Hannah Daniel

This week, the US FDA sent a warning letter to maker of batteries for AEDs, AMCO; Virtual Incision successfully completed the first hysterectomy its miniaturized robotic-assisted surgery device MIRA; The DOJ finalized a rule that requires government-operated health care facilities to provide accessible equipment for people with disabilities; the FDA compiled its resources on reprocessed medical devices onto a new web page; and more.

The long-awaited TCET final notice doesn't address major concerns, medtech industry advocates say.

DHAC's members, which span across multiple disciplines in the digital health industry, will hold their inaugural meeting this November.

This week, Medtronic recalled a nerve monitoring system due to reports of false responses. The US FDA approved the first auto-injector for opioid-overdose, made by Purdue Pharma. The agency granted de novo authorization for Labcorp's PGDx elio plasma focus Dx used by labs for genetic profiling. As of 7 August, 950 AI/ML devices have been approved by the FDA. EKO Health teamed up with LSU to help detect arrhythmias and murmurs in student-athletes.

Avenda's chief operating officer Brit Berry-Pusey spoke to Medtech Insight about the company's CPT III code for its prostate cancer mapping AI and how regulatory bodies can align to support innovators.

Despite a March recall and a following update, Tandem's t:slim X2 application is still causing the battery-depleting defect.

The FDA designated class II special controls classifications for two diagnostics and force separation catheters.

Biosensors are a fundamental tool in research and have promising future applications in health care.

2024 Physics Nobel Prize Resources from AIP

Although quieter, continuous active sonar still interferes too much with killer whale communication.