Gamida Cell Receives FDA Clearance For Lymphoma Treatment
GDA-201 is an off-the-shelf cell therapy candidate for the treatment of patients with follicular and diffuse large B cell lymphomas.
April 28, 2022
Israeli Startup Healthy.io To Bring MedTech Solution To UAE
FDA-approved smartphone app Healthy.io has partnered with UAE's Seed Group to expand its platform through the UAE.
February 17, 2022
MeMed Raises $93M To Decode Body’s Immune Response
MeMed has developed an immune-based protein signature, which distinguishes between bacterial and viral infections.
January 11, 2022
Alpha Tau Gets FDA Breakthrough Device Designation For Cancer Therapy
Founded in 2016, Alpha Tau developed a breakthrough cancer treatment called Alpha DaRT (Dіffusіng Alpha-emіtters Radіatіon Therapy).
June 13, 2021
AI Cancer Diagnostics Firm Ibex Granted FDA Breakthrough Device Designation
The designation is for the Ibex Galen platform, a solution that helps pathologists detect and grade cancer in biopsies.
June 09, 2021
BrainQ Device To Reduce Disability Post-Stroke Gets FDA ‘Breakthrough’ Status
BrainQ is set to present its findings next month from its latest randomized controlled clinical trial for ischemic stroke patients.
February 11, 2021
Zebra Medical Gets FDA Nod, Its 7th, For Surgery Planning Solution
Zebra Medical won approval for a patented orthopedic surgery planning solution that uses AI to extract bone measurements from X-ray scans.
December 14, 2020
Zebra Medical Vision Gets FDA Clearance For Mammography Solution
This is the Israeli AI imaging company's 6th FDA clearance for an automated solution that helps identify at-risk patients and helps radiologists with workflow.
July 27, 2020
Two Israeli Biomed Firms Nab FDA Approval For Separate COVID-19 Trials In US
Both RedHill BioPharma and Pluristem Therapeutics said they were given the green light for their imminent studies treating serious SARS CoV2 infections.
May 10, 2020
US-Israeli Pharma Firm NeuroRx, Relief Therapeutics Get FDA Nod For COVID-19 Trial
The FDA issued a 'study may proceed' letter 24 hours after their investigational new drug application.
March 30, 2020
FDA Clears Israeli-Developed Standing Robotic Wheelchair UPnRIDE For US Distribution
The UPnRIDE will now become available to American wheelchair users and the elderly across the country.
February 27, 2020
Migraine-Zapping Device Developed By Israeli Biomedical Firm Offers Hope For Sufferers
Founded in 2016, Theranica developed a wearable device that uses smartphone-controlled electrical pulses to create a Conditioned Pain Modulation (CPM) response.
January 23, 2020
Blood Diagnostics Firm Sight Gets FDA Nod For Device That Delivers Results In Minutes
The company says it received FDA 510(k) clearance for its OLO analyzer, a device that performs blood tests and provides lab-grade results in minutes.
December 05, 2019
US Lawmakers Call To Establish Regional FDA Office In Israel
A bipartisan group of 21 representatives sent a letter to the head of the Department of Health and Human Services urging the launch of a global office in Israel, 'a global leader in innovation.'
November 26, 2019
Biobeat Nabs FDA Clearance For Its Wearable Blood Pressure Monitors
Israeli MedTech company Biobeat announced on Monday that it received 501K clearance from the US Food and Drug Administration (FDA) for its smart and wearable wristwatch and patch that monitor blood pressure. The wearable devices measure blood pressure, oxygenation, and heart rate and can be used in hospitals, clinics, for long-term care, or at home. […]
August 27, 2019