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Mobileye first quarter revenue falls by almost 50% as clients cut back on spending to clear excess stock

Melio names Boaz BenDavid as its first Chief Financial Officer

Check Point registers higher than expected Q1 profit helped by growth of AI-powered security platform

Microsoft explains how Generative AI impacts IP law and compliance

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Nvidia continues Israel shopping spree with acquisition of Deci

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Israeli Billionaire Hires Black Cube to Spy on Former Partner Company Vale

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Nvidia announces $700 million acquisition of Run:ai

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Nvidia on verge of completing $700 million acquisition of Run:ai

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Nagomi Security raises $23 million Series A for proactive defense platform

FDA

20 stories about FDA

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

With FDA approval in hand and Covid-19 as a test case, Israel’s Clew is ready for its money time

23.06.20|Allon Sinai

“This is a product we have been working on for years and from that perspective, Covid-19 showcased everything we have been saying,” says CEO Gal Salomon

עובדים ב מפעל של קמהדע

Israeli company Kamada to offer antibody treatment to Covid-19 patients

17.06.20|Hagar Ravet

“To the best of our knowledge, Kamada is the first company globally to complete manufacturing of a plasma-derived IgG product for the treatment of Covid-19,” says CEO of the Nasdaq listed company

גל סלומון מנכ"ל CLEW

Predictive care startup Clew gets emergency FDA approval to help treat Covid-19 patients

16.06.20|Hagar Ravet

Clew’s system can assist medical teams in remotely identifying patients who are likely to experience common coronavirus complications, including respiratory failure and hemodynamic instability

יו"ר סונוביה שוקי הרשקוביץ יהושע הרשקוביץ

Anti-Bacterial Fabric Startup Sonovia is Headed to NASDAQ

24.05.20|Sophie Shulman

Sonovia develops sonochemical coating for fabrics to make them anti-bacterial and odorless