The devices may be less accurate when used to screen multiple people at once, the US agency says.

The US Food and Drug Administration has cleared Clue as the second app with a birth control indication to reach market – but the first company on the scene questions whether it's as effective as theirs.

Agency heads say the new plan will siphon and aggregate more data that could help the regulatory body make better and faster regulatory decisions.

Notified bodies’ efforts to enhance a harmonized approach to remote audits have failed, raising questions about whether there is any avenue left to get vital devices certified by the 26 May EU MDR deadline.

Schemes and funding to support growth in the life sciences and medtech sectors featured in the UK government’s spring budget on 3 March.

The agency says it has sent letters to dozens of companies that have made ‘FDA Registration Certificate’ claims or used the agency’s logo without authorization, which could lead customers to think the products have been vetted.

Notified bodies’ efforts to enhance a harmonized approach to remote audits have failed, raising questions about whether there is any avenue left to get vital devices certified by the 26 May EU MDR deadline.

The agency says it has sent letters to dozens of companies that have made ‘FDA Registration Certificate’ claims or used the agency’s logo without authorization, which could lead customers to think the products have been vetted.

Quality and regulatory predictions for 2021, a count of 2020 US FDA enforcement missives, a premarket approval case study for a novel prosthetic, and more topped our list of most-read Medtech Insight articles in February.

Hillrom is reconsidering its planned $375m acquisition of Bardy Diagnostics because of Novitas' plan to cut Medicare reimbursement for extended cardiac monitoring. Bardy is suing to complete the deal.

Lumenis’ surgical business includes the MOSES laser system for minimally invasive urology surgery which will complement Boston Scientific’s LithoVue ureteroscope.

The agency says it has sent letters to dozens of companies that have made ‘FDA Registration Certificate’ claims or used the agency’s logo without authorization, which could lead customers to think the products have been vetted.

In this new roundup feature focusing on the most notable developments in digital health, we pick the key news from the year so far. 

Hologic made its third big acquisition of 2021 and Agilent agreed to pay up to $695m for Resolution Bioscience to extend its precision oncology capabilities.

Medtech Insight spoke to attorney Greg Dadika about mass tort litigation, including industry trends, how to find the right law firm, and when it’s the right time to settle a suit.

In this new roundup feature focusing on the most notable developments in digital health, we pick the key news from the year so far. 

Sensyne obtained UK regulatory approval for its SYNE-COV machine learning algorithm to assess the long-term risks of COVID-19.

On this week’s podcast we talk about some hurdles that Swedish start-up Integrum leapt when applying for premarket approval for its Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) Implant System.

Simplify’s total disc replacement complements NuVasive’s C360 line of cervical repair surgery devices, addressing a market that could eventually be worth $2.6bn.

The company’s revenue was down just 1% year-over-year in the third quarter of fiscal 2021, despite the ongoing impact of the pandemic.

Abingdon Health has announced that a study run in conjunction with the UK Rapid Test Consortium has demonstrated that its AbC-19 test could be an effective tool for testing vaccine efficacy.