SPOTLIGHT -
Senior leaders focused on the advancement of digital medicine and health meet to discuss the importance of these tools for life sciences stakeholders
Implicity Appoints Jon Hunt, PhD, As Chief Commercial Officer
Hunt joins the company from HeartBeam.
FDA Releases Draft Guidance for Regulatory Considerations for Prescription Drug-Use-Related Software
The agency differentiates between software that has a notable impact on the effectiveness and safety of drug use.
FDA Approves AI Sleep Disorder Diagnosis Software
Korean-based company HoneyNaps developed the algorithm.
908 Devices Launches Real-Time Monitoring Platform For Multiple Bioprocess Parameters
The device, Maverick, utilizes Raman spectroscopy for bioprocess control.
IceCure Medical’s ProSense System Does Not Receive Clearance for Breast Cancer
The decision will not impact the device’s FDA clearance for other indications.
FDA Grants IDE Approval to Study of CereVasc’s eShunt System
The system will be part of a NPH study.
VUNO Reveals Prospective Study Results for AI-Based Cardiac Arrest Risk Management System
The results are published in "Critical Care," an international journal focused on intensive care medicine.
FDA Approves Beacon Biosignals’ AI-Assisted Sleep Monitoring Device
Dreem 3S to implement electroencephalogram data from the brain to monitor sleep architecture.
Wellysis’ Wearable Electrocardiology Patch Receives FDA Approval
S-Patch Ex designed to record heart rate both at home and in a clinical setting.
Awak Technologies Raises $20M in Series B Funding
Proceeds expected to help company drive several initiatives, including enhancements to its ultraportable peritoneal dialysis system.
Precision GI Endoscopic Biopsy Device Receives 510(k) Clearance From FDA
Limaca Medical’s device had previously received a breakthrough device designation from FDA.
OnPoint Surgical Announces 510(k) Clearance from FDA For Augmented Reality Spine System
The device used a headset with a virtual display to provide information to surgeons during procedures.
FDA Clears Zeta Surgical’s Mixed Reality Navigation System
The device provides surgeons with GPS-like guidance.
FDA Grants Breakthrough Designation to Admetsys’ Automated Glucose and Continuous Blood Diagnostics System
This will allow the product to arrive in hospitals at a faster pace.
Economic Downturn Can Still Spell Success for Medical Devices
Opportunity still exists despite market conditions.
Brazil Grants Regulatory Approval to ProSense Cryoablation System
The technology, created by IceCure Medical, freezes tumors and is an alternative to surgical intervention.
Augmented Reality Platform To Be Presented At 2023 Wells Fargo Healthcare Conference
OnPoint, a group of privately held AR companies, will present the platform.
Q&A With EVERSANA Leaders on Bringing a Medical Information Chatbot to Life
Abid Rahman and Mike DeLuca discuss developing the AI-powered chatbot.
FDA Grants Class II Device Exemption For BionicM’s Bio Leg
The device is described as a motor-robotic prosthetic knee.
Q&A With Simon Arkell, Co-Founder and CEO of Synthetica Bio
Arkell discusses the need to democratize AI for the healthcare industry.
Q&A With Mike Monovoukas, CEO and co-founder of AcuityMD, and Arjun Ishwar Of Miach Orthopedics
AcuityMD’s CEO speaks about the current market and how its impacting smaller medical device companies.
XtalPi Inc. Announces New Intelligent Automation Brand
The company also announced a new automation facility to be located in Shanghai.
FDA Grants Clearance to Versi HD With GuideMe Software
The FDA granted 501(k) clearance to Fresenius’ Versi HD with GUideMe Software. The device will be available in select markets at some point in 2023, and previous models will be upgradeable.
Q&A With John McDonough, Executive Chair and CEO of Sunbird Bio
The CEO spoke about recent mergers and testing for Alzheimer’s.
New Study Says 4D Medical Animation Will Lead Global Animation Market In Coming Years
Research and Market’s report also says that the medical animation market will grow by a CGAR of 19.9% in the next decade.
FDA Grants Clearance To Levita Magnetics’ Surgery Platform
The MARS platform combines magnets and machinery.
FDA Designates NyokAssist As A Breakthrough Device
The device, developed by magAssist, is an interventional ventricular assistance device.
Veta Health Announces New Partnerships
The virtual health and remote care company is partnering with BioIntelliSense and Stel Life.
Revolutionizing ICU Care: Advancing Nutritional Technology Through Clinical Trials
Art Medical’s CEO Liron Elia explains the importance of enteral nutrition in ICU patient care.
China’s Wearable Medical Device Market Expected to See Significant Growth
A new report details the factors expected to drive the market’s growth in the coming years.