FDA, endometrial cancer and Breakthrough Device

FDA grants breakthrough designation for Acrivon’s endometrial cancer assay
The US Food and Drug Administration (FDA) has granted breakthrough device designation for Acrivon Therapeutics’ ACR-368 OncoSignature assay designed to detect endometrial cancer patients who can benefit from the treatment of ACR-368.
Acrivon Therapeutics:FDA Grants Breakthrough Device Designation For ACR-368 OncoSignature Assay
Wednesday, announced that the FDA has granted Breakthrough Device designation for the ACR-368 OncoSignature assay for the treatment of endometrial cancer. The ACR-368-tailored OncoSignature assay is being used to identify patients most likely to respond to the company's lead drug candidate ACR-368 in an ongoing,
Acrivon Therapeutics Gets FDA Breakthrough Device Designation for Cancer Identification
Acrivon Therapeutics said the Food and Drug Administration has granted Breakthrough Device designation for its ACR-368 OncoSignature assay, an immunofluorescence assay for the identification of endometrial cancer patients who may benefit from ACR-368 treatment.
ACR-368 OncoSignature assay gains FDA breakthrough status
Acrivon Therapeutics, Inc. (NASDAQ: ACRV), a clinical stage biopharmaceutical company with a market capitalization of $184 million and an impressive 60% stock return over the past year, announced that its ACR-368 OncoSignature assay has received Breakthrough Device designation from the U.
Acrivon Therapeutics announces FDA granted BDD for ACR-368
Acrivon Therapeutics (ACRV) announced the U.S. Food and Drug Administration, FDA, has granted Breakthrough Device designation, BDD, for the
Medscape18h
FDA Warns About Diabetes Device Smartphone Alert Settings
The US Food and Drug Administration (FDA) is cautioning patients and caregivers about the potential for not receiving blood ...
dvm3609h
FDA notifies veterinarians of animal burn risk linked to human medical devices
Following a recall of grounding pads produced by Megadyne, a machinery industry company, the FDA is notifying veterinarians ...
JD Supra3d
How New Executive Orders May Affect FDA’s Medical Device Operations
Several executive orders recently signed by US President Donald Trump may have significant implications for the US Food and Drug Administration ...
Medical Device Makers Seek Exemption From Trump Tariffs
Medical device makers including Abbott, Johnson & Johnson and Medtronic want an exemption from Trump tariffs that could hit ...
Pharmabiz1h
US FDA alerts patients of potential to miss critical safety alerts due to phone settings when using smartphone-compatible diabetes devices
US FDA alerts patients of potential to miss critical safety alerts due to phone settings when using smartphone-compatible diabetes devices: Maryland Friday, February 7, 2025, 09:0 ...
Interesting Engineering on MSN1d
US FDA approves first-ever smart glasses with hearing aid for mild to moderate loss
EssilorLuxottica's Nuance Audio Glasses receive FDA clearance for OTC sales in the US, revolutionizing hearing solutions with ...
2025 Medical Device Cybersecurity Trends: What Will Shape The Industry?
What will the industry face or achieve in 2025? These trends will be critical in medical device cybersecurity.
MedPage Today11h
FDA Warns of Possible Missed Phone Alerts From Diabetes Device Apps
Some patients with diabetes may be missing critical safety alerts on their phones, the FDA warned on Wednesday.
Monthly Prescribing Reference1d
FDA: Diabetes Device Alerts May Be Missed Due to Smartphone Settings
Health care providers are urged to inform patients to periodically check their smartphone settings and to confirm that they are able to receive alerts.
medtechdive6d
FDA warns about patient monitor cybersecurity vulnerabilities
Vulnerabilities in certain Contec and Epsimed patient monitors can allow people to gain access and potentially manipulate the ...
US FDA drops web pages on improving clinical trial diversity
The U.S. Food and Drug Administration has pulled draft guidance from its website requiring companies to test medicines and ...
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EssilorLuxottica wins FDA clearance and EU approval for OTC audio glasses
EssilorLuxottica has received approval in the US and EU to market its Nuance audio glasses, a device that combines hearing ...