The US FDA has approved a temporary prostatic stent from SRS Medical Systems that allows urine to flow through the urethra when it is blocked by an enlarged prostate.

Are too few digital health care apps approved for reimbursement in Germany? That’s not the point, says the health care ministry, urging a look at the bigger strategic picture.

The latest notified body listing brings total number of EU designated Medical Device Regulation testing and certification organizations to 35.

Steps are being taken in the EU to address shortages of critical medical devices as a result of regulatory pressures, including those for use in children and for rare conditions, the European Commission’s Stella Kyriakides stated during a recent debate.

Another key stage has been reached in Switzerland’s bid to enable US FDA-approved medtech to be used in the local population.

A color additive evaluation tool for polymeric medical devices was approved as an MDDT under the FDA’s voluntary program.

The latest notified body listing brings total number of EU designated Medical Device Regulation testing and certification organizations to 35.

Work is progressing towards publications of an updated list of standards to support implementation of the EU’s new medtech regulations.

The EU needs to go further when it comes to allowing the use of electronic IFU for all professional use medical devices and fall more closely into line with other global markets.

GE Healthcare and MediView announced a partnership to co-develop a technology platform that integrates medical imaging into mixed reality solutions.

The US FDA has approved a temporary prostatic stent from SRS Medical Systems that allows urine to flow through the urethra when it is blocked by an enlarged prostate.

Medtech Insight followed-up with Cordis CEO Shar Matin to talk about the company’s path forward as an innovative intervention company following the acquisition of MedAlliance.

Insulin pumps have lagged behind continuous glucose monitors in terms of market penetration due to their cost and the complex regulatory framework that surrounds them. Elizabeth Gasser, chief strategy officer at Tandem Diabetes spoke to Medtech Insight about these challenges and how the company is taking a slightly different approach to pumps.

The Jefferies London Healthcare Conference 2022 was packed with big medtech names, with Siemens Healthineers, Smith & Nephew and CMR Surgical among presenters. In-between seminars, Medtech Insight was able to glean some candid insights into medtech, pharma and finance that are rarely given freely.

A newly cleared Apple Watch app will allow people living with Parkinson’s to more easily track tremors, dyskinesia and other symptoms.

GE Healthcare and MediView announced a partnership to co-develop a technology platform that integrates medical imaging into mixed reality solutions.

A newly cleared Apple Watch app will allow people living with Parkinson’s to more easily track tremors, dyskinesia and other symptoms.

This year’s annual HLTH meeting drew more than 9,000 people to Las Vegas from 13-16 November and hundreds of exhibitors. In this first part of a two-part roundup, Medtech Insight highlights interviews with C-suite executives at Mirvie, Grail, Biofourmis, Komodo Health and Babson Diagnostics.

One-year data from a randomized controlled trial showed Zimmer Biomet’s mymobility app paired with the Apple Watch can effectively guide rehabilitation following knee-replacement surgery.

Founded with a vision to change point-of-care diagnostics, Osler Diagnostics has raised nearly $200m to develop and commercialize a platform that promises to revolutionize diagnostics with just a drop of a patients’ blood.

NuraLogix developed machine-learning models that use facial blood flow patterns to predict disease. The company plans to pursue US FDA de novo authorization for its blood pressure monitoring module first in 2023.