SPOTLIGHT -
FDA Clears Positrigo’s NeuroLF Brain PET System for the Diagnosis of Multiple Brain Disorders
Clearance of the NeuroLF Brain PET system marks Positrigo’s first device of its kind to be approved in the United States.
AI-Controlled Virtual Assistant Announced for Digital Health Network for Self-Funded Healthcare Plans
Empara’s virtual assistant is the latest attempt to use AI to simplify the user experience in the healthcare industry.
FDA Approves Cordis’ Vascular Closure Device for Cardiac Ablation Procedures
Approval of the Mynx Control Venous vascular closure device was based on results from the ReliaSeal trial, which demonstrated 100% procedural and device success in cardiac ablation procedures.
FDA Grants Premarket Approval to Endotronix’s Cordella Pulmonary Artery Sensor System to Support Patients with Heart Failure
Cordella is the first pulmonary artery pressure-guided platform indicated for home-based comprehensive heart failure patient management.
Aidoc AI Software Used to Reduce Missed Follow Up Appointments
The company announced updates to its software to focus on this issue.
FDA Clears Two Abbott Glucose Monitoring Systems
Both systems are over-the-counter products that provide continuous glucose monitoring.
Evolution Optiks Receives FDA 510(k) Clearance for LFR-260 as the First Light Field Powered Subjective Tele-Fractor
According to the manufacturer, the LFR-260 features advanced technology that allows patients to compare multiple prescriptions simultaneously, eliminating the need for traditional refraction methods.
BD Acquires Edwards Lifesciences Critical Care Product Group to Bolster Monitoring Technology
Becton, Dickinson, and Company will acquire Edwards Lifesciences’ Critical Care Product Group for $4.2 billion in cash to expand its own smart connected care solutions.
FDA Approves Roche’s HPV Self-Collection Solution, Allowing Patients to Gather Their Own Samples in a Healthcare Setting
Roche’s human papillomavirus solution is reportedly one of the first of its kind to be available in the United States.
FDA Approves Two of Scientia Vascular’s Neurovascular Catheters
The catheters approved by the FDA include the Plato 17, a DMSO-compatible microcatheter, and the Socrates 38, an aspiration catheter specifically designed for treating ischemic strokes.
FDA Approves Abbott’s Dissolving Stent System for Chronic Limb-Threatening Ischemia in Arteries Below the Knee
Treatment marks the first dissolving stent approved in the United States for treating chronic limb-threatening ischemia in arteries below the knee.
Expanse Ice Receives FDA 510(k) Clearance for ICE Aspiration System for Peripheral Arterial, Venous Systems
Technology designed to effectively address blood clots by combining capabilities of larger devices with smaller catheters.
Evergreen Theragnostics Raises $26M in Capital to Aid Commercialization Efforts for the Ga-68 DOTATOC Diagnostic Kit
Capital also expected to assist the advancement of Evergreen's radiopharmaceutical discovery pipeline into clinical trials.
Philips Respironics Finalizes Consent Decree Regarding Business Operations in the US with Department of Justice, FDA
Decree comes amid the FDA’s 2021 inspection of Philips’ Murrysville facility and the subsequent voluntary recall of its sleep and respiratory care devices.
FDA Approves Abbott’s i-STAT TBI Whole Blood Rapid Test to Assess Patients for Concussions at Bedside
The concussion test, which shows results after 15 minutes, can help evaluate patients up to 24 hours after injury, company says.
FDA Approves Evolut TAVR System, Medtronic’s Treatment for Symptomatic Severe Aortic Stenosis
Evolut FX+ transcatheter aortic valve replacement system design includes a larger coronary access window through a modified frame.
TNO Launches Peregrion, Aiming to Increase Market Presence of Accelerated Biomedical Mass Spectrometry Technology
Spinoff seeks to aid pharmaceutical companies in accelerating early clinical development programs.
Use of AI Screening Tool for Cancer Expands Globally
AI-powered radiology solutions can be used with both chest x-rays and breast cancer detection.
FDA Approves Dexcom's Stelo, First Over-the-Counter Continuous Glucose Monitor
The CGM system is for adults over the age of 18 years who do not use insulin, such as individuals with T2D who use oral medications, a US population of 25 million.
FDA and Workflow Services Detail First 100 Days of Data Collection Partnership
The agency teamed up with the software company to develop platforms and networks to collect de-identified data.
FDA Issues Cautionary Reminder to Medical Device Manufacturers Regarding Data Submitted from Third-Party Laboratories
Agency reports concerns amid an increase in submitted data that has been fabricated, duplicated, or unreliable from third-party laboratories.
FDA Advisory Committee Endorses Abbott's TriClip System
Device designed to address tricuspid regurgitation through a vein in the leg.
Synchron Advances Efforts to Develop Brain-Computer Interface
Synchron’s brain-computer interface device is being developed to allow patients with mobility challenges to operate certain technology with their mind.
DELFI Diagnostics Launches Assay That May Improve Monitoring of Cancer Treatment Response
DELFI-Tumor Fraction assay was developed to improve noninvasive assessment of tumor burden and monitoring of treatment efficacy and resistance in patients with advanced cancers.
Wearable Device for Osteopenia in Postmenopausal Women Granted FDA Clearance
Osteoboost is the first non-pharmacological therapy approved to treat low bone density in postmenopausal women.
Tumor-Treating Fields Therapy Plus Standard of Care Under FDA Evaluation for NSCLC
Tumor-treating fields therapy uses alternating electric fields of intermediate frequency and low intensity to disrupt processes critical in the survival of cancer cells.
Noninvasive Axon Therapy Device Granted FDA Clearance for Diabetic Neuropathy
Axon Therapy uses magnetic peripheral nerve stimulation to deliver a non-invasive treatment for chronic pain related to nerve damage caused by diabetes.
Outlook for Pharmacy Technology in 2024
Expanding the use of technology that automates certain tasks will allow healthcare providers to do more with less risk of compounding burnout.
FDA Accepts BLA for Novel Positron Emission Tomography Imaging Agent for Renal Cell Carcinoma
Biologics license application filed for 89Zr-DFO-girentuximab (TLX250-CDx; Zircaix), a PET imaging agent for clear cell renal cell carcinoma.
Top 5 MDT Stories of 2023
Highlights of the year’s biggest news.