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Blue-and-white Black Hat: How Israel came to dominate cyber's biggest conference

Base44 founder Maor Shlomo launches cancer research fund after losing his mother to the disease

Israeli chip company Xsight Labs raises $300 million at $2.8 billion valuation

“We are prepared to be very aggressive”: Check Point signals appetite for a major cyber acquisition

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ServiceNow continues layoffs as it restructures around AI

2

“We want to replace Datadog”: groundcover raises $100 million at $500 million valuation as AI reshapes observability

3

AI security startup Onyx raises $113 million Series B at $640 million valuation

4

Cyber unicorn Cyera acquires Oasis Security in $1 billion deal

5

Jared Kushner’s Affinity Partners sells $343 million Phoenix stake after fivefold return

FDA

20 stories about FDA

ד"ר ליאור שאלתיאל מנכ"ל נוראקסון

Can damaged nerves grow back? An Israeli biotech is betting they can

21.07.26|Hagai Gilboa , Maor Shalom Swisa

Haifa-based NurExone is preparing for human trials of an experimental therapy that uses engineered exosomes to restore function after spinal cord and optic nerve injuries.

מייסדי איידוק Aidoc מימין גיא ריינר אלעד וולך מיכאל ברגינסקי

FDA clears Aidoc’s foundation-model AI for broad clinical triage

The system flags multiple acute conditions from CT scans within one unified platform.

מייסדי איידוק Aidoc מימין גיא ריינר אלעד וולך מיכאל ברגינסקי

Aidoc receives Breakthrough Device Designation from FDA for multi-triage imaging AI

“The new technology means our mission is at hand - to support physicians in every patient encounter,” said Elad Walach, Co-Founder and CEO.

איל אפרגן imagindairy

Imagindairy’s animal-free dairy gets green light in Israel

26.11.24|James Spiro

The news follows a successful FDA approval earlier this year

מניית טבע בורסת ניו יורק מניה

Teva has sights on $12.2 billion Humira market after receiving FDA approval for arthritis injection

25.02.24|Meir Orbach

The Israeli pharma company and Iceland’s Alvotech announced that the SIMLANDI injection has been approved as an interchangeable biosimilar to Humira for the treatment of adult rheumatoid arthritis, juvenile idiopathic arthritis, adult psoriatic arthritis, adult ankylosing spondylitis, Crohn’s disease, adult ulcerative colitis, adult plaque psoriasis, adult hidradenitis suppurativa and adult uveitis

אלון מאסק מייסד סטארטאפ ניוראלינק neuralink

Elon Musk's Neuralink implants brain chip in human for the first time

30.01.24|Reuters

The U.S. Food and Drug Administration had given the company clearance last year to conduct its first trial to test its implant on humans, a critical milestone in the startup's ambitions to help patients overcome paralysis and a host of neurological conditions

Imagindairy founders

Foodtech startup Imagindairy receives FDA approval for animal-free milk proteins

04.01.24|Meir Orbach

Imagindairy creates animal-free milk proteins from microorganisms via proprietary precision-fermentation technology that allows the production of a broad spectrum of dairy analogs, from raw milk to cheese, without involving animals

Nanox shares skyrocket on back of FDA approval for X-ray system

The Israeli medical imaging company received clearance for Nanox.ARC, a stationary X-ray system intended to produce tomographic images

חדר ניתוח ערוץ אקזיטוואלי

FDA authorizes marketing of Medasense's NOL technology to measure pain in anesthetized patients

The agency's clearance paves the way for the commercialization in the US of the sensor platform and advanced AI algorithms that convert complicated data into a patient's 'Signature of Pain'

מיכה ברקסטון NeuraLight

How can startups leverage controversial FDA approval for Alzheimer’s drug?

17.06.21|Dr. Micha Breakstone

The decision to approve Biogen's Alzheimer’s drug signifies a watershed moment for neurology, highlighting an unprecedented opportunity for neurology-focused startups

Ibex Medical Analytics granted ‘Breakthrough Device Designation’ by the FDA, fast-tracking its approval

09.06.21|James Spiro

The U.S Food and Drug Administration formally acknowledged its Galen platform and the potential benefit it has on American patients

רונן אקהויז ראפיד מדיקל

Rapid Medical announces $50 million series D

25.05.21|Meir Orbach

The father and son-led company, which develops neurovascular medical devices, is eyeing global commercial expansion following the fundraising led by MicroPort

אייסקיור הליך הקפאת גידול בשד

Israel’s IceCure granted FDA Breakthrough Medical Device designation

04.04.21|Hezi Sternlicht

The decision puts the company’s tumor-freezing technology on the fast track for final approval

גל סלומון מנכ"ל ומייסד Clew

CLEW Medical receives FDA approval for AI-based tech to support adult ICU patient assessment

03.02.21|James Spiro

The device, CLEWICU, is the first-ever cleared device for predicting patient deterioration based on hemodynamic instability

Michael Braginsky Aidoc

Aidoc granted AI ‘industry-first’ FDA clearance for triage of incidental pulmonary embolism

21.10.20|James Spiro

This marks the company’s sixth FDA clearance, paves the way for the commercial use of its triaging and notification algorithms

Israel-based V-Wave raises $98 million for heart failure beating shunt

23.09.20|Meir Orbach

Group of global healthcare investors backs the company as it gears up for clinical trials

The public deserves a healthier healthcare industry

27.08.20|Moav Gafni

he coronavirus pandemic has called the FDA's bluff. The public now knows that when necessary, it is entirely possible to make significant shortcuts that save years of development and billions of dollars

בריינסוויי Brainsway

Jerusalem-based BrainsWay receives FDA clearance for magnetic stimulation system to help smokers quit

TMS treatment involves sitting in a chair and wearing a helmet containing a patented H-coil for 20-minutes. The coil stimulates the brain by creating a temporary magnetic field that generates excitation or inhibition of neurons deep inside the brain

הדמיה חיסון תרופה קורונה covid 19

Place your bets: Which company will reach a Covid-19 vaccine first?

02.08.20|Sophie Shulman

Moderna may be creating all the buzz, but it is the youngest and least experienced of the contestants, playing an all or nothing game

אוהד ארזי מנכ"ל זברה מדיקל

Israel’s Zebra Medical Vision gets its first FDA clearance in oncology

28.07.20|James Spiro

The new approval marks the sixth time the medical imaging company has earned FDA clearance