Policy & Regulation

The US FDA has approved Flow Neuroscience’s at-home brain stimulation device for the treatment of depression, ending a frustrating wait for the Swedish firm.

Medtronic won FDA clearance for its Hugo surgical robot for urologic procedures, which Wiliam Blair analyst expects will draw interest from physicians. But he also says that Intuitive Surgical will remain the clear dominant player.

BrainsWay advanced its Deep TMS platform with an FDA labeling expansion for adolescent MDD and the launch of a 200-patient alcohol use disorder trial. The company posted strong Q3 growth and is pursuing new indications and at-home neuromodulation through its Neuralief investment.

Tandem Diabetes Care is positioning for growth in 2026 with the launch of its Mobi Tubeless pump following FDA clearance of its Android-compatible Mobi app while navigating multiple recalls during what CEO John Sheridan called a transformative year.

As requested by a pair of US senators, the GAO has published a report on how the FDA handles medical device recalls. The review found that the agency lacks the necessary staff and regulatory authority to process recalls safely and effectively.

During a webinar hosted by Sedgwick, a pair of regulatory experts discussed how medtech firms can optimize their engagement with the FDA, especially when it comes to communicating recalls and corrective actions.

The US FDA’s General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee convened Wednesday to discuss germicidal ultraviolet (GUV) devices as a mode of disinfection, a technology that has emerged since the COVID-19 pandemic.

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 50 documents have been posted on the tracker since its last update.

As requested by a pair of US senators, the GAO has published a report on how the FDA handles medical device recalls. The review found that the agency lacks the necessary staff and regulatory authority to process recalls safely and effectively.

During a webinar hosted by Sedgwick, a pair of regulatory experts discussed how medtech firms can optimize their engagement with the FDA, especially when it comes to communicating recalls and corrective actions.

The US FDA says Olympus has updated its instructions for a device used in many endoscopic procedures after reports of serious injuries. The class I recall follows the FDA blocking imports of other scoping devices from the Japanese firm earlier this year.

Tandem Diabetes Care is positioning for growth in 2026 with the launch of its Mobi Tubeless pump following FDA clearance of its Android-compatible Mobi app while navigating multiple recalls during what CEO John Sheridan called a transformative year.

Joint Singapore-UK plan underlines direction of travel for MHRA after its embracing of international reliance (IR). Australia’s TGA has also broken new ground by recognizing the UKCA mark.

Industry associations support the commission’s MDR/IVDR revision simplification objective and aim to increase Europe’s competitiveness, but MedTech Europe also sees further room for improvement.

As requested by a pair of US senators, the GAO has published a report on how the FDA handles medical device recalls. The review found that the agency lacks the necessary staff and regulatory authority to process recalls safely and effectively.

The just published proposed targeted revision of the Medical Device and IVD Regulations is a radical rethink of how the EU should regulate medical devices. The document is aimed at supporting industry and patients alike.

A California jury found in favor of device firm Masimo in a long-running legal battle against the tech giant. Apple has already announced plans to appeal.

Ceribell has filed patent-infringement claims against Natus alleging its BrainWatch EEG copies Ceribell’s headband and electrode innovations. Natus denies any intellectual property violations, saying the products serve different purposes.

Insurance firm UnitedHealth is facing allegations the company intentionally used an unreliable PAD screening method to increase its reimbursements under Medicare Advantage. Semler Scientific and Bard, which respectively made and manufactured the products in question, settled related cases for $37m.

Emma Mittelstaedt Burnham prosecuted antitrust violations in healthcare sector in her previous work at DoJ, including leading investigation into antitrust cartels in the generic pharmaceutical industry.

As requested by a pair of US senators, the GAO has published a report on how the FDA handles medical device recalls. The review found that the agency lacks the necessary staff and regulatory authority to process recalls safely and effectively.

Rapid advancements in neurotechnology intensify the need for clear regulations concerning neural data privacy. As these technologies evolve at unprecedented speeds, lawmakers, legal experts, and neuroethicists are increasingly focused on their societal impact.

A recent study demonstrates that certain types of blood-based tests that screen for multiple cancers at once have the potential to flip the script on cancer diagnoses, including some of the deadliest types.

But the Senate’s reduction would not be as much as the House of Representatives and President Trump proposed earlier this year, which is likely a win for the agency.