Policy & Regulation
Regulation
The MHRA’s post-market surveillance regulations for Great Britain will be followed in 2026 by a pre-market regulation, but its progress will not be steered by the agency’s erstwhile leader of device system transformation. The ABHI’s Steve Lee and Phil Brown ponder where national device system regulation – and the MHRA – go next.
The new definition of what is considered an ‘AI system’ in the context of the EU’s AI Act is helpful, but there is no automatic determination for medtech, and gray areas persist.
The European Commission has launched a pilot to deliver on its promise that member states should coordinate with each other on clinical assessment reviews under the Medical Device and IVD Regulations.
The US Food and Drug Administration (FDA) draft guidance limits tissue biopsy collection in clinical trials to primary endpoints and specific research use cases. However, Andrew Newland, CEO of circulating tumor cell (CTC) liquid biopsy firm Angle Plc, believes that the guidance could enhance the market for liquid biopsy makers.
Compliance
The FDA's recent communication freeze has blocked participation in international standards development groups. The agency's absence could impact the alignment of US and international standards, potentially affecting medical device manufacturers' ability to sell products globally.
The US FDA says diabetes patients who rely on their smartphones to receive critical disease-related alerts should ensure their phones are configured correctly. If not, the alerts might be missed.
Agencies within the US Department of Health and Human Services are beginning to communicate with the public again as HHS lifts the pause for some types of notices. However, other delays persist.
Several pages on the US FDA website related to diversity and inclusion are down, which aligns with Trump’s recent executive order on diversity, equity, and inclusion. However, the Department of Health says there's been a “short pause” in communications to allow the incoming team to get in place.
Recalls
While communications from the FDA have been scant since the presidential transition, early alerts from the agency’s device center are flowing again. The most recent alert includes an issue with numerous injuries and four deaths associated with a device used during cardiac procedures.
A failure to properly route cardiac events has led Philips to recall its heart monitoring software that interprets ECG data. Multiple injuries and two deaths are associated with the problem.
The Therapeutic Goods Administration is advising companies to get up to speed with its new recall procedure, which is designed to improve the timeliness of recalls, alerts and corrections, and reduce regulatory burden for sponsors.
The US FDA has labeled Hologic’s BioZorb Markers recall as Class I high-risk, highlighting safety concerns about devices cleared via the 510(k) pathway. The recall is due to reports of adverse events tied to the radiographic markers.
Approvals
Inflammatix received US FDA clearance to market its TriVerity Test System to help emergency departments quickly triage patients suspected of having acute infection or sepsis. Medtech Insight spoke with Inflammatix CEO Tim Sweeney about the company’s business strategy and marketing plans.
"Medtronic's device is the only DBS with adaptive capability," Amaza Reitmeier, vice president and general manager of Brain Modulation at Medtronic, told Medtech Insight. Two new BrainSense features work together to provide personalized brain stimulation for patients with Parkinson's disease.
After raising $68m series B funding in September, Neo Medical's announced on 2 December that its entire product portfolio has secured EU MDR approval. Co-CEO and founder Vincent Lefauconnier explained the rationale to Medtech Insight.
The US Senate is considering a bill to expand Medicare coverage for breakthrough devices and diagnostics, removing the five-per-year limit imposed by CMS’ Transitional Coverage for Emerging Technology (TCET).
Legislation
The director of the US FDA’s device center is sounding the alarm on the scarcity of critical devices for pediatric patients and says the agency is focused on solutions to this “unique” challenge.
The US FDA has finalized guidance on notifying the agency of potential device shortages during or prior to a public health emergency. The document includes a list of devices that manufacturers must notify the FDA of when they are in short supply. The guidance also clarifies that device makers voluntarily notify the agency of potential supply chain disruptions at any time.
The medtech industry played a pivotal role in the first Trump administration, most notably during the COVID-19 pandemic. But the sector was also impacted by the administration’s deregulation push and trade posture towards China, including tariffs. So, should stakeholders expect more of the same in a second Trump term, or brace for uncertainty and change?
A US House Oversight Committee report criticizes the government's COVID-19 response, including PPE shortages and issues with the CDC’s test development process. However, it praises the successful public-private partnerships in developing diagnostics, emphasizing the importance of leveraging private industry expertise for future pandemic preparedness.
Legal & IP
Attorneys with law firm Gibson Dunn believe that fewer investors will be investigated for False Claims Act violations under the incoming Trump administration but expect other policy to go full steam ahead.
Despite questions surrounding the SEC rule, including disputes being litigated in the US Eighth Circuit, companies must prepare to meet the new climate disclosure requirements in addition to related mandates in California and abroad. Experts emphasize opportunities beyond compliance.
As the 6 May deadline to implement the FDA’s final rule on lab-developed tests approaches, attempts to stop the rule from taking effect are set to play out in court. A panel of experts discussed the potential impact of these legal efforts, should they be successful, at the Medtech Conference in Toronto.
The College of American Pathologists wants a US district court to scrap the FDA’s final rule that unilaterally assumes oversight of lab-developed tests, but not because the college feels the agency has no business regulating them. Helena Duncan, senior director of quality at CAP, explained the college’s position to Medtech Insight.