MedCity News

GSK Wins FDA Nod for Novel Hepatitis B Drug Offering a Potential Functional Cure

AMA Calls for Risk-Based GenAI Oversight to Protect Patients and Support Responsible Innovation

As generative AI moves toward performing increasingly consequential clinical functions, the American Medical Association (AMA) is urging the U.S. Food and Drug Administration to address a foundational question: Who is responsible for ensuring that these tools remain safe once they enter clinical practice?

By Jenna Congdon

MedCity Influencers

Wooden Jigsaw Puzzle About to Be Finished With a Blank Area Close-up Full Frame View.

Your Product Works — So Why Does It Still Fail in the Real World?

A patient's automated risk score was reassuringly green. Pulling from a sparse medical record and infrequent acute visits, the model flagged him as low risk and routed him to the default, low-touch outpatient pathway — so why was the patient actively deteriorating?

By Mitchell Frye

Artificial Intelligence, Devices & Diagnostics, Providers

FDA Official Believes GenAI-enabled Tools Will Need to Be Assessed Like a Physician

Rick Abramson, a radiologist by training and the director of FDA's Digital Health Center of Excellence said, "We ended up putting out this idea that maybe these devices are starting to behave a little bit more like me as a physician than a heart valve or a defibrillator."

By Arundhati Parmar

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Health Tech, Payers

Readily Secures $11M for Compliance Intelligence Platform

The Series A round was led by Define Ventures, with participation from Y Combinator and the California Health Care Foundation Innovation Fund.

By Marissa Plescia

BioPharma, Pharma

GSK Immunotherapy Gets Accelerated FDA Approval for Treating Rectal Cancer

The GSK cancer immunotherapy Jemperli is now approved for treating advanced cases of rectal cancer harboring a particular genetic signature. It’s a label expansion for Jemperli, which was initially approved as a treatment for endometrial cancer.

By Frank Vinluan

The Power Behind Enterprise EHR Software for Large Healthcare Systems

Enterprise EHR boosts scalability, interoperability, and governance for large healthcare systems.

By Malvika Tarnekar, Director of Product Strategy, PrognoCIS by Bizmatics Inc

MedCity Influencers

A Radical Proposal to Preserve Cell and Gene Therapy Innovation

Cell and gene therapies are amazing medical breakthroughs but if we don’t find ways to pay for them, the development pipeline will fail.

By William Shrank

Hospitals, Physicians

Report: Health System M&A Activity Remains Steady in Third Quarter

A new report on third quarter M&A activity in the healthcare sector found that this quarter’s hospital and health system transactions remained steady, with 2026 potentially set to be a top year for total annual transactions since pre-pandemic times.

By Jenna Congdon

Devices & Diagnostics, Policy

AdvaMed’s 4 Policy Priorities, According to Its CEO

AdvaMed CEO Scott Whitaker outlined four policy priorities at the MedTech Conference: tariffs, FDA user fees, payment and coverage, and cybersecurity.

By Marissa Plescia

BioPharma, Pharma

Merck KGaA’s $1.1B Silence Therapeutics Buyout Brings RNA Drug for Rare Blood Cancer

The Silence Therapeutics acquisition gives Merck KGaA a drug ready for a pivotal test in the blood disorder polycythemia vera. Silence’s RNA therapy offers a different approach and a potential dosing advantage over a Takeda Pharmaceutical product recently approved in this indication.

By Frank Vinluan

Devices & Diagnostics

With $5M, Phantom GI Plans to Develop Minimally Invasive Alternative Ostomy Surgery Device

Phantom GI, a Tel Aviv-based medical startup, is developing the PercStoma device, a minimally invasive alternative to traditional ostomy surgery. The device would target patients with bowel obstructions who might otherwise be considered ineligible for surgery.

By Jenna Congdon

MedCity Influencers

Diagnosis Is Beside the Point

Some of the thorniest problems in medicine that AI can improve have nothing to do with diagnosis. They have to do with triage.

By Michael Choma

BioPharma, Startups

Startup OMass Secures $310M to Advance Drug for Rare Endocrine Disorder

OMass’s molecule is vying to become an alternative to a Neurocrine Biosciences drug that is currently the only FDA-approved therapy for congenital adrenal hyperplasia. But Vertex Pharmaceuticals could also compete with a drug candidate from a recent acquisition.

By Frank Vinluan

Health Tech

Allswell Raises $7M to Grow LGBTQ+ Behavioral Health Platform

Allswell's seed round was led by Rethink Impact, and included participation from Magnify Ventures, Ulu Ventures and Hopelab Ventures, joining existing investors Techstars and Amboy Street Ventures.

By Marissa Plescia

MedCity Influencers

The Antibiotics Exist —The System Cannot Deliver Them

This is not a discovery problem. It is a market entry and access problem, and it is far more tractable than the pipeline crisis we spend most of our attention on.

By Mallika Auplish and Diane Shader Smith

MedCity Influencers

Exercise is Prescribed Like Advice When It Should Be Delivered Like Treatment

Health care routinely recommends movement without providing assessment, dosage, progression, and follow-up that turn good advice into usable care.

By Pradeepika Samagh

Artificial Intelligence, Physicians

UPMC Enterprises Invests in VeloSource to Expand AI-Enabled Clinician Staffing Platform

UPMC Enterprises is making a strategic investment in VeloSource with plans to further develop its AI-enabled staffing management platform.

By Jenna Congdon

Health Tech

Why Epic Is Launching a Prescription Price Comparison Tool

Epic will launch a tool in summer 2027 to help patients compare prescription cash prices and insurance costs across pharmacies.

By Marissa Plescia

BioPharma, Pharma

City Therapeutics’ Upsized IPO Raises $200M to Bring RNAi Drugs Beyond the Liver

City Therapeutics’ lead RNA interference therapy could become an alternative to blockbuster-selling anticoagulants. The company’s technology for designing RNAi drugs and delivering them to tissues throughout the body has already led to partnerships with Bausch + Lomb in eye diseases and Biogen in central nervous system disorders.

By Frank Vinluan