Edwards Lifesciences has slashed the number of open CAPAs at its Draper, UT, manufacturing site by more than half. See what the company’s director of quality engineering, Dan Buehner, said about it here.

Just as the MDR and IVDR are being implemented, increasing regulatory divergence in Europe is a growing danger to patient safety throughout the EU, not least through increasing costs and impacting device availability.

It’s time to focus on how the diagnostics sector will comply with the EU’s IVD Regulation. TÜV SÜD expert, Andreas Stange, explains why the IVD industry could be in trouble and what must be done now.

US FDA commissioner Stephen Hahn argued on 27 October that his device center should consider more user-fee investments to alleviate the agency’s workload and address new innovations – but industry wants the FDA to finish hiring and work with what’s there.

An EU public-private collaborative project is seeking validation from regulators and health technology assessment bodies regarding its proposed best practice approach to conducting patient preference studies.

No device-related warning letters were released by the US FDA the week of 27 October.

Edwards Lifesciences has slashed the number of open CAPAs at its Draper, UT, manufacturing site by more than half. See what the company’s director of quality engineering, Dan Buehner, said about it here.

The US agency is giving manufacturers of automated external defibrillator accessories roughly 15 more months to comply with a 2015 final order that requires them to file premarket submissions with the agency.

Two Edwards quality experts explain to Medtech Insight how the firm is benefiting by using a new CAPA framework that shifts corrective and preventive action from a one-size-fits-all method to a more nuanced approach that separates higher-risk events from others that don’t need to be elevated to the level of a traditional CAPA.

Cala Health expects to initiate telemedicine-based clinical trials of Cala Trio in patients with Parkinson’s disease by year-end.

In this week’s podcast, Medtech Insight's managing editor Marion Webb has an update from the virtual HLTH panel discussions on telehealth and robotics. Deputy editor Reed Miller discusses trial results from Boston Scientific’s next-generation Accurate neo2 self-expanding aortic valve presented during the Transcatheter Cardiovascular Therapeutics (TCT) meeting. 

Investors in surgical robotics company Auris say Johnson & Johnson failed to support the company per their merger agreement.

The company’s third-quarter sales were up 4% year-over-year as transcatheter aortic valve replacement procedure volumes returned to pre-pandemic levels.

Biovica exec becomes Glycorex Transplantation CEO; Perimeter Medical Imaging AI CFO promoted to CEO; new blood at Aquarius Surgical Technologies, Itamar Medical and NuVasive; and more.

Abbott reported strong sales for diagnostics and devices in the third quarter and raised its full-year EPS guidance to $3.55 per share.

The approval is based on the results ABRE clinical study, which showed the stent improved patency iliofemoral veins in 88% of cases with a 2% rate of major adverse events.

Cala Health expects to initiate telemedicine-based clinical trials of Cala Trio in patients with Parkinson’s disease by year-end.

Abbott reported strong sales for diagnostics and devices in the third quarter and raised its full-year EPS guidance to $3.55 per share.

A randomized trial demonstrated the superiority of Medtronic’s DTM spinal cord stimulation waveform over conventional spinal cord stimulation for treating back pain.

Results from two trials confirm patients at high risk of bleeding treated with Abbott’s Xience stent can be safely treated with short regimens of dual antiplatelet therapy.

The deal gives Medtronic the exclusive right to acquire Half Moon Medical, a start-up developing a mitral valve repair system to compete with Abbott’s MitraClip.