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FDA panel endorses first-of-a-kind cancer blood test from Grail

FDA panel endorses first-of-a-kind cancer blood test from Grail

A federal health panel has endorsed an experimental cancer test that uses a blood sample to detect multiple forms of the disease
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FDA Panel Endorses Grail's Multi-Cancer Blood Test for Individuals Aged 50 and Older

FDA Panel Endorses Grail's Multi-Cancer Blood Test for Individuals Aged 50 and Older

A federal advisory panel to the Food and Drug Administration (FDA) has endorsed Grail Inc.’s Galleri blood test, designed to detect signs of various cancers in apparently healthy individuals aged 50 and older. The panel voted 7-2, with one abstention, concluding that the DNA-based test offers more potential benefits than risks, despite acknowledging that more study is needed. The Galleri test does not diagnose cancer directly but identifies signals that may indicate the presence of one of over 50 types of tumors. A positive result necessitates further medical evaluation to confirm a cancer diagnosis. This endorsement marks the first time a federal advisory group has backed such an experimental multi-cancer blood test. The FDA is not bound by the panel's advice but typically considers it heavily in its final decisions, which are expected in a few months.
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FDA Advisory Panel Endorses Grail's DNA-Based Cancer Blood Test Amidst Efficacy Concerns

FDA Advisory Panel Endorses Grail's DNA-Based Cancer Blood Test Amidst Efficacy Concerns

A federal advisory panel to the Food and Drug Administration (FDA) has endorsed Grail Inc.'s Galleri test, a DNA-based blood test designed to detect signs of various cancers in seemingly healthy individuals. The panel voted 7-2, with one abstention, concluding that the test offers more potential benefits than risks, despite significant questions regarding its efficacy. The Galleri test does not diagnose cancer directly but identifies signals that may indicate the presence of over 50 types of cancer, including those for which no routine screenings currently exist, such as liver and ovarian cancer. Individuals receiving a positive result would require further medical evaluation. This endorsement marks the first time a federal advisory group has supported such an experimental approach to multi-cancer detection. The FDA is expected to make a final decision on the test in the coming months, which could significantly broaden its availability in the U.S.
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US FDA advisers endorse Grail cancer test's benefits in key vote

US FDA advisers endorse Grail cancer test's benefits in key vote

By Padmanabhan Ananthan and Kamal Choudhury Sept 23 (Reuters) - A panel of outside experts advising the US FDA said on Wednesday the benefits of Grail's blood-based cancer detection test outweigh its risks, paving the way for a potential landmark approval in cancer screening.
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Former Johnson Johnson CEO Alex Gorsky Invests in AI Biotech Enveda's $311 Million Funding Round

Former Johnson Johnson CEO Alex Gorsky Invests in AI Biotech Enveda's $311 Million Funding Round

Former Johnson Johnson CEO Alex Gorsky Invests in AI Biotech Enveda's $311 Million Funding Round
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Palo Alto Networks Recognized as Visionary Leader in U.S. Healthcare Cybersecurity by Frost Sullivan

Palo Alto Networks Recognized as Visionary Leader in U.S. Healthcare Cybersecurity by Frost Sullivan

Palo Alto Networks has been named a Visionary Leader in Frost & Sullivan's Frost Radar™: Healthcare Infrastructure Cybersecurity in the United States, 2026. The company achieved the top Innovation Index score (5.00) and a Growth Index score of 4.60, positioning it higher than any other provider evaluated. Frost & Sullivan highlighted Palo Alto Networks' ability to move beyond merely identifying vulnerable medical devices to actively applying compensating controls through existing network infrastructure. This is particularly critical for legacy and difficult-to-patch clinical devices, such as infusion pumps or imaging systems, which often have uptime constraints, require FDA revalidation for changes, or run on older operating systems. The company's Device Security, evolved from its Zingbox-based Medical IoT origins, uses next-generation firewalls as both sensors to identify vulnerable devices and enforcement points to block exploits, effectively compressing remediation times from months to minutes without m...
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Cellares and Seoul National University Hospital Partner for Automated Gene-Modified HSPC Therapy Manufacturing

Cellares and Seoul National University Hospital Partner for Automated Gene-Modified HSPC Therapy Manufacturing

Cellares and Seoul National University Hospital Partner for Automated Gene-Modified HSPC Therapy Manufacturing
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Fate Therapeutics Receives $15 Million Grant from California Institute for Regenerative Medicine to Advance Lupus Nephritis Treatment

Fate Therapeutics Receives $15 Million Grant from California Institute for Regenerative Medicine to Advance Lupus Nephritis Treatment

Fate Therapeutics, a clinical-stage biopharmaceutical company, has been awarded a $15.0 million grant by the California Institute for Regenerative Medicine (CIRM) through its CLIN2 program. This funding is designated to support the clinical development of RECLAIM-LN, the company's Phase 2, potentially registrational trial for FT819. FT819 is an off-the-shelf CAR T-cell therapy aimed at treating refractory moderate-to-severe Systemic Lupus Erythematosus (SLE) with Lupus Nephritis (LN). Lupus Nephritis is a severe manifestation of SLE, affecting approximately 150,000 patients in the United States and is a leading cause of morbidity and mortality. The RECLAIM-LN study, which will enroll approximately 53 patients, seeks to evaluate the efficacy and safety of FT819, particularly focusing on the proportion of participants achieving complete renal response at Week 26. The study was developed in collaboration with the FDA under FT819's Regenerative Medicine Advanced Therapy (RMAT) designation.
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MIT Researchers Develop Edible Batteries for Internal Medical Devices

MIT Researchers Develop Edible Batteries for Internal Medical Devices

Researchers at the Massachusetts Institute of Technology (MIT) have developed edible batteries designed to power internal medical devices. These batteries, made from magnesium and molybdenum trioxide, can generate a peak voltage of 1.84 volts and function within an animal's stomach for up to three days. The technology has been tested on pigs, where it successfully powered a wireless tag in the throat that communicated with a receiver 1.5 meters away. Additionally, it charged a capsule that electrically stimulated the stomach for 20 minutes, a method used to treat gut conditions affecting stomach emptying. The primary goal of this innovation is to support temporary internal devices, such as those tracking medication use or delivering electrical stimulation, without requiring surgical removal. The research team emphasizes that this system eliminates the need for retrieval procedures, reduces the risk of device retention, and minimizes electronic waste in the gastrointestinal tract, marking a significant step...
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Grail's cancer blood test faces high-stakes FDA review

Grail's cancer blood test faces high-stakes FDA review

A blood test to hunt signs of multiple cancers in healthy people is facing its first major U.S. regulatory hurdle
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Epitel's REMI Neuro Monitoring System Selected for FDA's READI-Home Innovation Challenge

Epitel's REMI Neuro Monitoring System Selected for FDA's READI-Home Innovation Challenge

Epitel, Inc. has announced that its REMI™ Neuro Monitoring Home Health Hub has been chosen by the U.S. Food and Drug Administration (FDA) to participate in the Reducing Readmissions through Device Innovation for the Home (READI-Home) Innovation Challenge. Epitel is one of the initial two companies to advance to the interaction phase of this program. The READI-Home Innovation Challenge, part of the FDA Center for Devices and Radiological Health's (CDRH) Home as a Health Care Hub Initiative, seeks medical devices that can support patients and caregivers in their homes after an acute hospital stay. The interaction phase offers early engagement with the FDA, providing rapid feedback to refine device design and testing for home-use indications. Epitel's REMI system is a wireless, wearable electroencephalography (EEG) system designed for extended monitoring in home and ambulatory settings for individuals aged six and older. It aims to provide continuous neurological monitoring to assess for potential seizures, p...
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Goldman Sachs Initiates Neutral Coverage on Tempus AI Amidst Diagnostic Growth and Data Monetization Challenges

Goldman Sachs Initiates Neutral Coverage on Tempus AI Amidst Diagnostic Growth and Data Monetization Challenges

Goldman Sachs Initiates Neutral Coverage on Tempus AI Amidst Diagnostic Growth and Data Monetization Challenges