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טראמפ במסיבת העיתונאים על התקיפה בונצואלה

FDA reverses course on Moderna flu vaccine after White House meeting

A week after declining to review Moderna’s new flu vaccine, the FDA reversed course; Politico reported the shift followed a White House meeting between Trump and the agency chief, amid a broader fight over mRNA vaccines under Health Secretary Robert F. Kennedy Jr.

News Agencies | 02.19.26

Can a pig liver save a failing human one?

As FDA-approved trials begin, researchers are testing whether a genetically engineered pig liver used outside the body can filter blood like a biological dialysis machine, giving the human liver time to rest, recover or await transplant

Tzur Gueta | 02.10.26

Aidoc founders Michael Braginsky (left), Elad Walach and Guy Reiner

FDA approves Aidoc’s first-of-its-kind AI triage platform for emergency and outpatient imaging

Powered by a single foundation model, the newly cleared solution integrates 14 acute conditions into one workflow, aiming to speed diagnoses, reduce imaging backlogs and improve patient safety in both emergency departments and ambulatory care

ynet Global | 01.22.26

Sex after 65: FDA approves libido-boosting pill for women

US regulators expand approval of Addyi to postmenopausal women; experts say treatment for low sexual desire remains complex, with limited effectiveness and side effects

Tzur Gueta | 12.17.25

Can Israeli medtech grow in the US without relocating? At least one firm plans to help

US-based The Mullings Group opens Israel office, aiming to accelerate Israeli medtech companies’ path to FDA clearance, commercialization and US market scale without forcing founders to relocate

Maayan Hoffman/The Media Line | 12.17.25

FDA plans unusual warning on COVID vaccines; experts sharply criticize move

Agency considering adding a black box warning to COVID vaccines over claims of child deaths, according to CNN; critics say data are undisclosed, process lacks transparency and decision appears politically driven

ynet Global | 12.12.25

Israeli startup QuantalX wins FDA clearance for first-of-its-kind brain function assessment system

The Delphi-MD system, combining magnetic stimulation and EEG, offers real-time, non-invasive brain health insights and sets new US regulatory standard; already in use in Israel and top US research centers, device now being deployed commercially

ynet Global | 11.22.25

Israeli at-home ultrasound tech firm Pulsenmore soars 33% after winning FDA approval

Tel Aviv-based Pulsenmore, developer of the world’s first home ultrasound device for pregnant women, surged 33% after receiving FDA clearance to market its product, paving the way for entry into the American market

Navit Zomer | 11.02.25

Trump administration to link covid shots to child deaths, alarming scientists

Trump officials plan to cite unverified reports tying COVID-19 vaccines to 25 child deaths at a CDC advisory meeting, alarming scientists who warn the shots are safe and protect against severe illness

Ynet Global | 09.12.25

New eye drops approved that restore near vision without reading glasses

The FDA has approved VIZZ, once-daily eye drops that sharpen near vision for millions with age-related presbyopia; Doctors say the treatment reduces side effects seen with earlier drops and could improve quality of life

Tzur Gueta | 08.19.25

Clinical trial finds liver damage in healthy adults taking common CBD doses, often without symptoms; researchers urge regular testing and medical oversight, especially as CBD use grows rapidly despite limited proof of benefits or long-term safety

Tzur Gueta | 07.15.25

US approves at-home cervical cancer test; Israeli pilot programs underway

FDA’s approval of the Teal Wand, a self-sampling HPV test, marks a shift toward accessible cervical cancer screening, with Israeli HMOs piloting similar programs

Tzur Gueta | 05.16.25

שבב להשתלה במוח מתוצרת נוירלינק של אילון מאסק

Cleaning house: Musk fires FDA employees overseeing Neuralink

Cutting comes as part of Musk's U.S. Department of Government Efficiency position aimed at improving processes under Trump's new administration

Oren Rice | 02.18.25

Milk without a cow comes to Israel

Israeli foodtech company Imagindairy, which already has FDA approval, gets go-ahead to market its products in Israel; Company produces protein identical to cow's milk, but without the use of animals, using an environmentally friendly method

Daniela Ginzburg | 11.27.24

Counterfeit diabetes, weight-loss drugs raise alarm after series of fatalities

Reports indicate 10 deaths and over 100 hospitalizations may be linked to counterfeit semaglutide, found in knockoffs of weight-loss drugs like Ozempic; manufacturer warns unregulated versions, not FDA-approved, could endanger public health

Tzur Gueta | 11.09.24