Latest News

22 February

FDA warns of fraudulent data coming from third party labs

Credit: Shutterstock / Jeppe Gustafsson

The US Food and Drug Administration (FDA) is warning medical device manufacturers and sponsors to watch out for fraudulent or unreliable data produced by third-party laboratories after recording an uptick in fabricated or duplicated data in submissions. 

On Feb. 20, the US agency warned device manufacturers and sponsors to ensure they double-check the results provided by some third-party test labs after discovering that some of these labs are generating data that is either fabricated or in some cases pulled from other device submissions to the FDA. 

Whilst no one laboratory or submission to the FDA is cited, the body noted that many of the submissions containing fraudulent data contain data provided by third-party test labs based out of China or India. 

20 February

Medtronic exits “unprofitable” ventilator market

Medtronic has called it quits on the ventilator market, citing “increasingly unprofitable” product lines. 

The medical device giant is the market leader for ventilator devices in the US and Europe, occupying a 42.5% and 18.4% market share in the two regions respectively, according to a report by GlobalData. 

As a result of the move, the remaining businesses in the company’s Patient Monitoring and Respiratory Interventions (PMRI) unit will combine to form a new Acute Care and Monitoring (ACM) business. 

Medtronic had originally planned to operate its PMRI business as a separate company after announcing plans of a spin-off in October 2022. Fellow medtech giants, including GE HealthCare, were touted as potential buyers, according to Reuters. 

Medtronic did not disclose further details as to why it pulled the plug on its ventilator line, providing no reasons as to why its market position is no longer financially viable. It is no secret that sales of the company’s ventilators have slowed since the soaring demand experienced during the Covid-19 pandemic. 

22 February

Do not use smartwatches to measure glucose levels, FDA says

No, smartwatches cannot directly measure glucose levels. The US Food and Drug Administration (FDA) says to avoid devices that claim to do this, warning of the possible health risks. 

Despite an ample supply of smartwatches and smart rings being sold through online marketplaces that claim to directly measure blood glucose, the FDA says it has not reviewed any such device. 

“The FDA has not authorised, cleared, or approved any smartwatch or smart ring that is intended to measure or estimate blood glucose values on its own,” the agency said in a safety communication aimed at consumers, patients, and health care providers. The erroneous claims by manufacturers are especially dangerous to those living with diabetes.

Inaccurate blood glucose measurements can lead to incorrect doses of insulin or other medications used to manage the disease. Dangerously high doses of insulin can even lead to death. The agency was keen to differentiate approved products that use sensors to pierce the skin. Continuous glucose monitors (CGMs) such as Abbott’s Freestyle Libre and DexCom’s G6 are regulated by the FDA and reliably measure blood sugar levels.

6 February

Dexcom launches real-time CGM solution Dexcom ONE+ in Europe

DexCom launched its real-time continuous glucose monitoring (CGM) system Dexcom ONE+ in Spain, Belgium, and Poland. 

The company also revealed that the device will launch in the Netherlands in the week starting 12 February. Dexcom said it will launch Dexcom ONE+ in the Middle East, Africa, and other European countries in the coming months. 

The Dexcom ONE+ system consists of a water-resistant sensor to measure blood glucose, a transmitter that sends CGM readings and a Dexcom One smartphone-compatible app. The system allows for real-time monitoring of blood glucose by both the user and up to ten additional people to allow for shared monitoring. 

19 February

New UK medical device industry body Team-AB officially launches

A new UK industry body designed to help medical device regulators navigate the new legal landscape of a post-Brexit Britain has launched with backing from 11 companies. 

The UK Association for Medical Device Approved Bodies, known as Team-AB, was initially formed at the end of 2023, with the industry body announcing its official launch on 19 February 2024. The group said that its aim is to represent medical device companies in dealings with stakeholder groups such as the Medicines and Healthcare Products Regulatory Agency (MHRA) and industry trade associations. 

The new body launched with backing from 11 medical device certification bodies ranging from BSI Assurance to the UK arms of German equipment testing companies, TUV Rheinland and TÜV SÜD.