Policy & Regulation

The FDA approved JenaValve’s Trilogy HeartValve for treating severe aortic regurgitation, marking it as the first TAVR device for this condition in the US. The approval, which followed promising clinical results, is significant for patients with limited options due to high surgical risks.

HeartBeam’s CEO says the strength of clinical data convinced the US FDA to reverse course and grant clearance to his company’s innovative ECG device, which he says can assess arrhythmias at home with hospital accuracy.

Recently published lists show that the US Food and Drug Administration had cleared almost 2,000 digital health tools by the end of 2025. Of these, well over half – 1,104 – were radiology devices incorporating AI. Find a full breakdown in these tables.

Real-world evidence (RWE) is increasingly significant in medical device submissions, with FDA guidance evolving to embrace RWE benchmarks. The National Evaluation System for Health Technology (NEST) partners with firms to streamline RWE use, enhancing regulatory processes.

In an effort to streamline AI rules for high-risk systems and improve competitiveness, two European Parliament committees agreed amendments to the EU AI Act that will allow medtech companies to avoid double certification with notified bodies. A plenary vote takes place in late March.

The Trump EPA wants to loosen restrictions the Biden administration placed on facilities that sterilize medical devices with ethylene oxide, arguing the rollbacks are necessary to ensure device accessibility and supply chain security. Opponents to the rollbacks say EtO is a danger to public health.

A new final guidance document from the US FDA lays out premarket considerations for devices intended to help treat obesity, including clinical trial design, labeling, and safety concerns. The guidance also calls for sponsors to consider patient perceptions in evaluating device effectiveness.

The FDA’s device center has received a second citizen petition relating to the NarxCare algorithm by Bamboo Health. Both petitions argue that NarxCare qualifies as a regulated clinical decision support product, but it is not clear whether the second petition will succeed where the first failed.

The US FDA has issued an early alert concerning Intuitive Surgical staplers used during various procedures with the da Vinci Surgical System. The company is instructing customers to stop using the devices.

A recent FDA report to Congress reflects ongoing safety issues with orthopedic and cardiac implants, as well as commodities such as syringes and PPE.

The US FDA has issued an early alert concerning Abiomed’s Impella purge cassettes, a critical heart pump component that delivers rinsing fluid to the Impella catheter.

Class I medical device recalls reached record-breaking levels in 2025, according Sedwick’s annual product safety report, with device failure the leading cause.

A major vendor is suing Medicare over new reimbursement policies for skin cancer radiotherapy, which they claim could harm patient access to treatment. The policy applies the same reimbursement level to different equipment types, leading to industry disagreements about whether it’s fit for purpose.

Two lawyers within EU legal chamber Axon Lawyers created a Green Team to cope with the rise in EU Green Deal and related environmental sustainability and compliance needs for medtechs. One of them, Jilles van der Hoek, explains why manufacturers should be getting a jump on future requirements.

In an effort to streamline AI rules for high-risk systems and improve competitiveness, two European Parliament committees agreed amendments to the EU AI Act that will allow medtech companies to avoid double certification with notified bodies. A plenary vote takes place in late March.

The US FDA has issued an early alert concerning Intuitive Surgical staplers used during various procedures with the da Vinci Surgical System. The company is instructing customers to stop using the devices.

A major vendor is suing Medicare over new reimbursement policies for skin cancer radiotherapy, which they claim could harm patient access to treatment. The policy applies the same reimbursement level to different equipment types, leading to industry disagreements about whether it’s fit for purpose.

ExThera Medical is facing legal trouble after two patients died following treatment with its blood filtration device. The company's former chief regulatory officer has pled guilty to failing to report adverse events, while ExThera signed a deferred prosecution alert and agreed to pay $6.45m.

AdvaMed welcomed the Supreme Court’s recent decision to strike down the Trump administration’s policy on imposing tariffs on US trade partners, though the trade group doesn’t see the tariff issue going away.

The US Supreme Court struck a blow to the Trump administration’s efforts to impose sweeping tariffs, ruling the president exceeded his authority. Limiting tariffs has been a priority for the medtech industry.