employers and counts 45 Fortune 500 companies as clients. 3
Prescription drug spending among large U.S. employers rose 9.4% in 2025, faster than the 6% increase in overall health benefit costs, according to the Mercer survey Rightway cited. Rightway's pitch is a contractual one: it sets a maximum on total pharmacy spend, excludes categories that competing guarantees often leave out — including glucagon-like peptide-1 (GLP-1) weight-loss drugs and rare-disease medications — and passes through 100% of manufacturer rebates. Employers comparing managers should ask how much of a guarantee survives when a member starts an expensive drug, because that is the scenario the guarantee exists for. 3
2. Pharma and device FDA news
The FDA clears a first-in-class Parkinson's drug
Status: The FDA approved Juvmo on September 25; AbbVie announced the approval on September 28 and expects the drug in U.S. pharmacies in October 2026.
The FDA approved Juvmo (tavapadon) tablets for adults with Parkinson's disease. It is the first and only selective D1/D5 receptor agonist approved for the condition, a different target from the D2/D3 dopamine agonists that have been the standard add-on therapy for decades. A dopamine agonist mimics dopamine at receptors in the brain; the D1/D5 family is the one most associated with movement control. 45
AbbVie's Phase 3 TEMPO program tested the drug in three settings. In TEMPO-3, for patients already taking oral levodopa who were experiencing motor fluctuations, adding tavapadon increased daily "on" time without troublesome involuntary movements by 1.7 hours, against 0.6 hours for placebo, and reduced daily "off" time by 1.9 hours, against 0.9 hours. In the open-label extension, 93% of patients taking tavapadon with levodopa for 85 weeks had not increased their levodopa dose, and 94% of those taking tavapadon alone had not started levodopa. The company reports those results; the trial data have not been through independent replication. 5
The label warns about low blood pressure that can cause dizziness on standing, unusual urges such as compulsive gambling or shopping, hallucinations, and dyskinesia, the involuntary movements that can worsen with treatment. The most common side effects are nausea, headache, a change in taste, fatigue, vomiting, dry mouth and anxiety. In TEMPO-3 the drug was given alongside oral levodopa, the therapy most patients with the condition already take. 5
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Four more novel drugs in the same week
The FDA's novel-drug list counts five 2026 approvals dated inside this window. Juvmo is one; these are the other four, each with what it treats and the number that sizes it. 4
- Emcitate (tiratricol), approved September 28 — the first treatment for MCT8 deficiency. The disease, also called Allan-Herndon-Dudley syndrome, leaves the brain short of thyroid hormone while the bloodstream carries too much, and it mostly affects boys. The once-daily oral suspension can be swallowed or given through a feeding tube. Tiratricol enters cells without the transporter that the disease has broken, which is what lowers the excess hormone in the blood. The evidence comes from an international randomized placebo-controlled trial plus a longer open-label study in patients ranging from infants to adults; the most common side effects were diarrhea, vomiting, rash and excessive sweating, and the drug should not be combined with another thyroid medication. Approval went to Egetis Therapeutics US Inc. 6
- Atebrioz (zilurgisertib), approved September 25 — the third treatment for fibrodysplasia ossificans progressiva. In this rare genetic disease, muscle, tendons and ligaments turn into bone. In a 63-patient randomized trial, the group taking Atebrioz had an average 3.2 cubic centimeter decrease in new bone volume outside the skeleton at 24 weeks, while the placebo group had a 24.6 cubic centimeter increase. The recommended starting dose is 100 milligrams once daily, and the drug can cause fetal harm, so patients of reproductive potential need effective contraception. 7
- Lyrfigtu (lirafugratinib), approved September 23 — bile duct cancer with an FGFR2 fusion. The drug treats adults with previously treated, unresectable or metastatic cholangiocarcinoma whose tumors carry a fibroblast growth factor receptor 2 gene fusion or rearrangement. In the 116-patient REFOCUS trial, 46% of patients responded and the median response lasted 11.8 months. Warnings cover eye toxicity, high phosphate levels with soft-tissue mineralization, and fetal harm. Approval went to Elevar Therapeutics. 8
- Onswik (insulin efsitora alfa-gobe), approved September 23 — an insulin for type 2 diabetes. The FDA lists it for improving blood sugar control in adults with type 2 diabetes alongside diet and exercise. 4
Two approvals in the window expanded drugs that were already on the market. On September 24 the FDA approved belzutifan (Welireg, Merck) with lenvatinib (Lenvima, Eisai) for advanced kidney cancer with a clear cell component after a PD-1 or PD-L1 inhibitor. In the 747-patient LITESPARK-011 trial, median progression-free survival was 14.6 months on the combination against 10.6 months on cabozantinib, and the overall survival difference was not statistically significant. Belzutifan carries a boxed warning for embryo-fetal toxicity. 9 On September 25 the FDA approved Gazyva (obinutuzumab) to reduce relapse risk in children and adults aged 2 and older with frequently relapsing or steroid-dependent childhood-onset idiopathic nephrotic syndrome who are in remission. The FDA says a significantly greater share of patients receiving Gazyva met the trial's protein-in-urine endpoint at 52 weeks than those on mycophenolate mofetil, the standard-of-care comparator in the 85-patient INSHORE study. Gazyva's label carries a boxed warning for hepatitis B reactivation and a rare brain infection. 10
The FDA drafts new submission rules for surgical robots
Status: The draft guidance was published September 25, after the FDA posted it September 24; comments close November 24, 2026.
The FDA published draft guidance on premarket submissions for robotically assisted surgical devices, which it describes as teleoperated, software-controlled systems that help a practitioner position and control instruments during open, minimally invasive or endoluminal procedures. The draft sets out what manufacturers should submit for nonclinical and clinical testing. It is not final and not binding, and it carries docket number FDA-2026-N-9505. 11
The same week, the FDA scheduled a public workshop on evaluating benefit and risk in robotic devices that act autonomously or under remote teleoperation — the two capabilities that sit closest to the edge of the current review framework. 12
A Boston Scientific catheter is recalled as Class I
Status: The FDA classified the recall as Class I, its most serious category, on September 25.
Boston Scientific told customers to stop using Imager II Angiographic Catheters, which carry contrast dye into peripheral blood vessels during imaging procedures. The company found the catheters were made with reduced levels of stabilizing agents in the tip, which can let the tip degrade and detach. It has also decided to discontinue selling the product. The most common consequence of a detached tip is a delay while the device is exchanged; the most serious, described as remote, is a fragment travelling downstream and blocking blood flow to an organ. Boston Scientific reported two serious injuries and no deaths as of July 16. 13
Facilities should quarantine affected stock and return it, checking both inner and outer package codes, because the two labels carry different numbers. 13
No new device authorization or clearance decision dated inside this window appeared on the FDA's own device pages, so this edition's device news is the guidance and the recall.
3. Insurance and policy
CMS cancels 315,000 Marketplace enrollments and freezes new broker registrations
Status: CMS announced the actions September 22; the interim final rule took effect that day and was published September 23.
CMS said it is canceling approximately 315,000 unauthorized enrollments covering more than 760,000 people, which it expects to return roughly $2.2 billion in taxpayer-funded subsidies. The agency also imposed a temporary moratorium on new registration for the 2027 plan year for agents and brokers that do not hold an active Exchange agreement for 2026, in effect until February 1, 2027. 14
The authority for the freeze comes from an interim final rule, a regulation that takes effect on publication before comments are collected. It codifies the Department of Health and Human Services' power to pause registrations in the federally facilitated Exchanges, took effect September 22, and appears at 91 FR 60317 under docket CMS-9872-IFC. The moratorium reaches the federally run Exchanges and the state-based Exchanges that use the federal platform; it leaves the fully state-run Exchanges untouched. 15
CMS is also adding four safeguards: existing agents and brokers must re-verify their identity through Login.gov or ID.me; applications that involve an agent or broker must include a Social Security number or immigration document number CMS can check; the system will block agents and brokers from attaching themselves to applications consumers should complete themselves; and a consumer must authorize an agent electronically before that agent can act on an application. Since January 2026, CMS has issued termination notices to more than 200 non-compliant agents and brokers and notices of intent to terminate to 569 more. 1416
Scale puts those numbers in context: about 23.1 million people enrolled in Exchange coverage for 2026, according to CMS's March count. The cancellations are therefore a small share of total enrollment. The moratorium targets agents and brokers who first registered for 2026, a group CMS says accounts for a small share of assisted enrollments and a much larger share of unauthorized ones. Whether the safeguards hold will show up in the enrollment figures CMS publishes after the 2027 sign-up period closes. 17
Medicare Advantage premiums are projected to fall for 2027
Status: CMS released the 2027 figures September 28, ahead of open enrollment; the numbers are projections based on plan bids.
The weighted average monthly premium across Medicare Advantage (MA) plans is projected to fall from $14.37 in 2026 to $12.00 in 2027, a decline of 16.5%. For MA plans that include drug coverage, the average monthly Medicare Part D premium after rebates is projected to fall from $11.32 to $7.00. The average premium for stand-alone Part D prescription drug plans is projected to rise from $35.09 to $36.00, an increase of less than a dollar. 18
CMS credits the end of the Part D Premium Stabilization Demonstration, a subsidy program that was narrowed for 2026 and is being discontinued. More than 99% of Medicare beneficiaries will have access to at least one MA plan and 97% to ten or more, and CMS says about eight in ten MA enrollees can stay in their current plan at the same or a lower premium. Plan enrollment is projected at 34 million people, about 47.4% of everyone in Medicare. These are plan bids and projections, and CMS notes that plan projections have historically understated actual enrollment. 18
Medicare open enrollment runs from October 15 to December 7, 2026. A lower average premium is an average across plans, and each plan's premium, drug list and provider network change every year. The Medicare Plan Finder at Medicare.gov compares them. Section 5 covers what to check before the window closes. 18
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Medicaid quality measurement shifts toward outcomes, with 37 states signed on
Status: CMS announced the initiative and the founding state group on September 25; participation is voluntary.
CMS launched an initiative it calls Investing in Health Outcomes with a founding group of 37 state partners, built on a voluntary Medicaid Quality Pledge. States commit to four principles: prioritize health outcomes over process in prevention, chronic disease management and behavioral health; shrink quality-measure inventories; move toward digital measurement using near-real-time data instead of claims and chart review; and tie financial accountability to outcome measures. 19
CMS's own May 2026 review of Medicaid managed care in 42 states found roughly 450 reporting requirements mapping to about 260 unique quality measures, most of them tracking process and utilization. The agency gave the example of diabetes control measured against three different blood sugar thresholds across states, which makes performance comparisons unreliable. The pledge is a statement of direction rather than a rule; the measures and any enforcement take shape through later state procurements and CMS workshops. 19
Five more states receive rural health transformation awards
The Rural Health Transformation Program (RHTP) is the $50 billion program created by the Working Families Tax Cuts Act that sends money to states for rural care. Five awards landed in this window.
- Missouri, more than $45 million (September 22): funding to upgrade rural hospitals, connect providers with psychiatric and maternal care specialists, and train emergency medical services professionals. 20
- South Dakota, $13 million (September 24): 12 modernization and infrastructure grants to providers in the state's Certified Community Behavioral Health Clinic program, to build a 24-hour mobile crisis response service for mental health and substance use needs. 21
- Delaware, nearly $23 million (September 24): support for all three of the state's Federally Qualified Health Centers, including electronic medical record upgrades, remote patient monitoring, cybersecurity, two new mobile health units and a passenger van. 22
- Colorado, $169.6 million (September 28): 91 grantees and about 250 projects, covering telemedicine in intensive care and inpatient settings, remote monitoring, mobile clinics, behavioral and maternal care, electronic health records, and whole-blood transfusions given before a patient reaches a hospital, with training for rural emergency providers across a network reaching 39 counties. 23
- Texas, $51 million (September 28): community programs for diabetes, cardiovascular disease, chronic respiratory disease and obesity across 68 rural hospital districts and authorities. 24
The award sizes reflect how each state chose to split its allocation: Colorado's award funds a broad set of projects, while Texas directs its money to prevention and nutrition across a large number of districts. Each state's award is a portion of its overall fiscal 2026 allocation, which CMS announced for all 50 states earlier this year.
4. Hospital M&A
Prisma Health to buy 36 urgent care centers from Novant Health
Status: The health systems announced the agreement September 24; the transaction is expected to close November 1.
Prisma Health, based in Greenville, South Carolina, agreed to acquire 36 urgent care centers in South Carolina from Winston-Salem-based Novant Health. The locations, which operate as Doctor's Care, will become Prisma Health Urgent Care when the deal closes, and about 500 employees move with them. Prisma did not disclose the price. 25
Prisma said most centers stay where they are, a small number may consolidate into nearby locations, and employees at consolidated sites will be offered jobs at neighboring centers. The system runs 20 acute care and specialty hospitals and is pursuing a separate partnership in Tennessee, where a nonbinding letter of intent signed in July would bring Chattanooga-based Erlanger Health's seven hospitals into the system with $2 billion in planned capital investment. If that deal completes, Prisma would run 27 hospitals across two states. 25
Urgent care is a cheaper front door than an emergency department, so the acquisition is about where care enters Prisma's network. The Erlanger letter of intent is a statement of intent, and the seven hospitals join only if a definitive agreement and regulatory review follow.
Other transactions that moved this week
- Tampa General takes over a 49-bed Florida hospital. Tampa General Hospital will open TGH DeSoto in Arcadia on October 1, after the DeSoto County Hospital District board selected it to assume the former DeSoto Memorial Hospital's operations, providers and staff. The system committed at least $45 million in investment in the rural facility, on a 49-year lease at $10 a year with a purchase option. The hospital serves a local population of nearly 34,000. 26
- UConn Health delays its certificate-of-need filing for two hospitals. The Farmington, Connecticut system is taking more time for due diligence on acquiring Bristol Hospital and Day Kimball Hospital in Putnam, and will delay filing its certificate of need with the state Department of Public Health. The 90-day window that opened with a late-June public notice expired this week. Bristol Health's chief executive told employees the deal remains on track to close in early 2027, and resubmitting notice requires only a fresh three-day public notice before the application is filed. 27
- Sarasota Memorial buys land for a future campus. The Sarasota County Public Hospital Board approved on September 22 the purchase of 120 acres in Manatee County for nearly $60 million, contingent on rezoning with county officials. The first phase would put a freestanding emergency department on an adjacent 10-acre parcel the board approved buying in July, with later phases for physician practices, pediatric specialty care, imaging and laboratory services. 28
5. Patient health tip: check your own coverage record before open enrollment
Action: Log in to your Marketplace or Medicare account, confirm that the plan and subsidy on the record are the ones you chose, and check that next year's drug list and provider network still fit before the enrollment window closes.
Two changes make this worth ten minutes now. CMS canceled roughly 315,000 Marketplace enrollments that it determined were unauthorized, and it is requiring consumers to authorize an agent electronically before that agent can act on an application. If your plan was changed without your knowledge, or an agent you never hired appears on your account, the account is where it shows. 14
The second change is timing. Medicare open enrollment runs October 15 to December 7, 2026, and changes to premiums, formularies and provider networks take effect January 1. CMS projects the average Medicare Advantage premium will fall while the average stand-alone Part D premium rises slightly, and both averages hide the plan you actually hold. The Medicare Plan Finder at Medicare.gov compares premiums, deductibles, benefits and drug coverage, and 1-800-MEDICARE answers the same questions by phone 24 hours a day. People who want to keep their current Medicare coverage generally do not need to re-enroll. 18
People with limited income and resources should check two programs before shopping: Medicare Savings Programs can pay Medicare premiums and may cover deductibles and copayments, and Extra Help pays most Part D drug costs. Enrolling in a Medicare Savings Program automatically qualifies someone for Extra Help. 18
Bottom line
The week's largest private financing went to clinical artificial intelligence, and the buyer being courted is the health system rather than the patient. The FDA cleared five novel drugs in six days, with a first-in-class Parkinson's treatment the one that will reach the most people. Regulation turned on the enrollment machinery itself: CMS froze new broker registrations and canceled hundreds of thousands of Marketplace enrollments, while projecting that Medicare Advantage premiums will fall for 2027. In hospitals, the notable deal was 36 urgent care centers, which says more about where systems want patients to enter care than about the hospitals they already own.
References
- 1Heidi Secures US$340M to Scale Agents Across Health Systems Globally
finance.yahoo.com
- 2OpenEvidence raises $250M at $15B valuation
beckershospitalreview.com
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- 12CDRH New - News and Updates
fda.gov
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- 25Prisma to acquire 36 urgent care centers from Novant Health
beckershospitalreview.com
- 26Tampa General to take over Florida hospital
beckershospitalreview.com
- 27UConn Health delays acquisition timeline for 2 hospitals
beckershospitalreview.com
- 28Sarasota Memorial to buy 120 acres for future Florida campus
beckershospitalreview.com
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