Medical Devices; Cardiovascular Devices; Classification of the Hyperoxia Monitoring Device Adjunct to Pulse Oximetry
Published . Updated .
The Food and Drug Administration (FDA) is classifying the hyperoxia monitoring device adjunct to pulse oximetry into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the hyperoxia monitoring device adjunct to pulse oximetry. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Directly affected
- No company is named in this report.
Indirectly affected
- ATYR ATYR PHARMA INC COM NEW
GA selected ATYR as a RELATED security because its canonical security name directly matches this event's themes: pharma. This is an explainable DERIVED market relationship, not a claim that the security was named in the source article.
- ACHC ACADIA HEALTHCARE COMPANY INC
GA selected ACHC as a RELATED security because its canonical security name directly matches this event's themes: healthcare. This is an explainable DERIVED market relationship, not a claim that the security was named in the source article.
- ASND ASCENDIS PHARMA A/S
GA selected ASND as a RELATED security because its canonical security name directly matches this event's themes: pharma. This is an explainable DERIVED market relationship, not a claim that the security was named in the source article.
- BBIO BRIDGEBIO PHARMA INC
GA selected BBIO as a RELATED security because its canonical security name directly matches this event's themes: pharma. This is an explainable DERIVED market relationship, not a claim that the security was named in the source article.
- DVA DaVita HealthCare Partners, Inc.
GA selected DVA as a RELATED security because its canonical security name directly matches this event's themes: healthcare. This is an explainable DERIVED market relationship, not a claim that the security was named in the source article.
- GEHC GE HEALTHCARE TECHNOLOGIES I
GA selected GEHC as a RELATED security because its canonical security name directly matches this event's themes: healthcare. This is an explainable DERIVED market relationship, not a claim that the security was named in the source article.
Price reaction, T-5 to T+3
The Food and Drug Administration (FDA) is classifying the hyperoxia monitoring device adjunct to pulse oximetry into class II (special controls). The special controls that apply to the device type are identified in this order and will be p…
Source: Federal Register
aTYR PHARMA (ATYR) since this story, compared with the market
Since the first closing price after “Medical Devices; Cardiovascular Devices; Classification of the Hyperoxia Monitoring Device Adjunct to Pulse Oximetry,” aTYR PHARMA (ATYR) is -39.54%. The S&P 500 fund (SPY) is -1.36% over the same days, a -38.18% difference versus the market.
Who reported a aTYR PHARMA (ATYR) trade near this story
- Gilbert Cisneros sell BridgeBio Pharma (BBIO) ($1,001 - $15,000). That is 7 days before publication, inside 30 days. The filing is listed beside the story “Medical Devices; Cardiovascular Devices; Classification of the Hyperoxia Monitoring Device Adjunct to Pulse Oximetry.”
- Rohit Khanna buy GE HealthCare Technologies (GEHC) ($1,001 - $15,000). That is 25 days before publication, inside 30 days. The filing is listed beside the story “Medical Devices; Cardiovascular Devices; Classification of the Hyperoxia Monitoring Device Adjunct to Pulse Oximetry.”
Public disclosure filings, not a recommendation. The filing link is the source document. News use of these reports still sits under 5 U.S.C. § 13107(c).
Who gains and who loses around aTYR PHARMA (ATYR)
Companies carried with this story
- ATYR aTYR PHARMA
For “Medical Devices; Cardiovascular Devices; Classification of the Hyperoxia Monitoring Device Adjunct to Pulse Oximetry,” aTYR PHARMA (ATYR) is linked, with no stored direction, medium confidence. Reason on file: GA selected ATYR as a RELATED security because its canonical security name directly matches this event's themes: pharma. This is an explainable DERIVED market relationship, not a claim that the security was named in the source article
- ACHC Acadia Healthcare
In “Medical Devices; Cardiovascular Devices; Classification of the Hyperoxia Monitoring Device Adjunct to Pulse Oximetry,” Acadia Healthcare (ACHC) is linked, with no stored direction, medium confidence. Reason on file: GA selected ACHC as a RELATED security because its canonical security name directly matches this event's themes: healthcare. This is an explainable DERIVED market relationship, not a claim that the security was named in the source article
- ASND Ascendis Pharma A/S
In “Medical Devices; Cardiovascular Devices; Classification of the Hyperoxia Monitoring Device Adjunct to Pulse Oximetry,” Ascendis Pharma A/S (ASND) is linked, with no stored direction, medium confidence. Reason on file: GA selected ASND as a RELATED security because its canonical security name directly matches this event's themes: pharma. This is an explainable DERIVED market relationship, not a claim that the security was named in the source article
- BBIO BridgeBio Pharma
BridgeBio Pharma (BBIO) is linked, with no stored direction, medium confidence in the 6 Oct 2026 story “Medical Devices; Cardiovascular Devices; Classification of the Hyperoxia Monitoring Device Adjunct to Pulse Oximetry.” Reason on file: GA selected BBIO as a RELATED security because its canonical security name directly matches this event's themes: pharma. This is an explainable DERIVED market relationship, not a claim that the security was named in the source article
- DVA Davita
In “Medical Devices; Cardiovascular Devices; Classification of the Hyperoxia Monitoring Device Adjunct to Pulse Oximetry,” Davita (DVA) is linked, with no stored direction, medium confidence. Reason on file: GA selected DVA as a RELATED security because its canonical security name directly matches this event's themes: healthcare. This is an explainable DERIVED market relationship, not a claim that the security was named in the source article
- GEHC GE HealthCare Technologies
In “Medical Devices; Cardiovascular Devices; Classification of the Hyperoxia Monitoring Device Adjunct to Pulse Oximetry,” GE HealthCare Technologies (GEHC) is linked, with no stored direction, medium confidence. Reason on file: GA selected GEHC as a RELATED security because its canonical security name directly matches this event's themes: healthcare. This is an explainable DERIVED market relationship, not a claim that the security was named in the source article
aTYR PHARMA (ATYR)
“Medical Devices; Cardiovascular Devices; Classification of the Hyperoxia Monitoring Device Adjunct to Pulse Oximetry” (6 Oct 2026) reaches aTYR PHARMA (ATYR) through this story.
What ties aTYR PHARMA (ATYR) to the headline is this: GA selected ATYR as a RELATED security because its canonical security name directly matches this event's themes: pharma. This is an explainable DERIVED market relationship, not a claim that the security was named in the source article
A second company, Acadia Healthcare (ACHC), is listed for a different reason: GA selected ACHC as a RELATED security because its canonical security name directly matches this event's themes: healthcare. This is an explainable DERIVED market relationship, not a claim that the security was named in the source article
Dates and price levels for aTYR PHARMA (ATYR)
ACHC traded between 26.75 and 32.03 across 20 sessions. The latest close on file is 30.20. ASND traded between 219.69 and 240.84 across 20 sessions. The latest close on file is 229.99. ATYR traded between 0.17 and 0.41 across 20 sessions. The latest close on file is 0.17.
What the saved facts support for aTYR PHARMA (ATYR)
54 out of 100
“Medical Devices; Cardiovascular Devices; Classification of the Hyperoxia Monitoring Device Adjunct to Pulse Oximetry” scores 54 out of 100. The score uses 2 sources, and 6 linked companies.