DEVICE AUTHORIZATIONS: TALON SPACER for avascular necrosis, GILI biosensor for touchless heart and respiratory rates, GI GENIUS for colonic mucosal lesions, IPSIHAND for stroke rehabilitation

Patient Specific Talus Spacer

 Additive Orthopaedics

INDICATION FOR USE: For avascular necrosis of the ankle joint. The anatomical landmarks necessary for the design and creation of the Additive Orthopaedics Patient Specific Talus Spacer must be present and identifiable on computed tomography scan.

ADDRESSING UNMET NEED: Avascular necrosis is a rare, serious and potentially debilitating that can cause removal of part of leg; provides patients with treatment option that could potentially reduce pain, retain range of motion of joint and improve quality of life

DECRIPTION: Additively manufactured implant made from cobalt chromium metal alloy and produced by laser sintering

  • Made for each patient individually, modeled from computed tomography (CT) imaging, and is fitted to a patient’s specific anatomy
  • During replacement surgery, patient’s talus bone is removed and replaced with implant made from cobalt chromium alloy
  • Intended to be a joint-sparing procedure, as it allows the patient to retain motion in the ankle joint


  • Results from 31 patients and 32 talus replacement surgeries (one patient had operations on both ankles) with the implant
  • Probable benefit endpoint: Reduction in baseline level pain following surgery using the Visual Analog Scale (“VAS”) + ankle range of motion (“ROM”), Foot and Ankle Outcome Scores (“FAOS”) and FAOS subscales on activities of daily living (“ADL”), ability to perform sports and recreational activities, QoL
  • Primary safety endpoint: Secondary subsequent surgical intervention (“SSSI”) + adverse events
  • At three years post-operation, the average reported pain decreased from “moderate to severe” prior to surgery to “mild” post-surgery, and average range of motion in the ankle joint also improved
  • By the three-year mark, 3 reported additional surgeries
  • The most common reported adverse events were pain and scar tissue at the surgery site

REGULATORY PATHWAY: Humanitarian Device Exemption

  • Trade/Device Name: Patient Specific Talus Spacer
  • Product Code: QNN
  • Annual Report requirements
  • Post-approval study: Patient Specific Talus Spacer Registry PAS is a prospective post-approval US registry study to provide ongoing safety and probable benefit assessment


Gili Pro BioSensor

ContinUse Biometrics Ltd.

INDICATION FOR USE: Includes an optical module that is intended to capture motion-vibration signals from an illuminated surface for assessment of physiological information. Such information, captured during spot-measurement, includes: Heart rate, Respiratory rate

The device is indicated for use by or under the supervision of healthcare professionals for adult patients in a hospital, outpatient, or other medical care settings, or for clinical research purposes. The device should be used while the subject is seated upright either in a chair or in a bed. The information stored on the system may be reviewed by qualified persons.

DEVICE TYPE: Hardware and software for optical camera-based measurement of pulse rate, heart rate, breathing rate, and/or respiratory rate.

  • The device uses an optical sensor system and software algorithms to obtain and analyze video signal and estimate pulse rate, heart rate, respiratory rate and/or breathing rates.
  • Not intended to independently direct therapy


  • Representative of the intended use population for the device
  • Demonstrate output consistency using the expected range of data sources and data quality encountered in the intended use population and environment
  • Compare device output with a clinically accurate patient-contacting relevant comparator device in an accurate and reproducible manner


  • Delayed or incorrect treatment due to erroneous output as a result of device malfunction or algorithm error
  • Delayed or incorrect treatment due to user misinterpretation
  • Eye damage, burns, and related safety concerns due to illuminating optics


  • Regulation Number: 21 CFR 870.2790
  • Regulation Name: Hardware and software for optical camera-based measurement of pulse rate, heart rate, breathing rate, and/or respiratory rate
  • Regulatory Class: Class II
  • Product Code: QOK


GI Genius

Cosmo Artificial Intelligence – AI, LTD /Medtronic

INDICATION FOR USE: Computer-assisted reading tool designed to aid endoscopists in detecting colonic mucosal lesions (such as polyps and adenomas) in real time during standard white -light endoscopy examinations of patients undergoing screening and surveillance endoscopic mucosal evaluations. The GI Genius computer-assisted detection device is limited for use with standard whitelight endoscopy imaging only. This device is not intended to replace clinical decision making.

DEVICE TYPE: Gastrointestinal lesion software detection system

  • Computer-assisted detection device used in conjunction with endoscopy for the detection of abnormal lesions in the gastrointestinal tract. This device with advanced software algorithms brings attention to images to aid in the detection of lesions. The device may contain hardware to support interfacing with an endoscope


  •  Demonstrate that device performs as intended under anticipated conditions of use, including detection of gastrointestinal lesions and evaluation of all adverse events


  • Algorithm failure leading to – False positives resulting in unnecessary patient treatment; or False negatives resulting in delayed patient treatment
  • Failure to identify lesions, resulting in delayed patient treatment, due to software/hardware failure including: Incompatibility with hardware and/or data source, Inadequate mapping of software architecture, Degradation of image quality, Prolonged delay of real-time endoscopic video


  • Regulation Number: 21 CFR 876.1520
  • Regulation Name: Gastrointestinal lesion software detection system
  • Regulatory Class: II
  • Product Code: QNP


IpsiHand Upper Extremity Rehabilitation System

Neurolutions Inc

INDICATION FOR USE: For use in chronic stroke patients (≥ 6 months post-stroke) age 18 or older undergoing stroke rehabilitation, to facilitate muscle re-education and for maintaining or increasing range of motion in the upper extremity.

DEVICE TYPE: Electroencephalography (EEG)-driven upper extremity powered exerciser

  • An EEG-driven upper extremity powered exerciser is a non-invasive prescription device intended for rehabilitation by driving movement or exercise of an impaired upper extremity in response to the detection of purpose oriented electrical activity produced by the patient’s brain


  • Unblinded study of 40 patients over a 12-week trial
  • All participants demonstrated motor function improvement with the device over the trial
  • Adverse events reported included minor fatigue and discomfort and temporary skin redness 


  • Device provides ineffective treatment, leading to worsening condition
  • Unintended motion leading to injury
  • Thermal injury including burns and shock
  • Adverse tissue reaction
  • Cross contamination, leading to infection or adverse tissue reaction
  • Pain or discomfort including: Headache, Fatigue, Skin redness

REGULATORY PATHWAY: De Novo request, Breakthrough designation

  • Regulation Number: 21 CFR 890.5420
  • Regulation Name: Electroencephalography (EEG)-driven upper extremity powered exerciser
  • Regulatory Class: Class II
  • Product Code: QOL


Image credit: Respective device manufacturers

News and Views: Janssen COVID vaccine pause lifted, Guidance for developing COVID drugs, New pharmacometrics approach, Standards to ban menthol cigarettes, CDRH patient science, Opioid safe disposal, Colorectal cancer screening

FDA and CDC Lift Recommended Pause on Janssen Vaccine Use Following Thorough Safety Review

Based on confidence in vaccine’s safety and effectiveness following data assessment

  • Vaccine’s known and potential benefits outweigh its known and potential risks in individuals 18 years of age and older
  • Chance of clots is very low, but the FDA and CDC will remain vigilant in continuing to investigate this risk
  • Fact Sheet for Recipients and Caregivers, provide information on risk


COVID-19: Developing Drugs and Biological
Products for Treatment or Prevention

Guidance describes current recommendations regarding phase 2 and phase 3 trials for drugs under development to treat or prevent COVID-19

  • Population
  • Trial Design and Conduct
  • Efficacy Endpoints
  • Safety Considerations
  • Statistical Considerations


A New Approach to Pharmacometrics: Recurrent Neural Networks for Modeling Drug Exposure and Drug Response

Pharmacometric models based on recurrent neural network to simulate the time course of pharmacodynamic (PD) response that develops latently, according to complex biological intermediate step

  • A long short-term memory recurrent neural network (LSTM RNN) trained to use time sequence of simulated plasma concentrations along with patient baseline PD values and patient demographics to predict PD response in single dose regimen
  • Machine Learning model able to accurately predict the PD response of individuals who were treated with different dosing regimens
  • LSTM RNNs may complement traditional PK/PD models in the area of highly complex PK/PD data analysis and possibly facilitate development of predictive models with improved accuracy.  


Efforts to ban menthol cigarettes to reduce addiction and youth experimentation, improve quitting, and address health disparities

Two tobacco product standards within the next year to ban menthol as a characterizing flavor in cigarettes and ban all characterizing flavors (including menthol) in cigars

  • Menthol masks unpleasant flavors and harshness of tobacco products, more addictive and harder to quit
  • Banning menthol cigarettes would lead an additional 923,000 smokers to quit, including 230,000 African Americans, avert 633,000 deaths including about 237,000 for African Americans


CDRH Patient Science and Engagement

CDRH puts patients first with its Patient Science and Engagement Program

  • Communicating COVID-19 testing to underrepresented populations
  • Gender differences for heart failure Patient-Reported Outcome measure
  • Ranking factors influencing women’s decision making on uterine fibroids surgery decision making
  • Workshop of Patient-Generated Health Data and its use across the healthcare ecosystem and during medical device development, evaluation, and monitoring


Critical Importance of Safe Disposal of Opioids  

Unused or expired medicines in the home have long been a major safety concern and implicated in most some common and most severe cases of accidental ingestion by children

  • Removing prescription opioids once no longer medically necessary can prevent accidental exposure or intentional misuse
  • Access drug take back site, check if a drug is on the  “flush list
  • FDA exercises oversight on packaging and disposal of drugs that pose risks of abuse or overdose, such as opioid analgesics
  • Take advantage of the National Prescription Drug Take Back Day 

Where and How to Dispose

Colorectal Cancer Screening Options

The only way to find a polyp, precancerous growth, or colorectal cancer is to do a screening test or procedure

  • FDA authorized Colorectal Cancer Screening: Stool sample tests (at-home stool test) and Visual screening procedures (colonoscopy, Flexible Sigmoidoscopy, CT Colonography)
  • Some Minority Groups Are at Higher Risk: Black men and women as well as American Indian and Alaska Native people
  • Colorectal Cancer Rates Are Up Among Adults Under 50


Image credit: FDA, CDC