FDA grants 510(k) clearance to HARMONIC HD 1000i surgical device

As FDA sidesteps the question of Galleri’s clinical benefit, NCI’s Letai has “some concerns”

As the oncology community waits with bated breath for a possible FDA approval of GRAIL’s Galleri test, NCI Director Anthony Letai has a lot to say about multi-cancer detection tests—particularly Galleri.

October 14, 2026

NCI Regulatory News

Letai: MCEDs are a “great ideal”—alas, the data don’t support widespread use
“Projecting sub-ideal tests across a large population can cause harm,” Letai says, as Galleri cruises toward FDA approval

As the debate around Galleri, the multi-cancer detection test developed by GRAIL Inc., rages on, fueled most recently by the full-steam-ahead support it has received from regulatory and legislative bodies, NCI Director Anthony Letai has turned his attention to the available data.

October 09, 2026

Vol.52 No.37

By Jacquelyn Cobb

Oncologist Rachna Shroff endows award to outlast her cancer diagnosis
“Because of my health, I have a profound desire to see this endowment come to fruition now”

When Rachna Shroff learned that she was facing a serious illness, she began thinking about what she wanted to leave behind.

October 09, 2026

Vol.52 No.37

By Claire Marie Porter

Clinical

Cancer vaccine policy in limbo as CDC keeps canceling advisory meetings

For more than a year, professional societies have been trying to fill the role of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices, a panel that develops recommendations related to vaccines, including those that prevent cancer.

Oncology has a semantics problem: How do we define “early stage”?

I recently found myself asking a question that I thought had an obvious answer: What is early-stage cancer?

October 09, 2026

Vol.52 No.37

By Raja M. Flores

MUSC startup brings preclinical imaging into the light
New technology lets cancer researchers watch experiments unfold in real time

Some of the most important moments in cancer research happen in seconds. A new imaging technology developed by MUSC startup OncoBLAZE lets researchers see those moments as they happen.

October 09, 2026

Vol.52 No.37

By Hayley Kamin

FDA grants 510(k) clearance to HARMONIC HD 1000i surgical device

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As FDA sidesteps the question of Galleri’s clinical benefit, NCI’s Letai has “some concerns”

Letai: MCEDs are a “great ideal”—alas, the data don’t support widespread use
“Projecting sub-ideal tests across a large population can cause harm,” Letai says, as Galleri cruises toward FDA approval

Oncologist Rachna Shroff endows award to outlast her cancer diagnosis
“Because of my health, I have a profound desire to see this endowment come to fruition now”

Cancer vaccine policy in limbo as CDC keeps canceling advisory meetings

Oncology has a semantics problem: How do we define “early stage”?

MUSC startup brings preclinical imaging into the light
New technology lets cancer researchers watch experiments unfold in real time

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FDA grants 510(k) clearance to HARMONIC HD 1000i surgical device

YOU MAY BE INTERESTED IN

As FDA sidesteps the question of Galleri’s clinical benefit, NCI’s Letai has “some concerns”

Letai: MCEDs are a “great ideal”—alas, the data don’t support widespread use“Projecting sub-ideal tests across a large population can cause harm,” Letai says, as Galleri cruises toward FDA approval

Oncologist Rachna Shroff endows award to outlast her cancer diagnosis“Because of my health, I have a profound desire to see this endowment come to fruition now”

Cancer vaccine policy in limbo as CDC keeps canceling advisory meetings

Oncology has a semantics problem: How do we define “early stage”?

MUSC startup brings preclinical imaging into the lightNew technology lets cancer researchers watch experiments unfold in real time

Never miss an issue!

Login

Letai: MCEDs are a “great ideal”—alas, the data don’t support widespread use
“Projecting sub-ideal tests across a large population can cause harm,” Letai says, as Galleri cruises toward FDA approval

Oncologist Rachna Shroff endows award to outlast her cancer diagnosis
“Because of my health, I have a profound desire to see this endowment come to fruition now”

MUSC startup brings preclinical imaging into the light
New technology lets cancer researchers watch experiments unfold in real time