Latest News

30 April

FDA issues final rule regulating LDTs as medical devices

Credit: Shutterstock/motorolka

The US Food and Drug Administration (FDA) has issued its Final Rule in officially making explicit that In Vitro diagnostic products (IVD), also known as laboratory-developed tests (LDT), are medical devices under the Federal Food, Drug, and Cosmetic Act. 

The FDA announced the final rule on 29 April, aimed at giving the body greater oversight into how LDTs are designed and validated for use amid concern that such tests are becoming increasingly frequent across a number of indications and facilities. 

The FDA has now issued a policy confirming that over the course of the next four years, it will phase out its current discretionary approach towards LDTs, issuing targeted enforcement discretion policies for certain categories of IVDs manufactured by laboratories. 

2 May

MHRA sets out principles for AI ahead of planned UK regulation

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has set out what it calls, a strategic approach, artificial intelligence (AI) in healthcare as the UK government considers plan to legislate and regulate the technology. 

The MHRA report, presented to the UK government, sets out the call for regulation in the AI heathtech space as well as calling on the UK government to find international alignment when it comes to constraining the tech or else risk losing out. At the same time the paper suggests that many Class I devices using AI, able to be on the market without authorisation, could be bumped up to Class II. 

The MHRA says that when it comes to use the use of AI as a medical devices there needs to be a strong focus on the use of cybersecurity features with plans to publish another advisory paper on the subject in 2025. 

30 April

FDA approves Labcorp companion diagnostic for Pfizer gene therapy

The US Food and Drug Administration (FDA) has approved Labcorp’s nAbCyte Anti-AAVRh74var HB-FE assay as a companion diagnostic to Pfizer’s Beqvez (fidanacogene elaparvovec-dzkt). 

The assay will determine the patient’s eligibility to receive Pfizer’s FDA-approved haemophilia B gene therapy. Beqvez was approved to treat moderate to severe haemophilia B, a rare genetic disorder characterised by insufficient blood clotting due to a deficiency in factor IX (FIX), leading to prolonged and more frequent bleeding. 

Labcorp’s nAbCyte cell-based neutralising antibody assay detects the presence of pre-existing neutralising antibodies (nAbs), which can interfere with the gene therapy’s adeno-associated virus delivery vector and decrease the efficacy of the treatment. 

29 April

Philips shares rally following $1.1bn settlement for sleep apnoea lawsuits

Philips has reached a settlement in the US covering lawsuits relating to its faulty sleep apnoea devices, ending a long-lasting legal battle.  

The company has agreed to pay $1.1bn to settle the personal injury claims and medical monitoring class action lawsuit. The payments are expected in 2025 and will come from Philips’ cash flow. 

Whilst Philips said the agreement with plaintiffs’ leadership ends “uncertainty associated with the litigation”, the company did not admit fault nor liability. Shares in the Dutch medtech giant surged 25% at market open following the settlement which was lower than expected from analysts across the industry. Bloomberg analysts had predicted a payment range between $2bn and $4.5bn. 

22 April

Johnson & Johnson launches two new devices in EMEA

Medical device giant Johnson & Johnson (J&J) has launched two new products in Europe, the Middle East and Africa – the Ethizia haemostatic sealing patch, and the Cereglide aspiration catheter.  

Ethizia, a pad designed to control bleeding on internal organs except neurological and cardiovascular, gained CE mark approval in November 2023. The patch, developed by J&J medtech company Ethicon, features synthetic polymer technology, and claims to be the first and only haemostatic matrix that is equally productive and active on both sides.  

The haemostatic sealing patch stopped bleeding in 30 seconds in 80% of the patients who were examined in a clinical trial. It stopped bleeding six times faster than the leading Fibrin sealing patch, according to J&J in the 18 April announcement.