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Thermo fisher's preeclampsia blood test wins fda clearance

The U.S. Food and Drug Administration (FDA) has cleared the first test to detect women with risk of severe preeclampsia, a leading cause of pregnancy-...

May 19, 2023, 8:18 am

Phio's skin cancer candidate to enter clinical study, stock up

PHIO surges on the fda clearance of investigational new drug application for its lead product, PH-762, ...

May 17, 2023, 12:47 pm

Samsung's irregular heart rhythm notification feature for the galaxy watch receives fda clearance

Samsung announced today that its Irregular Heart Rhythm Notification feature for the Galaxy Watch has received ...

May 8, 2023, 10:51 am

Sequana medical announces fda clearance of ind application for dsr® 2.0 for treatment of congestive heart failure

PRESS RELEASE MOJAVE study on track to start in Q2 2023 as planned, with initial data by year-end Randomized, controlled study in US seeking to confir...

May 2, 2023, 5:14 am

Nano-x imaging shares soar on fda clearance of medical imaging system

Nano-X Imaging (Nanox) shares jumped more than 60% after the medical imaging technology company announced it has received US Food and Drug Administrat...

May 1, 2023, 11:46 am

Radnet’s quantib b.v. subsidiary receives fda clearance for its quantib prostate™ 3.0 software

LOS ANGELES, May 01, 2023 (GLOBE NEWSWIRE) — RadNet, Inc., (NASDAQ: RDNT) today announced that it has received ...

May 1, 2023, 10:00 am

Abbott (abt) gets fda clearance for freestyle libre 3 reader

Abbott (ABT) receives the fda clearance for a standalone reader to be used for the FreeStyle Libre 3 iC...

April 17, 2023, 9:08 am

Masimo's (masi) new fda clearance to boost patient monitoring

Masimo's (MASI) receipt of the FDA's De Novo grant is expected to combat opioid overdoses by boosting patient monitoring....

April 4, 2023, 1:42 pm

Butterfly network shares take flight on fda clearance of ai-enabled lung tool

Butterfly Network Inc shares added almost 30% after the company announced on Monday that its AI-enabled lung tool Auto B-line Counter has received 510...

April 4, 2023, 11:03 am

Abbott (abt) to pair cgm sensors & aid system on fda clearance

Abbott Laboratories (ABT) receives fda clearance for the integration of its iCGM system sensors with au...

March 13, 2023, 1:44 pm

Vertex (vrtx) to begin clinical study on type i diabetes drug

Vertex Pharmaceuticals (VRTX) receives fda clearance to begin clinical development of VX-264, which has...

March 10, 2023, 10:43 am

Dexcom pummeled on a new fda clearance for key rival abbott laboratories

Dexcom stock toppled Monday after the FDA cleared Abbott Laboratories to pair its body-worn glucose monitors with automated insulin pumps. The post De...

March 6, 2023, 12:18 pm

Hyperfine, inc. receives fda clearance for updated software to further improve diffusion-weighted imaging

Swoop® Portable MR Imaging® system positioned to offer even greater clinical utility in neurocritical care GUILFORD, Conn., Feb. 28, 2023 (GLOBE NEW...

February 28, 2023, 1:55 pm

Chemomab (cmmb) stock gains 30% on fda clearance

There's potentially positive news for the medical community as well as investors of Chemomab (NASDAQ: CMMB ) today. CMMB stock is moving higher becaus...

February 21, 2023, 11:43 am

Exelixis (exel), sairopa obtains ind clearance for adu-1805

Exelixiss' EXEL) partner Sairopa gets fda clearance for its IND application for the oncology drug ADU-1...

February 14, 2023, 1:33 pm

Onl therapeutics receives u.s. fda clearance of investigational new drug application for onl1204 ophthalmic solution

First-in-class small molecule Fas inhibitor with unique mechanism of action is designed to provide neuroprotection for retinal cells ANN ARBOR, Mich.,...

February 1, 2023, 12:00 pm

Bioaegis therapeutics announces fda clearance of ind for its ‘inflammation regulator protein,’ gelsolin, for the treatment of ards

NORTH BRUNSWICK, N.J., Jan. 26, 2023 (GLOBE NEWSWIRE) — BioAegis Therapeutics, Inc., a clinical-stage company developing therapies for inflammatory ...

January 26, 2023, 7:05 pm

Why prenetics global stock is skyrocketing today

The company announced a key fda clearance....

January 10, 2023, 11:32 am

Kronos® air disinfection technology manufacturer receives fda 510(k) class ii medical device clearance for the destruction of viruses, bacteria, and allergens.

fda clearance Provided After Review Of Patented Air Disinfection Technology Proven Effective At Elimina...

January 10, 2023, 11:18 am

Biomea fusion announces fda clearance of investigational new drug (ind) application for covalent menin inhibitor bmf-219 in type 2 diabetes

COVALENT-111, a Phase I/II clinical trial in patients with type 2 diabetes, already underway in Canada, will now activate sites in the US As previousl...

December 14, 2022, 9:30 pm


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