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Delphinus PMA OKd for Breast Screener

[ Price : $8.95]

FDA approves a Delphinus Medical Technologies PMA for its SoftVue 3D Whole Breast Ultrasound Tomography System for use as an adjun...

Advisors to Consider Moderna Vaccine Booster

[ Price : $8.95]

The FDA Vaccines and Related Biological Products Advisory Committee will consider 10/14 Modernas request for an EUA for a Covid va...

Groups Oppose McMurry-Heath as FDA Commissioner

[ Price : $8.95]

Some 26 healthcare organizations led by Public Citizen say they oppose the potential nomination of BIO CEO Michelle McMurry-Heath ...

FDA Alert on ENFit Low Dose Tip Syringes

[ Price : $8.95]

FDA issues a safety alert about the potential for overdose, under certain clinical use conditions, when using ENFit low dose tip s...

FAQ on Sodium Citrate Blood Specimen Collection Tubes

[ Price : $8.95]

FDA issues an online Frequently Asked Questions document on the shortage of sodium citrate blood specimen collection tubes used in...

Life Spine ProLift Expandable Spacer Cleared

[ Price : $8.95]

FDA clears a Life Spine 510(k) for the ProLift micro Expandable Spacer System for endoscopic transforaminal and posterior lumbar i...

Contract Testing Lab Hit with Warning Letter

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FDA issues a Warning Letter to contract testing laboratory Missouri Analytical Laboratories after a May inspection cited significa...

Quanterix Gets Breakthrough for Alzheimers Test

[ Price : $8.95]

FDA grants Quanterix a breakthrough device designation for its Simoa phospho-Tau 181 blood test as an aid in diagnosing Alzheimers...

Protagonist Therapeutics Hold Lifted on Trials

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FDA removes a Protagonist Therapeutics clinical hold on the company's rusfertide clinical tumor-detection studies.

FDA Broadens Dextenza to Include Ocular Itching

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FDA approves an Ocular Therapeutix supplemental NDA to broaden Dextenzas (dexamethasone ophthalmic insert) label to add an additio...