FDA

20 stories about FDA
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

24.08.20|CTech
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
אריה בלדגרין דוקטור מנכ"ל ו ממייסדי קייט פארמה

”Exits are not a Strategy. I Never put up a ‘For Sale’ Sign”

23.05.20|Sophie Shulman and Golan Hazani
Arie Belldegrun, chairman of UroGen Pharma, talks about catching Covid-19 and gaining FDA approval in the midst of a global pandemic
מימין מיכאל ברגינסקי אלעד וולך גיא ריינר AIDOC

FDA Greenlights Use of Aidoc’s Imaging Technology to Detect Covid-19

10.05.20|Hagar Ravet
The technology developed by the Tel Aviv-based startup can help radiologists detect lung anomalies associated with coronavirus in any CT scan that contains the lung or part of the lung
קור שולץ מנכ"ל טבע 9.11.19

Teva Receives FDA Approval for Migraine Autoinjector

29.01.20|Sophie Shulman
Teva’s anti-migraine injection was approved in late 2018 but struggled to establish a market share due to both Amgen and Eli Lilly offering a similar drug with an autoinjector
סרטן שד גידול הקפאה אייסקיור

IceCure Receives Additional FDA Clearance For Its Cancer Freezing Technology

07.01.20|Adi Pick
IceCure develops an ultrasound imaging-guided probe that injects liquid nitrogen into a tumor, freezing its tissue in a process called cryoablation
surgeon מנתח augmedics

Surgical AR Company Augmedics Receives FDA Clearance

25.12.19|Adi Pick
The company’s headset projects X ray-like 3D visualization of the patient in real-time, allowing surgeons to see through the patient's skin, muscle tissue, and bone