INDUSTRY NEWS

Critical Need for Pediatric Electrophysiology Devices is Focus of Medical Device Competition

Congenital heart disease (CHD) affects six out of 1,000 babies born in the U.S. each year and is often complicated by arrhythmias. While the last decade brought great advances in technologies that improve the care of adult arrhythmias, pediatric patients have been left behind, with only five devices approved for use in children in the same period.

CMS Facing Pressure to Add Telehealth to Diabetes Prevention Programs

The Alliance for Connected Care is leading a new lobbying effort to have telehealth included in the Medicare Diabetes Prevention Program, both during and after the COVID-19 public health emergency.

As the FDA Clears a Flood of AI Tools, Missing Data Raise Troubling Questions On Safety and Fairness

Artificial intelligence is the fastest-growing frontier in medicine, but it is also among the most lawless. U.S. regulators have approved more than 160 medical AI products in recent years based on widely divergent amounts of clinical data and without requiring manufacturers to publicly document testing on patients of different genders, races, and geographies, a STAT investigation has found.

ADDITIONAL UPDATES

FDA Grants Breakthrough Device Designation to AI-Powered ECG Analysis Tool

The platform, developed as part of a collaboration with Geisinger, uses 12-lead ECG data to predict a patient’s future risk of atrial fibrillation (AFib) and atrial flutter. Tempus hopes these insights can help clinicians identify, diagnose and treat heart rhythm issues.

New Legislation With Bipartisan Support Would Improve Patient Access to Cardiac, Pulmonary Rehab Programs

New legislation has been introduced in the U.S. House of Representatives that, if signed into law, would improve patient access to critical cardiac and pulmonary rehabilitation (CR/PR) programs under Medicare. The Increasing Access to Quality Cardiac Rehabilitation Care Act of 2021 (HR 1956) was introduced by Rep. Lisa Blunt Rochester, a Democrat out of Delaware, and Rep. Adrian Smith, a Republican out of Nebraska.

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