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FDA

56 stories about FDA

Imagindairy’s animal-free dairy gets green light in Israel
26.11.24|James SpiroThe news follows a successful FDA approval earlier this year
Teva has sights on $12.2 billion Humira market after receiving FDA approval for arthritis injection
25.02.24|Meir OrbachThe Israeli pharma company and Iceland’s Alvotech announced that the SIMLANDI injection has been approved as an interchangeable biosimilar to Humira for the treatment of adult rheumatoid arthritis, juvenile idiopathic arthritis, adult psoriatic arthritis, adult ankylosing spondylitis, Crohn’s disease, adult ulcerative colitis, adult plaque psoriasis, adult hidradenitis suppurativa and adult uveitis
Elon Musk's Neuralink implants brain chip in human for the first time
30.01.24|ReutersThe U.S. Food and Drug Administration had given the company clearance last year to conduct its first trial to test its implant on humans, a critical milestone in the startup's ambitions to help patients overcome paralysis and a host of neurological conditions
Foodtech startup Imagindairy receives FDA approval for animal-free milk proteins
04.01.24|Meir OrbachImagindairy creates animal-free milk proteins from microorganisms via proprietary precision-fermentation technology that allows the production of a broad spectrum of dairy analogs, from raw milk to cheese, without involving animals
Nanox shares skyrocket on back of FDA approval for X-ray system
01.05.23|CTechThe Israeli medical imaging company received clearance for Nanox.ARC, a stationary X-ray system intended to produce tomographic images
FDA authorizes marketing of Medasense's NOL technology to measure pain in anesthetized patients
28.02.23|CTechThe agency's clearance paves the way for the commercialization in the US of the sensor platform and advanced AI algorithms that convert complicated data into a patient's 'Signature of Pain'
How can startups leverage controversial FDA approval for Alzheimer’s drug?
17.06.21|Dr. Micha BreakstoneThe 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 SpiroThe 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 OrbachThe 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 SternlichtThe 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 SpiroThe 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 SpiroThis 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 OrbachGroup 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 Gafnihe 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|CTechTMS 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 ShulmanModerna 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 SpiroThe 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 RavetClew’s system can assist medical teams in remotely identifying patients who are likely to experience common coronavirus complications, including respiratory failure and hemodynamic instability

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