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24/7
Headlines
18:17
Why Israeli tech companies are moving to Miami
17:11
Mediaocean acquires Innovid for $500M, delisting it from the NYSE
16:48
Full list of Israeli startup M&As in 2024
16:46
Wiz acquires Dazz for $450 million to strengthen AI-driven cloud security
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1
Cyera doubles valuation to $3B with $300M Series D, total funding hits $600M in seven months
2
Claroty veterans launch Twine with $12M in Seed funding from Dell and Wiz founders to deploy AI cyber workers
3
Salesforce seals $1.9 billion cash deal to acquire cloud backup company Own
4
Wiz acquires Dazz for $450 million to strengthen AI-driven cloud security
5
Prompt Security raises $18 million Series A to protect enterprises from GenAI risks
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FDA
20 stories about FDA
”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
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
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
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
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
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
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.
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
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
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
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
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
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
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
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
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.
Kadimastem Gets FDA Orphan Drug Designation for ALS Drug
04.11.18
|
Lilach Baumer
The biotech company is currently conducting an early clinical trial in Israel and expects results in mid-2019
Teva Shares Rise Following FDA Approval of Migraine Drug
16.09.18
|
Dror Reich
Teva’s new migraine drug is forecasted to bring in $500 million in sales annually
FDA Approves Brainsway’s Magnetic Stimulation Headset for OCD Treatment
19.08.18
|
CTech
Brainsway develops non-invasive medical devices that are worn on the head like helmets to apply magnetic stimulation to treat brain disorders
Teva Wins FDA Approval for First Generic EpiPen
19.08.18
|
Lilach Baumer
EpiPens were sold for less than $60 when Mylan acquired the injectors in 2007. Market Monopoly enabled the company to hike its price up to around $300 a unit today
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