24/7
Buzz
Startups
VC
@work
Innovation
Opinions
Events
Promising Startups 2022
BiblioTech
Boarding Pass
Appointments
CTalk
Tech Gateways
2022 VC Survey
@Finance
Ctech Testimonials
DataTech
Projects
About
Newsletter
Contact us
RSS
Facebook
Twitter
ACCESSIBILITY
by
Homepage
FDA
Tags search
HOME
24/7
buzz
STARTUPS
VC
Tech@work
Innovation
OPINIONS
EVENTS
ABOUT
NEWSLETTER
SEARCH
CONTACT US
ACCESSIBILITY
24/7
Headlines
14:05
EU would view Israel “in the same category as China” if judicial reforms go through
13:26
This is fine? Wake up and smell the smoke!
12:18
“To some extent I am spite driven. I got so pissed at the situation and thought this has to change”
11:05
Is 2023 the year of “CMO-as-a-Service”?
More stories
Buzz
Most popular
Daily
Weekly
1
Cybersecurity company Cyren on verge of shut down after laying off entire workforce
2
Meet Israel’s most diverse tech company
3
EU would view Israel “in the same category as China” if judicial reforms go through
4
Israeli nuclear fusion startup raises $22 million Series A for clean energy solution
5
Full list of Israeli high-tech funding rounds in 2023
More news
FDA
20 stories about FDA
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
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
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
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
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
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
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
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
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
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
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
”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
More Articles