Approvals

This week, Philips Respironics reached a $1.1b settlement affecting CPAP and other breathing devices. Toku announced it received US FDA breakthrough device designation for its MyKidneyAI technology. This May, the FDA will hold its REdI conference focusing on innovation in medical product development and hold another townhall focusing on considerations for selecting a sterilization modality.

The US FDA has cleared a glucose monitoring system from Senseonics. The authorization of the implantable insulin delivery system creates a new pathway for like devices.

Front Line Medical Technologies Inc.'s new CE marking expands access of its occlusion device COBRA-OS to medical providers in Europe. Adam Power, chief medical officer at Front Line Medical, talked to Medtech Insight about their marketing plans and benefits of the technology. 

In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb highlights key interviews with Philips’ CEO Roy Jakobs on NAM’s framework on AI, BD’s CTO Beth McCombs R&D initiatives and HSS spine co-chair Sheeraz Qureshi on his vision for integrating AI tech. Hannah Daniel discusses the FDA’s new initiative to create an idea lab for medical device use at home and a new feature on the Apple Watch to help people with Parkinson's disease overcome freezing gait.   

The US has greenlighted Abbott’s Esprit BTK System for treating patients with chronic limb-threatening ischemia below the knee, making it the first dissolvable stent to treat this condition. A Wells Fargo analyst sees a $500m US market opportunity for the implant, which will see limited release in late 2024.

The REMI Remote EEG monitoring system and REMI Vigilenz AI could help patients with infrequent seizures get a quicker diagnosis.

Kids ages 5 and up now can benefit from Cochlear’s Osia implant and sound processor, indicated for hearing loss, mixed hearing loss and single-sided sensorineural deafness.

This week, the US and UK announced a partnership to promote AI safety. Boston Scientific recalls embolic agent. LumiCell received FDA approval for its imaging agent to detect residual cancer. Scout receives an award to develop an STI test; and Osso VR leverages the Apple Vision Pro for VR medical training.

The US FDA has cleared a novel software application to enhance the analysis of bone marrow smears. Using the AI-powered tool, hematopathologists may be able to better diagnose various blood and marrow diseases.

Roche announced on 11 April it received FDA breakthrough device designation for a blood test used for early detection of Alzheimer’s disease.

Technology partners, Orthobond and Onkos Surgical, announced they received FDA de novo approval for their respective technologies to actively kill bacteria that could contaminate medical devices.

This week, Paragonix announced that its BAROguard lung preservation system is now available throughout the US; Brazil planned to leverage some foreign device approvals; Medical Microinstruments’ Symani Surgical System won de novo clearance; and the FDA updated its safety warnings for Essure and certain plastic syringes.

Dozens of researchers signed a letter condemning the AvertD test from SOLVD, which looks for genes that may contribute to a propensity toward opioid addiction. But the FDA and the manufacturer both say the test is effective.

The US Food and Drug Administration released seven warning letters in March 2024, of which three were related to a recent crackdown on China-made syringes. Other letters recounted troubles at Exactech, Fresenius and ReNovo, as well as clinical trial violations from Nobles Medical Technology.

This week, Abbott, Click and Otsuka, Prenosis won the FDA nod respectively for an in vitro diagnostic to evaluate patients for concussion, the first prescription digital therapeutic to treat major depressive disorder and a software to predict sepsis. Also on the regulatory front, the FDA will now take 513(g)s forms via its eSTAR framework. In Europe, the debate of what personal information can be shared continues. 

Abbott wins FDA approval for TriClip regurgitation therapy, which will compete against Edwards Lifesciences’ recently approved Evoque transcatheter tricuspid valve replacement device. Two analysts expect Tricuspid will be eligible for a new technology add-on payment, which will be positive for Abbott.