Latest News

Credit: Shutterstock/Postmodern Studio

Laboratory Developed Tests (LDT) are set to be regulated as medical devices under new rules proposed by the US Food and Drug Administration. 

The proposed rule seeks to amend the FDA’s regulations to make explicit that In Vitro Diagnostic Products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act. This is when the manufacturer of the IVD is a laboratory. 

The FDA is also proposing a new policy under which it intends to provide greater oversight of LDTs, through a phaseout of its general enforcement discretion approach. However, the FDA has said this rule will not apply to all LDTs currently on the market. 

The organisation argued that since the Medical Device Amendments of 1976 ruling was passed, which set the initial rules for how LDTs are treated, LDTs have become more complex, can be run in large volumes for varying amounts of patients and are used for frequently for guiding healthcare decisions. 

Multinational electronics and medical device manufacturer Philips knew for over a decade about the defects in its respiratory devices before issuing a recall in 2021, it has been reported. 

According to a ProPublica and Pittsburgh Post-Gazette joint investigation, the company’s respirator subsidiary, Respironics, altered the design of its ventilators and sleep apnoea machines in 2010, packing them with polyester-based polyurethanesame, a foam used in sofas and mattresses, to prevent a persistent rattling. This decision was taken despite journal articles indicating that the foam in question broke down under heat and humidity. 

Soon after the change, however, the company is said to have begun receiving reports of contaminants within the devices, describing “black particles”, “dirt and dust” and an “oily-like substance”.

Rather than fulfil its legal duty to send these reports to the US Food and Drug Administration (FDA), Philips reportedly kept them to itself. ProPublica indicates that, over the next 11 years, thousands more reports would be concealed and millions more machines sold. 

Yamaha Motors is adding patients to its motorcycle-heavy clientele, as the Japanese mobility giant rides into healthcare with the launch of Tuning Fork Bio – an antibody analysis company. 

Tuning Fork Bio, which is based in Delaware, US, will partner with the Translational Research Centre at Fukushima Medical University (FMU TR) in Japan.  

Yamaha Motors stated that the antibody profiling service will help select suitable drugs for patients and aid in wider drug research. 

The research centre in Fukushima has developed technology that transfers proteins onto glass slides at high densities. The resulting diverse protein microarrays can be used to search for specific antibodies a patient has in their blood. According to Yamaha Motors, the centre has prepared more than 20,000 protein samples and includes viral and bacterial antigens, in addition to proteins from humans. 

Tuning Fork Bio, which has $10m capital, will utilise bioinformatics technology to analyse the microarray data. Applications include selection of antibodies suitable for indicators such as biomarkers or managing health conditions. 

A Saudi hospital has performed the world’s first-ever fully robotic liver transplant on a patient suffering from non-alcoholic liver cirrhosis, in a move to ditch hybrid techniques. 

The Riyadh-based King Faisal Specialist Hospital & Research Centre carried out the procedure on a 66-year-old patient who additionally suffered from hepatocellular carcinoma, carried out by the hospital’s Organ Transplant Center of Excellence (OTCE). 

The surgery was carried out without the use of a hybrid approach, meaning that the surgery was performed entirely using a ‘state-of-the-art’ robot.

 The OTCE claims that its specialisation lies in performing surgeries that rely on smaller more precise incisions, which it argues is more reliable in preventing complications and allowing patients to be successfully discharged more often. 

The recipient of the liver was successfully discharged following the procedure. 

Dr Dieter Broering, executive director of the OTCE, said: “With this remarkable feat, we at KFSH&RC reaffirm our commitment to pushing the boundaries of medical innovation and enhancing the quality of healthcare services offered to patients worldwide.” 

Surgeons in the US have used Moon Surgical’s Maestro system to aid weight loss surgery procedures, in what are the first-use cases of the robotic system in the country. 

Maestro, which received US Food and Drug Administration (FDA) clearance in December 2022, is designed to assist in traditional laparoscopic procedures. 

Three surgeons at Baptist Health in Florida, US, used the robotic system to help perform sleeve gastrectomies – the most common weight loss surgery. The robotic arms can hold and adjust instruments, reducing the number of staff required in the operating room.

Dr Ron Landmann, chief of colon and rectal surgery and medical director of informatics at Baptist Health said in a statement: “Maestro provides the control and dependability needed in minimally invasive surgery at a time when staffing shortages introduce workflow challenges and variability.”