20 stories about FDA
אלון מאסק מייסד סטארטאפ ניוראלינק neuralink

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

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 ARC

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
Joseph Mossel

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
לב פועם

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
מואב ורדי

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
גל סלומון clew

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