XTalks

JANUARY 26, 2024

As of October 19, 2023, there were 692 FDA-approved devices linked to AI/ML , underscoring the expanding role of these technologies in healthcare. It promotes unique insights and improvements in tumor biology understanding through the collaboration of biological and computer scientists.

Research 118

Research Gene Editing Gene Genetics 118

The Pharma Data

DECEMBER 15, 2020

” Last week, the FDA approved a different at-home test, but it requires samples to be mailed to a lab to get the results. The new Ellume COVID-19 Home Test approved Tuesday detects SARS-CoV-2 virus protein fragments on nasal swab samples from any person 2 years of age or older, according to the FDA.

FDA Approval 52

FDA Approval Radiology Doctors Doctor 52

XTalks

JUNE 12, 2023

Additionally, Abbott launched over 125 new products in 2022, in conjunction with a series of FDA approvals. This system is the first and only FDA-approved heart failure monitoring system that enables physicians to track changes in pulmonary artery pressure. The CardioMEMs HF system was another crucial launch for Abbott.

FDA Approval 98

FDA Approval Production Sales In-Vitro 98

Intouch Solutions

JUNE 30, 2022

The Roblox pseudo-metaverse now includes a partnership with ADHD therapy (gizmodo.com) – Roblox is partnering with Akili Interactive, creators of EndeavorRx (a game that is an FDA-approved ADHD treatment for children 8-12), to “create new ways for patients to engage in health through the Roblox platform.”

Pharmacy 52

Pharmacy Radiology Cosmetics Manufacturing 52

XTalks

AUGUST 30, 2022

Nusinersen was the first FDA-approved treatment for spinal muscular atrophy (SMA), the first approved nucleic-acid therapeutic for a neurologic disease and the first approved drug to correct defective splicing. Direct CNS administration is also FDA-approved for multiple small molecules and ASOs.

Trials 83

Trials Drug Delivery Drugs Gene 83

XTalks

APRIL 6, 2021

The Harmony pulmonary valve is implanted using a thin catheter with a collapsed Harmony valve on the end. The catheter carrying the valve is inserted through a vein in the groin or in the neck into the right side of the heart and into the RVOT where it is placed into position.

FDA Approval 98

FDA Approval Radiology Containment Clinical Trials 98

pharmaphorum

AUGUST 9, 2022

Magnetic resonance imaging (MRI) technology specialist Bot Image has won FDA approval for its artificial intelligence-powered software ProstatID, used for the detection and diagnosis of prostate cancer. The FDA approval means that “the path for implementation is open,” according to Jones.

Radiology 83

Radiology FDA Approval Clinical Trials Clinical Trials 83

XTalks

JUNE 30, 2023

“The approval of Ultravist-300 and -370 in contrast-enhanced mammography gives physicians a new imaging option where conventional mammography might not be enough,” said Dr. Konstanze Diefenbach, head of Radiology Research and Development at Bayer, in the company’s news release. “We

FDA Approval 98

FDA Approval Radiology Trials Life Science 98

XTalks

NOVEMBER 7, 2022

Immunofluorescent staining of CTCs is a CTC isolation method that has been used since the first US Food and Drug Administration (FDA) approval in 2013 for the CellSearch ® CTC enumeration platform. Regulatory Approvals for CTC-Based Assays in Oncology. Table 1: Some examples of cfDNA-based assays that are approved by the US FDA.

Clinical Trials 98

Clinical Trials Clinical Trials Trials FDA Approval 98

pharmaphorum

NOVEMBER 16, 2021

Now, FDA approval means that it can continue to be sold outside of the public health emergency. Using the AI, ETTs are automatically identified in chest X-ray images, providing feedback to the clinician on positioning within seconds and warning them if it hasn’t been place correctly.

FDA Approval 145

FDA Approval Radiology Development 145

pharmaphorum

DECEMBER 15, 2022

Digital health company MedCognetics has picked up an FDA approval for QmTRIAGE, its artificial intelligence-powered software for detecting breast cancer in medical images. The company said QmTRIAGE can help alleviate a chronic shortage in radiology services around the world.

Radiology 59

Radiology FDA Approval Licensing Licensing 59

XTalks

JANUARY 19, 2024

Regulatory bodies have demonstrated preparedness for the surge in radiopharmaceuticals as evidenced by inaugural Chemistry, Manufacturing and Controls (CMC) Development and Readiness Pilot (CDRP) programs to expedite commercial manufacturing, US Food and Drug Administration (FDA) approvals and marketing authorizations.

DNA 66

DNA Radiology FDA Approval Development 66

XTalks

JULY 10, 2024

Related: Abbott’s HPV Test Gets FDA Approval for High-Risk HPV Detection and Cervical Cancer Screening Hepatitis C Drug Market Trends The global hepatitis C drug market was valued at $7.86 billion in 2018 and is projected to reach $9.84 billion by 2032, growing at a compound annual growth rate (CAGR) of 1.8 percent.

RNA 97

RNA In-Vitro Genotype Marketing 97

XTalks

MARCH 27, 2023

The primary endpoints were global cure (consisting of clinical cure, radiological cure and mycological eradication) at 14 days for the European Medical Agency (EMA), and a 30-day all-cause mortality for the US FDA. Rezafungin met the endpoints outlined by both the EMA and FDA.

Clinical Trials 98

Clinical Trials Clinical Trials Branding Trials 98

The Pharma Data

DECEMBER 8, 2020

Orphan drug designation is the first step in receiving orphan drug exclusivity following approval, which confers seven years of market exclusivity for the relevant indication. It is characterized by progressive fibrosis, lung scarring, and a radiological pattern known as usual interstitial pneumonia, or UIP.

Drugs 40

Drugs FDA Approval Marketing Containment 40

The Pharma Data

APRIL 7, 2023

Food and Drug Administration (FDA) has accepted for review the Supplemental New Drug Applications (sNDAs) for BRAFTOVI® (encorafenib) + MEKTOVI® (binimetinib) for patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test. In the U.S., Ono Pharmaceutical Co.

FDA Approval 40

FDA Approval Drugs Medicine Genetics 40

The Pharma Data

NOVEMBER 18, 2020

. “Today’s authorization for a complete at-home test is a significant step toward FDA’s nationwide response to COVID-19,” Jeff Shuren, director of FDA’s Center for Devices and Radiological Health, said in a statement.

FDA Approval 52

FDA Approval Vaccination Vaccine Genetics 52