STAT

JUNE 25, 2024

The 12-lead electrocardiogram device, called the Kardia 12L ECG System, is a hand-held version of the standard ECG device usually found in hospitals and used to diagnose heart conditions.

FDA 138

FDA Documentation Hospitals 138

STAT

JUNE 17, 2024

The vaccine, which will be sold under the name Capvaxive, is designed to protect against pneumococcal pneumonia, which hospitalizes about 150,000 adults in the United States every year and kills about 1 in 20 who develop it, according to the National Foundation for Infectious Diseases. Read the rest…

Vaccines 145

Vaccines FDA Hospitals 145

STAT

JANUARY 4, 2024

At issue is the Research, Abuse, Diversion, and Addiction-Related Surveillance system, or RADARS, which was originally created as in-house monitoring program by Purdue Pharma and later sold to the Denver Health and Hospital Authority. Continue to STAT+ to read the full story…

FDA 125

FDA Hospitals 125

pharmaphorum

JUNE 30, 2022

The FDA’s decision not to approve Spero Therapeutics’ oral antibiotic tebipenem Hbr for adults with complicated urinary tract infections (cUTI) further increases the threat of antibiotic resistance, according to a GlobalData analyst.

FDA 119

FDA Hospitals 119

STAT

APRIL 27, 2023

In public, hospitals rave about artificial intelligence. They trumpet the technology in press releases, plaster its use on billboards, and sprinkle AI into speeches touting its ability to detect diseases earlier and make health care faster, better, and cheaper. But on the front lines, the hype is smashing into a starkly different reality.

Hospitals 112

Hospitals FDA 112

STAT

SEPTEMBER 11, 2024

  Developers can’t fully guarantee the algorithm’s performance, explained Califf, because an AI model’s performance evolves over time and performs differently in different hospitals’ patient populations, unlike a drug. And that model drift is “happening in health systems.

Hospitals 143

Hospitals FDA 143

pharmaphorum

AUGUST 21, 2020

It’s mission accomplished for Novartis after the FDA approved ofatumumab for multiple sclerosis, completing a project where the former cancer drug has been repurposed. The FDA approved ofatumumab under the brand name Kesimpta for people living with relapsing forms of multiple sclerosis.

FDA 116

FDA Hospitals 116

pharmaphorum

DECEMBER 9, 2020

Reviewers from the FDA have given their blessing to the Pfizer/BioNTech COVID-19 vaccine ahead of a key meeting tomorrow – but the regulator noted that there are still uncertainties about whether the shot can stop the disease from spreading. The post FDA reviewers back Pfizer/BioNTech COVID-19 vaccine ahead of panel appeared first on.

Vaccines 111

Vaccines FDA Adverse Reactions Documentation 111

STAT

SEPTEMBER 19, 2023

A team at the Children’s Hospital of Philadelphia, led by Alan Flake, is the closest to human trials — their device is a bag filled with sterile fluid, which contains the fetus and is connected to tubes providing oxygen and nutrition.

FDA 145

FDA Hospitals 145

STAT

JUNE 24, 2024

Once FDA regulators decide a device is safe and effective, companies and researchers then attempt to track how the device performs in the real world. This makes it incredibly difficult for researchers to observe device performance trends in claims data, and for hospitals to reach out to patients when specific devices are recalled.

Insurance 131

Insurance Hospitals FDA 131

STAT

JULY 25, 2024

Tara Bannow, our hospitals and insurance reporter, joins us to talk about a new investigation that shows how UnitedHealth wields its unrivaled physician empire to boost its profits and expand its influence. Is Viking Therapeutics an attractive acquisition target? And is Adam good at math?

Insurance 113

Insurance FDA Hospitals 113

Pharmacy Times

DECEMBER 22, 2022

Intravenous tocilizumab (Actemra; Genentech) has been approved for the treatment of COVID-19 in individuals who are hospitalized and receiving systemic corticosteroids and supplemental oxygen.

Hospitals 123

Hospitals FDA 123

Hospital Pharmacy Europe

MARCH 6, 2023

Following the FDA approval, the company has created the Reata Education, Access, and Care Helpline ( REACH ), an integrated specialty pharmacy and patient services program, designed to help eligible patients access prescribed Reata medicines.

FDA 97

FDA Specialty Pharmacies Labelling Hospitals 97

STAT

AUGUST 23, 2023

  The panel, whose advice the FDA typically follows, voted that the system developed by ReCor Medical was safe and effective. Luke’s Hospital of Kansas City, said regarding Medtronic’s device. It voted that the benefits of a system developed by Medtronic, however, did not outweigh the risks.

FDA 98

FDA Hospitals 98

STAT

JULY 31, 2024

Mount Sinai, a leading hospital network in New York City, has mounted an extraordinary behind-the-scenes campaign to blunt the fallout over revelations about its controversial research project in which brain biopsies are taken from patients undergoing deep brain stimulation, STAT has learned.

Documentation 145

Documentation FDA Hospitals 145

Pharmacy Times

JUNE 29, 2022

The approval eliminates the need for traditional nitric oxide tanks in the hospital setting.

Hospitals 123

Hospitals FDA 123

pharmaphorum

OCTOBER 25, 2021

Hard on the heels of some impressive clinical trial results, Luminopia has won FDA approval for its digital therapeutic (DTx) for amblyopia or lazy eye in children that is based on watching TV shows. The post Luminopia scores FDA approval for TV-based amblyopia therapy appeared first on. Photo by Jessica Lewis on Unsplash.

FDA 111

FDA Hospitals 111

Outsourcing Pharma

OCTOBER 26, 2020

The agency has approved the antiviral drug Veklury (remdesivir), produced by Gilead, for hospitalized patients 12 years and over diagnosed with the virus.

FDA 105

FDA Hospitals 105

STAT

MARCH 18, 2025

I self-referred for GLP-1s years ago after seeing advertisements, and even though I am a diabetic, what followed were horrific health outcomes: hospitalizations, extensive procedures, scans, MRIs, pancreatitis, anemia, and thousands in medical expenses. So I understand why new Health and Human Services Secretary Robert F. Kennedy Jr.

Hospitals 81

Hospitals FDA 81

pharmaphorum

JULY 6, 2022

The FDA has granted a priority review to Roche’s T-cell engager Lunsumio as a treatment for follicular lymphoma (FL), setting up a decision on the drug by 29 December. The post FDA to decide on Roche’s lymphoma drug Lunsumio before year-end appeared first on.

FDA 104

FDA Chemotherapy Hospitals 104

STAT

DECEMBER 18, 2023

Her son, Declan, who turns 2 years old in January, survived a life-threatening episode of cardiac arrest that sent him to a hospital emergency room a year ago. Jamie Dubuque faces the future with a mixture of gratitude and trepidation.

Hospitals 142

Hospitals FDA 142

STAT

SEPTEMBER 17, 2024

Panelists include leaders from the Food and Drug Administration, the Centers for Disease Control and Prevention, a Harvard Medical School teaching hospital, and electronic health record giant Epic Systems.

Medical Schools 130

Medical Schools FDA Hospitals 130

Hospital Pharmacy Europe

FEBRUARY 23, 2023

The post FDA approves Syfovre for geographic atrophy in advanced age-related macular degeneration appeared first on Hospital Pharmacy Europe. Geographic atrophy (GA) is an advanced form of age-related macular degeneration and which leads to progressive and irreversible loss of vision.

FDA 98

FDA Immunization Hospitals 98

Fierce Healthcare

AUGUST 7, 2024

Ohio-based University Hospitals Health System (UH) has teamed up with healthcare AI company Aidoc to catch conditions like pulmonary embolism, coronary artery calcification and intracrani | Aidoc's AI-based image analysis technology will be deployed in University Hospitals.

Hospitals 55

Hospitals FDA 55

STAT

OCTOBER 2, 2023

Critical information, like unique device identifiers that help hospitals keep track of implants in patients, was often missing. She quickly realized that the software was too old and clunky to identify report patterns that would help the agency shut down a product before hurting patients.

Insurance 123

Insurance FDA Hospitals 123

Pharmafile

FEBRUARY 29, 2024

Spero Therapeutics has announced that it has gained US Food and Drug Administration (FDA) clearance for the investigational new drug (IND) application to assess SPR206 in a phase 2 clinical study.

FDA 64

FDA Hospitals 64

STAT

JULY 31, 2023

… House Republicans have drafted drug-shortage legislation that differs significantly from the approach Democrats propose to stem shortages of chemotherapies and other critical medicines that hospitals typically use , STAT explains. Republicans as being primarily driven by synthetic opioids including illicit fentanyl.

FDA 95

FDA Chemotherapy Hospitals 95

STAT

MAY 15, 2023

In the early days of the Covid pandemic, gravely ill patients began to fill America’s hospitals. In a 2021 APC survey, more than 80 pharmacies nationwide reported they had provided compounded versions of those essential drugs to hospitals under the temporary guidance.

Compounding Pharmacies 98

Compounding Pharmacies Compounding Hospitals FDA 98

The Checkup by Singlecare

MARCH 31, 2025

Ozempic and Wegovy (and Rybelsus , which is oral semaglutide) are GLP-1 receptor agonists (glucagon-like peptide-1 receptor agonists, commonly referred to as GLP-1s) and are the only FDA-approved drugs that contain the active ingredient semaglutide. Some facilities add B12 to their compounds, in addition to semaglutide.

Compounding 52

Compounding Compounding Pharmacies FDA Adverse Reactions 52

STAT

MAY 4, 2023

The Pfizer vaccine has also been tested to protect infants in their first six months of life — the age group at highest risk of being hospitalized with RSV — and is expected to gain FDA approval for that population later this year. Continue to STAT+ to read the full story…

Vaccines 98

Vaccines FDA Hospitals 98

STAT

JULY 18, 2023

WASHINGTON — Medicare has a new proposal to pay hospitals more to stockpile essential drugs — an idea that comes as doctors report running low on critical chemotherapies and other drugs. But Medicare has its own new idea: paying hospitals to create a “buffer stock” of 86 medicines that HHS deems critical.

Hospitals 98

Hospitals Chemotherapy FDA 98

STAT

JANUARY 31, 2024

Ideally, he said, the FDA should be able to both stay on top of safety concerns and avoid unnecessarily restricting access to drugs. I think there are definitely situations for many drugs where you can say, no, we’re not really at the right balance, and the FDA should be taking a more aggressive stance in promoting patient safety.

Adverse Reactions 116

Adverse Reactions FDA Labelling Hospitals 116

Digital Pharmacist

OCTOBER 24, 2022

The FDA protects public health by ensuring the efficacy and safety of human and veterinary drugs, including biological products and medical devices. It is critical for the FDA to continue to develop new advances in therapies to aid our communities in order to achieve better lives through better health. Date of Approval: 9/30/2022.

FDA 75

FDA Adverse Reactions Pharmaceutical Companies Pharmaceutical Companies 75

STAT

AUGUST 20, 2024

You’re reading the web edition of STAT’s Health Tech newsletter, our guide to how technology is transforming the life sciences.    Sign up to get it  delivered in your inbox every Tuesday and Thursday.

Hospitals 105

Hospitals FDA 105

pharmaphorum

FEBRUARY 1, 2022

If LVEF is 40% or less a patient is considered to have heart failure with reduced ejection fraction (HFrEF), sometimes known as systolic heart failure, which is generally diagnosed in hospital. Eko says it will be submitted to the FDA for approval later his year. The study is published in The Lancet Digital Health.

Mayo Clinic 140

Mayo Clinic Hospitals FDA 140

STAT

AUGUST 20, 2024

biopharmaceutical companies conducted clinical trials with China’s military organizations, and specifically with medical centers and hospitals affiliated with the People’s Liberation Army’s,” according to an Aug.   “For over a decade, it appears that U.S.

Hospitals 137

Hospitals FDA 137

pharmaphorum

NOVEMBER 3, 2021

A real-world study of digital therapeutic (DTx) for opioid use disorder has found that patient show used it had 46% fewer hospital stays than a control group, saving more than $2,700 over a nine-month period.

Hospitals 132

Hospitals FDA 132