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FDA

20 stories about FDA
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
מוסף תרופה תרופות בית מרקחת

RedHill Receives FDA Approval for H. Pylori Gastric Drug

05.11.19|Tzally Greenberg
H. pylori is a type of drug-resistant gastric bacteria linked with increased risks of developing ulcers and stomach cancer
סטיבן מנושין סטיבן מנוצ'ין שר האוצר ארה"ב

Steven Mnuchin, Israeli Health Officials Discuss Establishment of Israeli FDA Branch

29.10.19|Sophie Shulman
The FDA, which approves all medical devices and formulations in the U.S., has very few branches outside of the U.S.
ביוביט שעון מדבקה biobeat

Biobeat Receives FDA Greenlight for Blood Pressure Monitoring Wristband

27.08.19|Lilach Baumer
Israel-based Biobeat develops sensing and remote monitoring products with the aim of improving the quality of medical care both in-hospital and at the patient’s home
ועידת MIND THE DATA 2016 אייל גורה מייסד ויו״ר Zebra Medical

Zebra Medical Receives FDA Clearance for its Brain Hemorrhage Alert Technology

17.06.19|Adi Pick
Zebra Medical uses artificial intelligence and machine learning algorithms for the automated analysis of radiological scans such as X-rays, CT scans, and MRI
מכשיר ביתי בדיקה דום נשימה שינה איתמר מדיקל

Itamar Medical Receives FDA Approval for Sleep Apnea Monitor

06.06.19|Tzally Greenberg
The newly approved product is a one-use, $100 version of the company’s existing product, which retails for $5,000
default image

Zebra Medical Receives FDA Clearance for Automated Chest X-Ray Analysis Algorithm

13.05.19|Meir Orbach
Israel-based Zebra Medical develops AI-based algorithms for the automated analysis of medical scans such as X-ray, CT, and MRI
מטה טבע פתח תקווה

FDA Approves Teva’s Generic Nasal Spray for Opioid Overdose

21.04.19|Lilach Baumer
Commonly known as Narcan, the spray is considered a life-saving medication, and Teva’s drug is the first generic product approved that does not require medical training to use
מוסף ניתוח מנתחים רופא רופאים חדר ניתוח

Heart Care 3D Visualization Startup CathWorks Gets FDA Approval

26.12.18|CTech
The company's device enables physicians to visualize oxygen delivery to the heart in real-time using a specialized X-ray test
צוות ביופ מדיקל Biop Medical

Cervical Cancer Detection Startup Biop Gets FDA Approval

18.12.18|CTech
Biop developed a device that maps the cervix and identifies cancerous and precancerous cells in epithelial tissues
מטה טבע פתח תקווה

Teva, Celltrion Gain FDA Approval for Generic Blood Cancer Bio-Drug

29.11.18|Lilach Baumer
Called Truxima, the drug has been approved to treat several conditions of non-Hodgkin’s lymphoma
תרופה מזרק אפיפן מיילן אלרגיה

Teva’s Generic EpiPen Now Available in the U.S. in Limited Numbers

28.11.18|Lilach Baumer
In August, the Israel-headquartered drugmaker won approval to market the first generic EpiPen auto-injectors in the U.S.
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