K223900 · Clinical Innovations, LLC · FMK · Feb 24, 2023 · General, Plastic Surgery
Device Facts
Record ID
K223900
Device Name
babyLance Safety Heelstick (BLM, BLN, BLP)
Applicant
Clinical Innovations, LLC
Product Code
FMK · General, Plastic Surgery
Decision Date
Feb 24, 2023
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 878.4850
Device Class
Class 2
Attributes
Pediatric
Indications for Use
The babyLance safety heelstick is a single-use incision device used to obtain a blood sample from the heel of a neonate or infant. babyLance has a sharps prevention feature to protect the user from a needlestick injury.
Device Story
The babyLance is a sterile, single-use, spring-loaded incision device for neonatal heel sticks. It consists of a stainless-steel blade housed in a plastic casing with an ergonomic design. Operation involves removing a trigger lock, positioning the device on the infant's heel, and depressing a trigger to activate the blade. The device uses mechanical energy to perform the incision; the blade automatically retracts and locks within the housing post-activation to prevent sharps injuries and reuse. It is intended for use by trained healthcare professionals in clinical settings. The device facilitates blood collection for newborn screening tests. By automating the incision depth and retraction, it provides a consistent, safe method for blood sampling, minimizing the risk of needlestick injuries to the user and trauma to the infant.
Clinical Evidence
Bench testing only. Evidence includes biocompatibility (ISO 10993-1), shelf-life, shipping, usability, and simulated use validation. Results demonstrate the device meets all requirements and performs equivalently to the predicate.
Indicated for obtaining blood samples from the heel of neonates and infants (including premature infants). Contraindicated in cases of local edema, previously traumatized skin at the site, cyanosis, impaired perfusion, infection at the site, or when puncturing the calcaneus.
Regulatory Classification
Identification
The regulation covers four types of blood lancets: (a) Single use only blood lancet with an integral sharps injury prevention feature; (b) Single use only blood lancet without an integral sharps injury prevention feature; (c) Multiple use blood lancet for single patient use only; and (d) Multiple use blood lancet for multiple patient use. All are defined as disposable or reusable devices comprised of a blade attached to a base used to puncture the skin to obtain a drop of blood for diagnostic purposes.
Special Controls
*Classification.* Class II (special controls). The special controls are:(i) The design characteristics of the device must ensure that the structure and material composition are consistent with the intended use and must include a sharps injury prevention feature.
(ii) Mechanical performance testing must demonstrate that the device will withstand forces encountered during use and that the integral sharps injury prevention feature will irreversibly disable the device after one use.
(iii) The device must be demonstrated to be biocompatible.
(iv) Sterility testing must demonstrate the sterility of any device component that breaches the skin (
*e.g.,* blade).(v) Labeling must include:
(A) Detailed descriptions, with illustrations, of the proper use of the device and its sharps injury prevention feature.
(B) Handwashing instructions for the user before and after use of the device.
(C) Instructions on preparation (
*e.g.,* cleaning, disinfection) of the skin to be pierced.(D) Instructions for the safe disposal of the device.
(E) Labeling must be appropriate for the intended use environment.
(
*1* ) For those devices intended for health care settings, labeling must address the health care facility use of these devices, including how these lancets are to be used with personal protective equipment, such as gloves.(
*2* ) For those devices intended for use in the home, labeling must be written so that it is understandable to lay users.(vi) Labeling must also include the following statements, prominently placed:
(A) “For use only on a single patient. Discard the entire device after use.”
(B) “Warning: Not intended for more than one use. Do not use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested.”
(b)
*Single use only blood lancet without an integral sharps injury prevention feature* —(1)*Identification.* A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, non-reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.(2)
*Classification.* Class II (special controls). The special controls are:(i) The design characteristics of the device must ensure that the structure and material composition are consistent with the intended use and address the risk of sharp object injuries and bloodborne pathogen transmissions.
(ii) Mechanical performance testing must demonstrate that the device will withstand forces encountered during use.
(iii) The device must be demonstrated to be biocompatible.
(iv) Sterility testing must demonstrate the sterility of any device component that breaches the skin (
*e.g.,* blade).(v) Labeling must include:
(A) Detailed descriptions, with illustrations, of the proper use of the device.
(B) Handwashing instructions for the user before and after use of the device.
(C) Instructions on preparation (
*e.g.,* cleaning, disinfection) of the skin to be pierced.(D) Instructions for the safe disposal of the device.
(E) Labeling must be appropriate for the intended use environment.
(
*1* ) For those devices intended for health care settings, labeling must address the health care facility use of these devices, including how these lancets are to be used with personal protective equipment, such as gloves.(
*2* ) For those devices intended for use in the home, labeling must be written so that it is understandable to lay users.(vi) Labeling must also include the following statements, prominently placed:
(A) “For use only on a single patient. Discard the entire device after use.”
(B) “Warning: Not intended for more than one use. Do not use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested.”
(c)
*Multiple use blood lancet for single patient use only* —(1)*Identification.* A multiple use capable blood lancet intended for use on a single patient that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.(2)
*Classification.* Class II (special controls). The special controls are:(i) The design characteristics of the device must ensure that:
(A) The lancet blade can be changed with every use, either manually or by triggering a blade storage unit to discard the used blade and reload an unused blade into the reusable base; and
(B) The structure and material composition are consistent with the intended use and address the risk of sharp object injuries and bloodborne pathogen transmissions and allow for validated cleaning and disinfection.
(ii) Mechanical performance testing must demonstrate that the device will withstand forces encountered during use.
(iii) The device must be demonstrated to be biocompatible.
(iv) Sterility testing must demonstrate the sterility of any device component that breaches the skin (
*e.g.,* blade).(v) Validation testing must demonstrate that the cleaning and disinfection instructions are adequate to ensure that the reusable lancet base can be cleaned and low level disinfected.
(vi) Labeling must include:
(A) Detailed descriptions, with illustrations, of the proper use of the device.
(B) The Environmental Protection Agency (EPA) registered disinfectant's contact time for disinfectant use.
(C) Handwashing instructions for the user before and after use of the device.
(D) Instructions on preparation (
*e.g.,* cleaning, disinfection) of the skin to be pierced.(E) Instructions on the cleaning and disinfection of the device.
(F) Instructions for the safe disposal of the device.
(G) Instructions for use must address the safe storage of the reusable blood lancet base between uses to minimize contamination or damage and the safe storage and disposal of the refill lancet blades.
(H) Labeling must be appropriate for the intended use environment.
(
*1* ) For those devices intended for health care settings, labeling must address the health care facility use of these devices, including how these lancets are to be used with personal protective equipment, such as gloves.(
*2* ) For those devices intended for use in the home, labeling must be written so that it is understandable to lay users.(vii) Labeling must also include the following statements, prominently placed:
(A) “For use only on a single patient. Disinfect reusable components according to manufacturer's instructions between each use.”
(B) “Used lancet blades must be safely discarded after a single use.”
(C) “Warning: Do not use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested. The cleaning and disinfection instructions for this device are intended only to reduce the risk of local use site infection; they cannot render this device safe for use for more than one patient.”
(d)
*Multiple use blood lancet for multiple patient use* —(1)*Identification.* A multiple use capable blood lancet intended for use on multiple patients that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.(2)
*Classification.* Class III (premarket approval).(3)
*Date PMA or notice of completion of a PDP is required:* A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 22, 2024, for any multiple use blood lancet for multiple patient use described in paragraph (d)(1) of this section that was in commercial distribution before May 28, 1976, or that has, on or before May 22, 2024, been found to be substantially equivalent to a multiple use blood lancet for multiple patient use described in paragraph (d)(1) of this section that was in commercial distribution before May 28, 1976. Any other multiple use blood lancet for multiple patient use shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
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February 24, 2023
Alex Garrett Regulatory Affairs Specialist 747 West 4170 South Murray, Utah 84123
Re: K223900
Trade/Device Name: babyLance Safety Heelstick (BLM, BLN, BLP) Regulation Number: 21 CFR 878.4850 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: FMK Dated: December 15, 2022 Received: December 28, 2022
Dear Alex Garrett:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jessica Carr -S
for Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known): K223900
Device Name: babyLance® Heel Incision Device
Indications for Use:
The babyLance safety heelstick is a single-use incision device used to obtain a blood sample from the heel of a neonate or infant. babyLance has a sharps prevention feature to protect the user from a needlestick injury.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _______________ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
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Image /page/3/Picture/0 description: The image shows the logo for Clinical Innovations. The logo features a stylized, abstract shape composed of interconnected segments in shades of blue and green. To the right of the shape, the words "CLINICAL INNOVATIONS" are written in a clear, sans-serif font. Below the company name, the tagline "for MOM. for BABY. for LIFE." is displayed in a smaller font size.
# (5) 510(k) Summary
| Manufacturer Name | Clinical Innovations, LLC |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Manufacturer Address | 747 West 4170 South, Murray, UT 84123, USA |
| Manufacturer contact information | P. 801-268-8200<br>Toll Free: 888-268-6222<br>https://www.clinicalinnovations.com |
| 510(k) Number | TBD |
| Contact Person | Alex Garrett<br>Regulatory Affairs Specialist<br>agarrett@laborie.com |
| Preparation Date | 16-DEC-2022 |
| Trade Name | babyLance Safety Heelstick Device |
| Common Name | Disposable Safety Lancet |
| Classification Name | Single Use Only Blood Lancet With An Integrated Sharps Injury Prevention<br>Feature (21 CFR 878.4850, Product Code FMK) |
| Predicate | BabyLance Heel Incision Device, 510K number K130132 |
### Device Description
The babyLance™ safety heelstick is a sterile, single-use device designed to be a one-handed, automated incision device for use in heel sticks of newborn and neonatal infants (also called preemie infants). A heel stick is a procedure in which a newborn baby's heel is pricked for blood collection for use in newborn screening tests.
The babyLance™ is constructed with a Nylon housing which holds the stainless-steel cutting blade and deployment mechanism. The babyLance™ has a sharps prevention feature to protect the user from a sharps injury. It is supplied in a sterile polypropylene tray with a Tyvek™ lid.
The outside plastic casing is designed to be ergonomic for the user and compatible with an infant's foot. The user breaks off the trigger lock from the device is positioned on the newborn's heel and the user depresses the trigger to activate the blade to make an incision. Once the blade has been triggered, the blade is automatically retracted within the housing. The device is discarded in a sharps container after use.
| BabyLance | Product Code | Body/Trigger Colors |
|---------------|--------------|---------------------|
| Micro preemie | BLM | Yellow/Lime Green |
| Preemie | BLP | Pink/White |
| Newborn | BLN | Blue/Green |
# Table 1: Device Variants
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Image /page/4/Picture/1 description: The image shows the logo for Clinical Innovations. The logo features a stylized, abstract shape composed of four curved segments in shades of gray and green. To the right of the shape, the words "CLINICAL INNOVATIONS" are written in a sans-serif font, with "CLINICAL" stacked above "INNOVATIONS". Below the company name is the tagline "forMOM. forBABY. forLIFE." in a smaller, lighter font.
# Indications for Use
As provided in the Instructions for Use (IFU) (See Appendix I), for babyLance Safety Heelstick Device:
The babyLance safety heelstick is a single-use incision device used to obtain a blood sample from the heel of a neonate or infant. babyLance has a sharps prevention feature to protect the user from a needlestick injury.
## Contraindications
As provided in the IFU (See Appendix I), for babyLance Safety Heelstick Device, the device is not to be used in the following conditions:
- Presence of local edema
- Puncturing previously traumatized skin in the same location
- Presence of cyanosis or impaired perfusion
- Puncturing the calcaneus
- . Infection at the site
### Patient Population
babyLance Safety Heelstick Devices are to be used on newborns and premature infants.
#### Predicate Comparison
Materials, Principals of Operation, Indications for Use Contraindications and Patient Population for babyLance are the same as the predicate device.
| Table 2: Substantial Equivalence Comparison Table | | | |
|---------------------------------------------------|--|--|--|
| | | | |
| Technological<br>Characteristics | babyLance (predicate) | babyLance<br>(device under review) |
|------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Clearance Date | February 11, 2013 | TBD |
| 510(k) number | K130132 | TBD |
| 510(k) submitter | MediPurpose Pte. Ltd.<br>15 Hoe Chiang Road<br>#12-02 Tower Fifteen<br>Singapore, SINGAPORE 089316 | Clinical Innovations, LLC<br>747 West 4170 South,<br>Murray, UT 84123,<br>USA |
| Intended Use | The babyLance is an incision device to obtain a blood<br>sample from the heel of newborn and preemie<br>infants. The babyLance has a sharps prevention<br>feature to protect the user from a sharps injury. | Intended to be used by<br>trained healthcare<br>professionals to draw a blood<br>sample from the heel of a<br>neonate or infant. |
| Indications for Use | The babyLance is an incision device to obtain a blood<br>sample from the heel of newborn and preemie<br>infants. The babyLance has a sharps prevention<br>feature to protect the user from a sharps injury. | The babyLance safety<br>heelstick is a single-use<br>incision device to obtain a<br>blood sample from the heel of<br>a neonate or infant.<br>babyLance has a sharps<br>prevention feature to protect<br>the user from a needlestick<br>injury. |
| Product Code | FMK | Same |
| Panel | General & Plastic Surgery | Same |
| Classification | Class I | Class II |
| Regulation | 21 CFR 878.4400 | 21 CFR 878.4850 |
| Patient Population | Newborn, Premature Infants | Same |
| Principals of | The stainless-steel blade is deployed by removing the | Same |
| Operation | trigger lock and pressing a spring-loaded trigger. The<br>principals involved in the operation of this device are<br>all principles of mechanical energy. | |
| Labeling | Individual Tyvek label, Secondary box label, Tertiary<br>shipping box Label. | Same. See Section 13 for<br>device labeling. |
| Design | ABS housing containing stainless steel blade activated<br>by a trigger. Blade retracts into housing after incision<br>is made. | Same |
| Mechanical Specifications | | |
| Overall Size | Length: 1.25 in (3.2 cm)<br>Height; 1.25 in (3.2 cm) | Same |
| Cut Profile "Micro<br>Preemie" | N/A | Length: 2.2 mm<br>Depth: 0.60 mm |
| Cut Profile "Preemie" | Length: 2.89 mm<br>Depth: 0.86 mm | Length: 3.0 mm<br>Depth: 0.85 mm |
| Cut Profile<br>"Newborn" | Length: 3.01 mm<br>Depth: 1.08 mm | Length: 3.0 mm<br>Depth: 1.00 mm |
| Material Composition | | |
| Blade (blood contact) | 304 Stainless Steel | Same |
| Housing/Case (heel<br>contact) | High Density Polyethylene (HDPE) | Same |
| Trigger (no patient<br>contact) | Acrylonitrile Butadiene Styrene (ABS) | Same |
| 21 CFRLatex content | Latex Free | Same |
| Chemical<br>Composition | N/A | N/A |
| Energy Source | N/A | N/A |
| Safety Features | | |
| Sharps Injury<br>Prevention Passive<br>Feature | 1. Remove trigger lock<br>2. Blade exits the housing only during use,<br>spring driven, activated by trigger.<br>3. Lancet will automatically retract at the end<br>of incision motion. | Same |
| Prevention of Tip<br>Exposure | Blade is not exposed except when device is used<br>against the infant's heel. | Same |
| Automatic Lancet<br>Retraction After Use | When device is used, the end of the incision motion<br>retracts and locks the blade back into the housing. | Same |
| Prevention of Lancet<br>Reuse | The blade retracts back into the housing at the end of<br>the incision motion; the internal locking mechanism<br>locks the blade in the housing. | Same |
| Use Condition<br>Provided | Sterile, Single Patient Use | Same |
| Sterilization Method | Gamma Irradiation | Same |
| SAL | 10-6 | Same |
| Shelf-life | 4 Years | Same |
| Biocompatibility<br>Profile | "External Communicating Device" with<br>Tissue/Bone/Dentin contact with limited patient<br>exposure (<24 hour) | Same |
| Biocompatibility<br>(ISO 10993-1) | Cytotoxicity - not cytotoxic<br>Sensitization – no evidence of causing sensitization<br>Irritation – no evidence of causing irritation | |
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Image /page/5/Picture/0 description: The image shows the logo for Clinical Innovations. The logo features a stylized, abstract shape in shades of gray and green, resembling interconnected segments. To the right of the shape, the words "CLINICAL INNOVATIONS" are written in a simple, sans-serif font, with "CLINICAL" in a lighter gray and "INNOVATIONS" in a darker gray. Below the company name is the tagline "forMOM. forBABY. forLIFE." in a smaller, lighter font.
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Image /page/6/Picture/0 description: The image shows the logo for Clinical Innovations. The logo features a circular design with three overlapping shapes in gray and green. To the right of the circular design, the words "CLINICAL INNOVATIONS" are written in gray. Below that, the words "forMOM. forBABY. forLIFE." are written in a smaller font.
### Biocompatibility
According to ISO 10993-1:2018 Biocompatibility compliance assessment, the device was assessed to be "External Communicating Device" with Tissue/Bone/Dentin contact with limited patient exposure (<24 hour).
Biocompatibility testing has been performed on finished product materials, which are in contact with the human body, in accordance with ISO 10993 Part 1: Biological Evaluation of Medical Device. The results of this pre-clinical testing indicate that the materials met the test requirements as specified and that based on the results of the testing performed, the device is considered appropriate from a biological and toxicological perspective for its intended use in all patient populations.
#### Physical Characterization
babyLance Safety Heelstick Device has completed the applicable physical characterization and verification. This testing included: Biocompatibility, Shelf-Life, Shipping, Usability, Simulated Use and User Validation.
#### Substantial Equivalence
The babyLance Safety Heelstick device has the same principles of operation, intended use, and technological characteristics as the predicate device. The minor differences do not raise any issues of safety or effectiveness. Testing results support the determination of substantial equivalence with the results demonstrating that the babyLance Safety Heelstick has equivalent results as the predicate device.
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7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
