FDA Medical Device Approvals

News

US approves 1st at-home cervical cancer screening device

Teal Health gains FDA approval for cervical cancer screening device

The US Food and Drug Administration (FDA) has secured approval to Teal Health’s at-home vaginal sample self-collection device, Teal Wand, for cervical cancer screening. This prescription device claims to be the first and only product of its kind in the US,

Medical Device Network on MSN · 2d

ConsumerAffairs · 1d

FDA approves first at-home cervical cancer screening device

MPR · 20h

FDA Clears Self-Collection Device for Cervical Cancer Screening

Orchestra BioMed Holdings - Breakthrough Device Designation Gives Speculative Optimism

Orchestra BioMed's AVIM earns FDA breakthrough designation, sparking investor optimism. Click here to read why OBIO stock is ...

pharmaphorum19d

FDA committee doesn’t recommend Abbott’s heart device for approval

Abbott Laboratories has announced that its implantable heart device, MitraClip, has not been recommended for approval by reviewers at the US Food and Drug Administration. Clinical trials ...

MassDevice12d

Element Sciences earns FDA premarket approval for wearable defibrillator patch

Element Science announced today that it received FDA pre-market approval for its Jewel patch wearable cardioverter ...

KOBI-TV NBC5 / KOTI-TV NBC215h

FDA approves at home cervical cancer screening device

The FDA has approved the first at-home device for cervical cancer screening to test for HPV. HPV is the cause of nearly all ...

14dOpinion

FDA Issues New Guidance For AI-Enabled Medical Devices: Why The Threats Are Real And Alarming

AI is a transformational force in healthcare, but without cybersecurity as its foundation, it becomes a high-stakes gamble.

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